Supplementary appendix
This appendix formed part of the original submission and has been peer reviewed.
We post it as supplied by the authors.
Supplement to: Michaleff ZA, Maher CG, Lin C-WC, et al. Comprehensive physiotherapy
exercise programme or advice for chronic whiplash (PROMISE): a pragmatic randomised
controlled trial. Lancet 2014; published online April 4. http://dx.doi.org/10.1016/
S0140-6736(14)60457-8.
CHRONIC WHIPLASH EXERCISE TRIAL PROTOCOL
Web appendix 1: Trial protocol
Chronic Whiplash Exercise Trial
A randomised controlled trial of a comprehensive exercise program for chronic whiplash
The University of Sydney HREC reference number: 03-2009/11509
The University of Queensland project number: 2008002059
Study Protocol
(Draft 7 dated 14/05/2010)
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Chronic Whiplash Exercise Trial Summary Sheet
Name of Sponsors:
The George Institute For International Health
The University of Queensland
Title of Study:
A randomised controlled trial of a comprehensive exercise program for chronic whiplash.
Principal Investigators:
Professor Chris Maher, The George Institute for International Health, Australia.
Associate Professor Michele Sterling, Centre for National Research on Disability and Rehabilitation Medicine
(CONROD), University of Queensland, Australia.
Study Sites:
The study will recruit participants from Sydney and Brisbane.
Study Period (years): January 2009 to
May 2012
Phase of Development: Phase III
Duration: 3 years
Objectives:
1. The primary aim of this randomised controlled trial is to establish the effectiveness of a comprehensive exercise
program for people with chronic (symptoms > 3 months < 5 years duration) whiplash.
2. The second aim is to conduct an economic evaluation of the exercise program.
3. The third aim is to investigate if sensory hypersensitivity and symptoms of posttraumatic stress modify the effect of the
program.
Methodology:
The study will be a randomised controlled trial comparing a comprehensive exercise program, consisting of 20 one-hour
supervised exercise sessions over a twelve-week period, to an educational booklet for people with chronic whiplash.
Outcomes measures will be assessed at baseline, 14 weeks, 6 and 12 months.
Participants will be recruited through written contact to claimants who are registered with the Motor Accidents Authority
of New South Wales and through advertisements in Sydney and Brisbane print media.
Planned number of participants:
- Total: 172 participants (i.e. 86 participants from Sydney and 86 participants from Brisbane)
- Comprehensive exercise program: 86 participants
- Advice and booklet: 86 participants
Diagnosis and main criteria for inclusion:
- Grade I or II whiplash of at least 3 months duration but less than 5 years duration.
- Currently experiencing at least moderate pain or moderate activity limitation due to pain (modified items 7 & 8 of
SF36).
- Not currently receiving care for whiplash.
Duration of follow-up:
One year
Statistical methods
Treatment efficacy variables: We will analyse the effect of treatment separately for each outcome using linear mixed
models with time as a repeated factor. The model will account for correlation over time within participants, correlation
within clinics and potential confounders (e.g. important prognostic factors).
Effect modifiers: Effect modification will be assessed by including a predictor-by-treatment group-by-time interaction term
to the mixed models analyses. Effect modification will only be assessed for the primary outcome of average pain intensity
over the last week.
Economic analysis: The cost-effectiveness of each mode of care will be assessed using the cost and health preference data
(the latter of which will be used to generate QALYs).
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Chronic Whiplash Exercise Trial Summary Sheet (continued)
Name of Sponsors:
The George Institute For International Health
The University of Queensland
Contractual signatories
I confirm that I have read and agreed to
the Chronic Whiplash Exercise Trial Draft
6, dated 4/09/2009 for the study titled ‘A
randomised controlled trial of a
comprehensive exercise program for
chronic whiplash’
Principal Investigator (NSW)
Principle Investigator (QLD)
Name
Date
Signature
Professor Chris Maher
Associate Professor
Michele Sterling
The George Institute For International
Health
The University of Queensland
Motor Accidents Authority NSW
David Andrews
Motor Accidents Insurance Commission
Queensland
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TABLE OF CONTENTS
1.
2.
3.
4.
4.1
5.
5.1
5.2
ETHICS AND CONFIDENTIALITY .......................................................................................................................... 5
ADMINISTRATIVE STRUCTURE ............................................................................................................................ 6
INTRODUCTION.................................................................................................................................................... 7
OBJECTIVES....................................................................................................................................................... 11
Aims and hypotheses of the study ................................................................................................................. 11
STUDY DESIGN ................................................................................................................................................... 12
Design ........................................................................................................................................................... 12
Participants .................................................................................................................................................... 14
5.2.1 Participant recruitment .............................................................................................................................. 14
5.2.2 Inclusion criteria ....................................................................................................................................... 14
5.2.3 Exclusion criteria ...................................................................................................................................... 14
5.3
Study Interventions ....................................................................................................................................... 16
5.3.1 Baseline assessment .................................................................................................................................. 16
5.3.2 Randomisation .......................................................................................................................................... 16
5.3.3 Educational booklet................................................................................................................................... 16
5.3.4 Comprehensive exercise program ............................................................................................................. 16
5.3.5 Treatment sites .......................................................................................................................................... 18
5.3.6 Follow up .................................................................................................................................................. 18
5.3.7 Premature discontinuation of randomised intervention ............................................................................. 18
5.4
Study Outcomes ............................................................................................................................................ 18
5.4.1 Outcomes Assessments ............................................................................................................................. 18
5.4.2 Primary outcome ....................................................................................................................................... 18
5.4.3 Secondary outcomes ................................................................................................................................. 18
5.4.4 Participant diary ........................................................................................................................................ 19
5.4.5 Economic evaluation ................................................................................................................................. 19
5.4.6 Reporting of adverse events ...................................................................................................................... 19
5.5
Study Sequence ............................................................................................................................................. 20
5.5.1 Telephone screening.................................................................................................................................. 20
5.5.2 Baseline Assessment ................................................................................................................................. 20
5.5.3 Randomisation .......................................................................................................................................... 20
5.5.4 Physiotherapy treatment clinic .................................................................................................................. 21
5.5.5 14 weeks, 6 and 12 month follow up assessments .................................................................................... 21
5.6
Quality Assurance ......................................................................................................................................... 22
5.6.1 Monitoring of study sites .......................................................................................................................... 22
5.6.2 Data integrity............................................................................................................................................. 22
5.7
Statistical Issues ............................................................................................................................................ 22
5.7.1 Statistical analysis and methodological considerations ............................................................................. 22
5.7.2 Sample size ............................................................................................................................................... 22
5.8
Indemnity ...................................................................................................................................................... 23
5.9
Publications and reports ................................................................................................................................ 23
5.10
Funding ......................................................................................................................................................... 23
5.11
Timeline ........................................................................................................................................................ 23
6.
REFERENCES: .................................................................................................................................................... 24
7.
APPENDICES ...................................................................................................................................................... 26
Appendix 1 – Promise advertisement .......................................................................................................................... 26
Appendix 3 – Phone screening..................................................................................................................................... 30
Appendix 6 – Telephone script to arrange follow-up assessments .............................................................................. 34
Appendix 9 – Outcome assessments ............................................................................................................................ 41
Appendix 10 – Measuring cervical spine range of movement: inclinometer method .................................................. 57
Appendix 11– Measuring cold pain threshold over the cervical spine......................................................................... 58
Appendix 12 – Measuring pressure pain threshold over the cervical spine and the tibialis anterior ........................... 59
Appendix 13 – Utility weights: instruction and recording sheet .................................................................................. 59
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1. Ethics and confidentiality
Approval for the Chronic Whiplash Exercise Trial has been obtained from the University of Sydney Human Research
Ethics Committee (03-2009/11509) and the University of Queensland Human Research Ethics Committee
(2008002059). Written informed consent, complying with local requirements, will be obtained from all participants
prior to entry into the study. The study will not commence in any centre until all the necessary documentation has been
completed.
In obtaining informed consent, the study staff will provide the potential participant with information about the
purposes, methods, possible risks and benefits of participating in the study. All potential participants will have an
opportunity to discuss the trial with study staff. The participant and the person obtaining informed consent will each
sign and date two copies of the consent form, one copy of which will be provided to the participant and the other copy
of which will be stored in the participant’s case record folder. Involvement in the study will be voluntary and all
participants will have the opportunity to withdraw from the study at any time without prejudice to their current or future
medical management. In the event of a participant wishing to withdraw from the study, they will be required to verbally
contact study staff and notify them of their decision.
Modifications to the protocol, participant information sheet or consent form will be submitted to the ethics committee
for approval and appended to this document. Such modifications will only be implemented once ethics committee
approval has been obtained, unless an amendment is being made to eliminate immediate hazards to study participants.
All data generated by the study will remain strictly confidential and no report will contain any information that would
allow an individual participant in the study to be identified. However, in order to facilitate complete data collection and
follow-up individual contact details will be collected at registration and secured in locked filing cabinets with limited
access. These details will be stored separate from other data. Participant records at treatment provider clinics will be
identified by participant name or initials and their unique randomisation number.
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2. Administrative structure
This investigator-initiated study is sponsored by The George Institute For International Health and The University of
Queensland. The study is funded by the Motor Accidents Authority of New South Wales, Motor Accidents Insurance
Commission Queensland and the National Health and Medical Research Council. The principle investigators and coinvestigators will be responsible for overseeing all aspects of the trial and they will be responsible for the preparation
and publication of the principal results of the study.
The study will be conducted in Sydney and Brisbane. Each site will be responsible for participant recruitment, follow
up and coordination of the trial.
PRINCIPLE INVESTIGATORS
Professor Chris Maher
The George Institute For International Health and
University of Sydney
Tel: (02) 9657 0382
Fax: (02) 9657 0301
Email: cmaher@george.org.au
Associate Professor Michele Sterling
Centre for National Research on Disability and
Rehabilitation Medicine (CONROD)
University of Queensland
Tel:(07) 3365 5344
Fax: (07) 3346 4603
Email: m.sterling@uq.edu.au
CO-INVESTIGATORS
Professor Gwendolen Jull
School of Health and Rehabilitation Sciences
University of Queensland
Tel: (07) 3365 1114
Fax: (07) 3365 1622
Email: g.jull@uq.edu.au
Dr Trudy Rebbeck
Specialist Musculoskeletal Physiotherapist
Discipline of Physiotherapy
University of Sydney
Tel: (02) 9363 0490
Fax: (02) 9326 2203
Email: T.Rebbeck@usyd.edu.au
Associate Professor Jane Latimer
The George Institute For International Health and
University of Sydney
Tel: (02) 96570 384
Fax: (02) 9657 0301
Email: jlatimer@george.org
Matt Roodveldt
Centre for National Research on Disability and
Rehabilitation Medicine (CONROD)
University of Queensland
Professor Luke Connelly
University of Queensland
Tel: (02) 9926 7351
Fax: (02) 99061859
Email: l.connelly@uq.edu.au
Miss Zoe Michaleff
The George Institute For International Health and
University of Sydney
Tel: (02) 9657 0321
Fax: (02) 9657 0301
Email: zmichaleff@george.org.au
Dr Christine Lin
The George Institute For International Health and
University of Sydney
Tel: (02) 8238 2437
Fax: (02) 9657 0301
Email: clin@george.org.au
Stephanie Valentin
Centre for National Research on Disability and
Rehabilitation Medicine (CONROD)
University of Queensland
Research assistant
Email: s.valentin@uq.edu.au
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3. Introduction
3.1 Background
3.1.1 The problem of chronic whiplash
The most common injury following a motor vehicle accident is a whiplash injury to the neck and this injury
is of particular concern because it usually results in persisting pain and disability in an otherwise healthy
young adult2 3. At present, there is no known effective treatment for those who suffer persistent pain
following a whiplash injury. In our view part of the reason for the lack of attention to whiplash is that many
people under-estimate the significance of this health problem. The media has likely contributed to this
misconception as it has often trivialised whiplash by commonly depicting people who feign an injury. The
reality is quite different.
In Australia and abroad the personal and economic burden of whiplash is enormous. For example, in New
South Wales in the period 1989-1998 there were 50,000 whiplash claims costing ~$1.5billion4. Whiplash is
also notoriously difficult to manage with the most frequent outcome following a whiplash injury being
persisting pain and disability. Our research in NSW2 and in Queensland3 revealed that ~60% of people are
still in pain and disabled 6 months after the original accident. The ongoing symptoms affect quality of life
with our data showing SF36 scores markedly lower than Australian norms2. Our recent systematic review
of the prognosis of acute whiplash revealed similar health outcomes in other countries around the World5.
With the number of cars in the World to double over the next 30 years there is an urgent need for effective
and affordable treatments for chronic whiplash.
3.1.2 Limited treatment options for chronic whiplash
The 2007 Cochrane review6 concluded that there are no clearly effective non-surgical treatments for
chronic whiplash. The few trials published subsequent to the review do not change this conclusion. The
reality is that available treatments have at best very small effects. There is however one surgical technique
where there is clear evidence of efficacy: radiofrequency neurotomy7. With this surgical procedure a needle
is used to burn, and so destroy, the nerves that transmit pain from the damaged zygapophyseal joints in the
lower cervical spine. This treatment is only indicated for the sub-group of patients whose symptoms arise
from these joints. Moreover there are major limitations to this treatment. The procedure is technically
difficult surgery and offers only temporary relief of symptoms and needs to be repeated when the nerves
recover and pain returns. Because of these limitations radiofrequency neurotomy, on its own, cannot
provide a solution to the problem of chronic whiplash. For the majority of sufferers with chronic
whiplash there are currently no proven effective therapies.
3.1.3 Developing an effective exercise program for chronic whiplash
Over the last five years the chief investigators have been working to develop an effective treatment for
chronic whiplash that avoided the limitations of neurotomy. The first developments were two different
exercise programs: graded activity and specific exercise. The programs were evaluated in separate
randomised controlled trials8 9 with each trial demonstrating that the program was effective. While these
results were very promising, and have been published in the leading journal Pain, it was apparent that only
10-20% of participants had a completely successful outcome (see Figure 1). In the investigators’ opinion
this success rate was too low to represent a solution to the problem of chronic whiplash. Further
development was necessary.
The features of an exercise program such as the type of exercise, intensity and duration are key
determinants of the effects of exercise10. By varying these parameters it could be possible to increase the
success rates of the previous exercise programs. We chose not to increase the intensity or dose of exercise
because this would increase the risk of side-effects such as exacerbation of symptoms. Instead we opted to
combine both treatments. We reasoned that because the two forms of exercise address different
impairments seen with whiplash, it is likely that a program that combined both approaches would provide
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greater results. Accordingly we developed a comprehensive exercise program that combined both
approaches yet could still be readily implemented by any physiotherapist.
The principle investigators conducted a small uncontrolled phase I/II trial that provided results which
confirmed our hypothesis (see Figure 2). This comprehensive program had a much higher success rate with
56% of subjects having minimal or no disability at the end of the program. This success rate approximates
that of radiofrequency neurotomy (58%) but importantly avoids the serious limitations of this treatment.
probablity of a successful outcome
100%
Figure 1. Superior results of the comprehensive
exercise program. Figure shows % of subjects with
minimal or no disability following graded activity,
specific exercise and the new comprehensive exercise
program.
80%
60%
40%
20%
0%
Graded activity
Specific
exercise
New program
3.1.4 Why the better effect with both treatments combined?
We believe that there are sound theoretical reasons to explain why the comprehensive exercise program
would provide a substantially greater probability of success. The initial specific neck exercise program
restores the functions of the muscles that control and support the neck. The graded activity program
improves the patient’s general fitness and teaches the patient how to successfully undertake activities of
daily living that they find problematic. Without first ensuring that the neck musculature is able to control
and support the neck a graded activity program could potentially exacerbate a patient’s symptoms.
Similarly unless a specific exercise program is followed by a graded activity program the improved support
and control of the neck may not translate into improved ability to participate in activities of daily living. It
is only when both treatments are combined in an integrated package that the foundations for success
are provided.
Based upon the exciting results of the pilot study and its strong biological rationale, we now propose to
definitively establish the effectiveness of this comprehensive program in a large phase III randomised
controlled trial.
3.1.5 Predicting response to treatment: effect modifiers
In our pilot trial we found that ~60% of subjects responded to the comprehensive exercise program. It
would obviously be of great value to be able to identify people with a high likelihood of success so that
treatment resources are not wasted on people who will not respond to this program. We believe that we
may be able to identify this group based upon clinical characteristics.
Our research has demonstrated that whiplash is not a homogeneous condition. Rather sub-groups can be
identified that display varying degrees of physical and psychological disturbance11 12. Most patients
demonstrate a fairly uncomplicated clinical presentation of mild to moderate levels of pain and disability,
mild psychological distress and motor dysfunction. At the other end of the spectrum, there is a group of
whiplash patients (approx 25%) who demonstrate a complex clinical picture including moderate/severe
levels of pain and disability associated with marked sensory disturbance (widespread hyperalgesia,
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sympathetic nervous system dysfunction) indicative of central nervous system hypersensitivity13 14. In
association with sensory disturbance these patients also display symptoms of a moderate posttraumatic
stress reaction15.
We have shown that the presence of sensory hypersensitivity and/or symptoms of posttraumatic stress are
strongly predictive of poor long-term outcome3 15. Additionally the presence of sensory changes in chronic
whiplash moderated the effects of our specific exercise treatment intervention9. The influence of
posttraumatic stress on the effects of exercise intervention in whiplash has never been investigated. It is
likely that these factors will also influence the effects of a combined exercise therapy approach and for this
reason we believe their evaluation as potential treatment effect modifiers is mandatory.
3.2 Summary
The aim of the proposed research is to determine the effectiveness of a comprehensive exercise program for
chronic whiplash. Currently, for the majority of sufferers with chronic whiplash there are no proven
therapies available to manage this personal and financially costly condition. Promising results have been
identified in randomised controlled trials evaluating the effects of different exercise programs, graded
activity and specific exercise. However, success rates from these studies were too low to represent a
solution to the problem of chronic whiplash and further development was necessary.
A comprehensive exercise program that combined both specific exercises and graded activity was
developed. A small uncontrolled phase I/II trial provided evidence that this new exercise program had a
much higher success rate with 56% of subjects having minimal or no disability at the end of the program.
This success rate approximates that of radiofrequency neurotomy (58%) but avoids such invasive surgical
techniques.
Based upon the exciting results of the pilot study and the strong biological rationale for the superior results
with the combined program we now propose to definitively establish the effectiveness of the new program
in a large phase III randomised controlled trial.
3.2.1 Planned outcomes
Our choice of outcomes is consistent with the recommendations of the Cochrane Back Review Group16 and
our previous study of the responsiveness of these measures17. Measures of symptoms, global recovery,
functional status, quality of life and side effects will be taken. We have chosen a patient-specific measure
of functional status because there is evidence that this is more responsive than a condition-specific
measure18. We have included the most widely used whiplash-specific (Whiplash Disability Questionnaire)
and neck-specific (Neck Disability Index) measures of functional status to allow comparison of our results
with those from other studies.
The main study results will be submitted for publication in a prominent journal with all actively
collaborating investigators acknowledged. The George Institute Marketing and Communication staff will
ensure that both the conduct and the results of this study are widely and reliably publicised in the general
media, including newspaper, radio talk-back program and TV news items.
3.2.2 Potential Significance
This study will provide a definitive evaluation of the effectiveness and cost-effectiveness of a
comprehensive exercise program for chronic whiplash. The evaluation of this treatment is critical because
for most people with chronic whiplash there are no known effective treatments.
Based upon the results of our pilot study we believe we have developed a simple, cost effective, nonsurgical treatment that will decrease pain and disability associated with chronic whiplash and will be
available for use by any physiotherapist. The pilot data suggest it would benefit most people with chronic
whiplash.
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The new therapy has resulted from collaboration between Australia’s leading whiplash researchers from
The George Institute For International Health and The University of Queensland. This collaboration has
allowed us to successfully combine two philosophically and procedurally disparate interventions into a
new, simple procedure. The two components have been tested in separate clinical trials and the
comprehensive program in a small phase I/II trial. This rigorous scientific approach to developing new
treatments is rare in the field of spinal pain and represents a major advance. A search of the WHO
International Clinical Trials Registry Platform Search Portal on 28/07/09 revealed no planned or completed
trial that would duplicate our work.
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4. Objectives
4.1 AIMS AND HYPOTHESES OF THE STUDY
• The primary aim of this project is to establish the effectiveness of a comprehensive exercise program
for chronic whiplash. This program integrates specific motor relearning and graded activity exercises
and will be assessed in terms of pain, disability, patient’s global impression of recovery and quality of
life.
• The second aim is to conduct an economic evaluation of this comprehensive exercise program.
• The third aim is to investigate if sensory hypersensitivity and symptoms of posttraumatic stress modify
the effect of the comprehensive program.
It is hypothesised that:
• The effect of the comprehensive exercise program will be greater than that of an educational booklet
where effect is measured in terms of pain, disability, patient’s global impression of recovery and
quality of life.
• The comprehensive exercise program will be more cost-effective than an educational booklet.
• The presence of sensory hypersensitivity and/or symptoms of posttraumatic stress modify the effect of
the comprehensive program.
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5. Study design
5.1 DESIGN
The study will be a randomised controlled trial evaluating the comprehensive exercise program (specific
motor relearning and graded activity exercise) for people with chronic whiplash. A total of 172 voluntary
participants with chronic (symptoms > 3 months <5 years duration) whiplash will be randomly allocated to
receive either 20 one hour sessions of the comprehensive exercise program over 12 weeks in conjunction
with the educational booklet or the educational booklet alone (86 participants per group). Outcomes will be
measured at 14 weeks, 6 and 5 years. Results of the treatment program will be supplemented by an
economic evaluation of the direct and indirect costs incurred by both the comprehensive exercise program
participants and those receiving the educational booklet only.
The overall design is illustrated in Figure 5.1.
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Figure 5.1 Study design
Invitation to participate in the study from list of
claimants registered with MAA or through print media.
Volunteers respond.
Participants screened for eligibility via phone call.
Inclusion criteria:
• Grade I or II whiplash (duration > 3 months < 5
years).
• Moderate pain OR moderate activity limitation due
to pain.
• Not currently receiving care for whiplash.
• Aged between 18 and 65 years old.
• Proficient in written and spoken English
• Able to attend 4 assessment sessions at the trial
centre
Exclusion criteria:
• Serious spinal pathology (e.g.
metastatic disease of the spine, spinal
fracture).
• Nerve root compromise.
• Spinal surgery in the past 12 months.
• Co-existing medical condition which
would severely restrict participation in
the exercise program.
• Any of the contraindications to
exercise listed in the ACSM
guideline1.
Trial centre screening + baseline measures
- Age, gender, level of education
- Outcomes
- Effect modifiers
Concealed random allocation at the trial centre.
Referral and initial appointment organised for
participant at Physiotherapy treatment site.
COMPREHENSIVE EXERCISE PROGRAM +
EDUCATIONAL BOOKLET
Week 1 – 4: Specific exercise program assessment
and prescription
(2 sessions per week for 4 weeks)
ADVICE AND EDUCATIONAL BOOKLET
Participants are allowed to contact the
physiotherapist by phone (up to two times only) to
clarify information/exercises contained in the
educational booklet
Week 5 – 12: Graded activity program assessment
and prescription
(12 sessions over 8 weeks)
14 week assessment (outcomes, side effects, other pain-related treatments and costs)
6 month assessment (outcomes, other pain-related treatments and costs)
12 month assessment (outcomes, other pain-related treatments and costs)
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5.2 PARTICIPANTS
5.2.1 Participant recruitment
A total of 172 participants with chronic (symptoms > 3 months <5 years duration) whiplash will be
recruited from the Brisbane and Sydney sites. Participants will be identified through advertisements
(Appendix 1) in local and larger metropolitan print media. In NSW participants will also be recruited with
the assistance of the Motor Accidents Authority (MAA). The MAA will identify claimants from their
database who have sustained a whiplash injury in a motor vehicle accident between two and eleven months
previously, this allows time for people to respond and be assessed. These claimants will have a letter sent to
them courtesy of the MAA (Appendix 2) informing them of the study and inviting them to participate.
People who respond to the invitation to participate in the study will subsequently be screened via a
telephone call to identify their eligibility to participate in the trial (Appendix 3). Screening will include a
Physical Readiness Questionnaire (PAR-Q) and questions assessing for “red flags”. A positive response to
questions in these two screening tools will result in either further review at the trial centre to clarify the
response or exclusion from participating in the trial.
Volunteers who meet the phone screening criteria will be asked to attend the trial centre where written
consent (Appendix 4), and baseline measures will be obtained. A neurological examination will be
completed if indicated by the screening procedures (Appendix 5). Immediately following baseline
assessment, participants will be randomised and allocated to either the treatment (comprehensive exercise
program and educational booklet) or the control group (educational booklet only).
A record will be kept of the number of invitations sent out by the MAA (NSW only), the number of
potential participants who volunteer to participate, the number of people screened and their eligibility
status, if ineligible the reason for their ineligibility will also be documented. The researchers will only have
access to the number of invitations, and not to the original records to ensure confidentiality. Therefore,
researchers will not have any information about potential participants unless they are recruited into the
study.
5.2.2 Inclusion criteria
Participants will be included if they meet all of the following inclusion criteria:
• Grade I or II whiplash of at least 3 months duration but less than 5 years duration (Figure 5.2).
• Currently experiencing at least moderate pain OR moderate activity limitation due to pain (modified
items 7 & 8 of SF36).
• Not currently receiving care for whiplash.
• Aged between 18 years and 65 years old.
• Proficient in written and spoke English.
5.2.3 Exclusion criteria
Participants will be excluded if they have any of the following:
Known or suspected serious spinal pathology (e.g. metastatic disease of the spine).
Confirmed fracture or dislocation at time of injury.
Nerve root compromise.
Spinal surgery in the past 12 months.
Any coexisting medical condition which would severely restrict participation in the exercise
program e.g. traumatic brain injury.
• Any of the contraindications to exercise listed in the ACSM guideline1 as assessed using the PAR-Q
and listed below:
•
•
•
•
•
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1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
Absolute Contraindications to exercise
A recent significant change in the resting ECG suggesting infarction or other acute cardiac events.
Recent complicated myocardial infarction.
Unstable angina.
Uncontrolled ventricular dysrhythmia.
Uncontrolled atrial dysrhythmia that compromises cardiac function.
3rd degree A-V block.
Acute congestive heart failure.
Severe aortic stenosis.
Suspected or known dissecting aneurysm.
Active or suspected myocarditis or pericarditis.
Thrombophlebitis or intracardiac thrombi.
Recent systemic or pulmonary embolus.
Acute infection.
Significant emotional distress (psychosis).
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
Relative Contraindications
Resting diastolic blood pressure > 120 mmHg or resting systolic blood pressure >200 mmHg.
Moderate valvular heart disease.
Known electrolyte abnormalities (hypokalemia, hypomagnesemia).
Fixed-rate pacemaker (rarely used).
Frequent or complex ventricular ectopy.
Ventricular aneurysm.
Cardiomyopathy, including hypertrophic cardiomyopathy.
Uncontrolled metabolic disease (e.g. diabetes, thyrotoxicosis, or myxedema).
Chronic infectious disease (e.g. mononucleosis, hepatitis, AIDS).
Neuromuscular, musculoskeletal, or rheumatoid disorders that are exacerbated by exercise.
Advanced or complicated pregnancy.
Figure 5.2 – Clinical Classification of Grades of WAD
WAD CLASSIFICATION
0
I
II
III
IV
No complaint about the neck.
No physical sign(s).
Neck complaint of pain, stiffness or tenderness only.
No physical sign(s).
Neck complaint AND musculoskeletal sign(s).
Musculoskeletal signs include decreased range of motion and point tenderness.
Neck complaint AND neurological sign(s).
Neurological signs include decreased or absent tendon reflexes, weakness and sensory
deficits.
Neck complaint AND fracture or dislocation.
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5.3
STUDY INTERVENTIONS
5.3.1 Baseline assessment
Participants who meet the inclusion criteria will attend the trial centre where all of the primary, secondary
baseline measures as well as the effect modifiers will be obtained by a blinded investigator.
5.3.2 Randomisation
Participants will be randomly allocated to treatment group. The randomisation schedule will be generated
by an independent investigator using a computer program prior to the commencement of the trial.
Randomisation will be stratified for each of the trial centres (NSW and QLD) however not for each
individual treatment clinics. Consecutively numbered, sealed, opaque envelopes will be used to conceal
randomisation.
Allocation will occur immediately following the baseline assessment. At this time, an independent
(unblinded) researcher will select the next envelope in the box, record the participant’s randomisation
number and then open the envelope. In this way concealment of allocation and blinding of baseline
measures is ensured. Participants will be considered to have entered the study at the time that the envelope
is opened. The independent researcher who randomised the participant will then arrange the initial
appointment with the treatment provider site within one week of randomisation. The participant proforma
and randomisation envelope will be sent to the treatment clinic prior to the participant’s initial appointment.
Those randomised to receive the comprehensive exercise program and educational booklet will have one
hour allocated to the initial consultation whilst those in the booklet only group will have a half hour
consultation.
Participants in both groups will be asked not to seek other treatments and where possible not to change
current medications for the twelve-week trial period. Furthermore, the insurance company handling the
participant’s claim and the nominated general practitioner will be notified in writing of the individual’s
participation in the trial. They will be asked within reason to refrain from referring or suggesting additional
or alternative treatments to the individual for the initial twelve weeks after randomisation.
5.3.3 Educational booklet
All participants will be provided with the educational booklet ‘Whiplash injury recovery: a self
management guide’ written by Professor Gwen Jull and published by the Motor Accident Insurance
Commission of Queensland19 The booklet provides information about whiplash, provides advice on how to
manage symptoms of whiplash and explains and illustrates an exercise program for whiplash.
Participants randomised to receive the educational booklet alone will have one, half-hour physiotherapy
consultation where the participant will have time to read the booklet provided, have any questions clarified
and be shown the exercises. Participants in this group will, if required, be able to contact the
physiotherapist by phone on two occasions to clarify the information/exercise contained in the educational
booklet. These participants will subsequently be followed up at the trial centre at 14 weeks, 6 and 12
months after the baseline assessment.
5.3.4 Comprehensive exercise program
Participants in the exercise group will in addition to the educational booklet receive the comprehensive
exercise program outlined below. Twenty, one-hour treatment session will be delivered by physiotherapists
trained specifically to implement the trial treatment over a 12 week period (Table 5.3.4). Please refer to the
‘Therapists Protocol’ for more detail.
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Table 5.3.4 Outline of the Comprehensive Exercise Program
Week
Sessions per Components
week
1
2
Specific motor relearning exercise component:
Baseline & follow-up assessments to guide initial prescription & progression of
2
2
program
Exercises to improve cervical and scapular muscle control, kinaesthesia & balance
3
2
Manual therapy if indicated
Education and advice
4
2
Progressive home exercise program, aerobic exercise program
TRANSITION
5
2
6
2
7
2
8
2
9
1
10
1
11
1
12
1
Graded activity component:
Baseline & follow-up assessments to guide initial prescription & progression of
program
Supervised gym-based exercise to improve the participant’s functional abilities –
progress aerobic, range of motion, strength, endurance, coordination and functional
exercises.
Daily home program including exercise & graded increase of physical activities
Graded activity program using Cognitive Behavioural Therapy (CBT) principles
Discharge session to reinforce progress and plan for continued activity
Specific motor relearning exercise component (8 sessions over 4 weeks)
The program begins with a clinical examination of the cervical muscles and the axio-scapular-girdle
muscles and includes tests that assess ability to recruit the muscles in a coordinated manner, tests of
balance, cervical kinaesthesia and eye movement control and tests of muscle endurance at low levels of
maximum voluntary contraction. The specific impairments that are identified are then addressed with an
exercise program that is supervised and progressed by the physiotherapist with cognitive behaviour
principles (e.g. positive reinforcement and encouragement of skill acquisition by modelling) implemented
as required. This specific treatment program has been described in detail20 and focuses on activating and
improving the co-ordination and endurance capacity of the neck flexor, extensor and scapular muscles in
specific exercises and functional tasks, and a graded program directed to the postural control system,
including balance exercises, head relocation exercises and exercises for eye movement control. Manual
therapy and/or general whole body aerobic exercise will be prescribed as required by the treating
physiotherapist. Participants are expected to practise at home the motor skills they are learning in the
therapy sessions. These exercises will be outlined in a home exercise diary which will also be used to
monitor participant’s compliance with the program.
Graded activity component (12 sessions over 8 weeks)
Transition to the graded activity program is flexible and is dependant on the individual’s progress through
the earlier stage. The graded activity program can therefore commence between weeks four to six. At the
first graded activity exercise session, baseline measures of upper and lower body mobility, coordination,
strength and aerobic fitness are taken. From these measures an individualised, sub-maximal, progressive
activity program will be developed to train those functions found to be inadequate for performance of preinjury work and home activities. The physiotherapist will guide the participant's return to normal activities
using the principles of cognitive-behavioural therapy21 specifically: the encouragement of skill acquisition
by modelling, setting progressive goals, self-monitoring of progress, and positive reinforcement of
progress. Self-reliance will be fostered by encouraging participants to engage in problem-solving to deal
with difficulties rather than seeking reassurance and advice, by encouraging relevant and realistic activity
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goals, and by encouraging self-reinforcement. Daily physical activity at home will be encouraged and
monitored using a diary. Written and illustrated exercise instructions will be provided.
5.3.5 Treatment sites
Treatment sites in Sydney and Brisbane will be located in areas easily accessible by public transport. Prior
to the commencement of the trial physiotherapists at each treatment site will be provided with a trial and a
therapist protocol, they will also be trained to implement the comprehensive exercise program by senior
investigators at a one day workshop.
5.3.6 Follow up
Measures of outcomes will be taken at 14 weeks, 6 and 12 months after randomisation. To maximise
attendance at these follow-ups, appointments will be made by phone (Appendix 6) and then a letter
(Appendix 7) will be sent confirming appointment and a phone call 24hours before. Every attempt (within
ethical constraints) will be made to obtain outcome data, regardless of the participant’s compliance with the
trial protocol. Assessments will be conducted by a blinded investigator. At each follow up, information on
the use of other pain-related treatments e.g. health services or medications will be obtained through the
economic cost diary. Only at the 14 week follow up will information about side effects be collected from all
participants using open-ended questioning.
5.3.7 Premature discontinuation of randomised intervention
Participants will have the opportunity to withdraw from the study at any time without prejudice to their
current or future medical management. In the event of a participant wishing to withdraw from the study,
they will be required to verbally contact study staff and notify them of their decision. Regardless of
whether the participant continues to adhere to one or both of the intervention arms, the follow-up schedule
should continue unchanged for all randomised participants. If any participant is not able to attend all of the
scheduled visits then as far as possible, follow-up should be completed by other means (e.g. alternate visits
or telephone follow-up), unless the participant states that he/she also wishes to withdraw from the followup assessments.
5.4
STUDY OUTCOMES
5.4.1 Outcomes Assessments
At the baseline assessment, personal characteristics (age, gender, level of education) and information about
symptoms of whiplash will be collected (Appendix 8). The following outcome measures will be assessed at
baseline, 14 weeks, 6 months and 12 months (Appendix 9).
5.4.2 Primary outcome
1. Average pain intensity over last week (numerical rating 0-10 scale)22
5.4.3 Secondary outcomes
1. Average pain intensity over last 24 hours (numerical 0 to 10 scale)22
2. Patient’s global impression of recovery (-5 to +5 scale)22
3. Patient-generated measure of disability (Patient-Specific Functional Scale)23
4. Neck-specific measure of disability (Neck Disability Index)24
5. Generic measure of health status (SF-36)25
6. Whiplash-specific measure of disability (Whiplash Disability Questionnaire)26
7. Measures of physical impairment (Cervical range of movement – Appendix 10)27
5.4.3 Effect modifiers
1. Cold pain threshold measured over the cervical spine3 (Appendix 11).
2. Pressure pain threshold measured over the cervical spine and the tibialis anterior3 (Appendix 12).
3. Posttraumatic stress symptoms using the Impact of Events Scale (IES)3.
4. Pain Catastrophising Scale (PCS)
5. Post Traumatic Stress Diagnostic Scale (PDS)
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6.
Self-report Leeds Assessment of Neuropathic Symptoms and Signs pain scale (S-LANSS).
5.4.4 Participant diary
All participants will be assisted to complete an economic cost diary, in addition to this those randomised to
the exercise group will be required to complete a home exercise diary to monitor their compliance with the
exercise program.
Economic cost diary
The economic cost diary (Appendix 14) will be used to identify all the direct and indirect costs associated
with the individual’s whiplash injury as they arise. Direct costs can include healthcare costs, transportation
costs, medication costs and time spent by family members or volunteers providing care. Indirect costs
primarily involve the participant’s lost economic productivity due to poor health.
The collection of economic information will coincide with the 14 week, 6 and 12 month follow up
assessments. At this time, participants will be asked to recall all direct and indirect costs incurred over the
previous two weeks, as a result of their whiplash injury. This method of economic data collection is
consistent with Australian Bureau of Statistics National Health Survey.
The home exercise diary
Those randomised to receive the comprehensive exercise program are expected to complete a home
exercise diary (Appendix 15). The home exercise diary will be used to outline the prescribed exercises as
well as to monitor the compliance with the exercises as the participant will tick the days on which they
complete their program. The treating therapist will assist in the collecting of this data by transposing a copy
of the participant’s compliance into the therapist proforma.
5.4.5 Economic evaluation
Direct costs (e.g. general practitioner, physiotherapy, chiropractor and pharmaceutical services) will be
calculated using schedule consultation fees taken from the Medicare Benefits Schedule, worker’s
compensation schemes and the Pharmaceutical Benefits Scheme. Direct health-care and non-health care
costs which are not captured by these formal schemes will be identified in participant cost diaries.
Participants’ will be assisted to complete cost diaries in order to capture the direct costs; for example, other
professional care, transportation costs and time spent by family members or volunteers providing care. The
indirect costs associated with their injury include the participant’s lost economic productivity due to poor
health. A shadow wage rate will be used to identify the opportunity cost of time spent away from work due
to their injury. These costs will be calculated using income and employment data collected at the baseline
assessment.
Using utility weights derived from participant preferences to health states, the Quality Adjusted Life Years
(QALYs) for each participant will be measured. The two widely used techniques to measure directly the
preferences of individuals are the visual analogue scale and the standard gamble (Appendix 13). These
techniques will be applied to derive upper- and lower-bound estimates of QALYs. These three techniques
for eliciting health preferences – or “utility” weights as they are usually called – have different theoretical
foundations and are also known to be subject to biases of various kinds 28-30. Using more than one of these
methods to derive upper- and lower-bound estimates of QALYs provides an empirical capacity to conduct
sensitivity analyses on the QALY denominator of the Cost-utility Analysis ratio.
5.4.6 Reporting of adverse events
An adverse event (AE) is any untoward medical occurrence in a participant temporally associated with the
trial intervention, whether or not considered related to the trial intervention. Examples of an AE include:
• Exacerbation of a pre-existing condition.
• New conditions detected or diagnosed after enrolment in the trial.
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Examples of an AE do not include anticipated day-to-day fluctuations of pre-existing disease(s) or
condition(s) present or detected at the start of the study that do not worsen.
A serious adverse event (SAE) is one that is life threatening requires inpatient hospitalisation or will result
in persistent or significant disability or incapacity.
All adverse events will be reported to the Adverse Events Committee for the trial (Chris Maher, Michele
Sterling). In NSW, concerns will be addressed to Chris via phone on (02) 9657 0382. In Qld, contact
Michele on (07) 3365 5344. In the unlikely event of a SAE, trial recruitment and treatment should be put on
hold pending advice from the Adverse Events Committee. The Adverse Events Committee will report all
AE and SAE to the relevant ethics committee.
STUDY SEQUENCE
5.5
5.5.1 Telephone screening
• Assess the participants’ eligibility, willingness and ability to participate
• Complete the phone screening assessment forms (Appendix 3)
5.5.2 Baseline Assessment
At the baseline assessment the trial coordinator will ensure the following is completed:
• Participant informed consent form (Appendix 4)
• Contact detail form
• Baseline demographic form
• Questionnaires
– Average pain over the last week (0-10 scale)
– Average pain over the last 24 hours (0-10 scale)
– Global perceived effect (GPE -5 to + 5 scale)
– Neck disability index (NDI)
– SF-36
– Whiplash disability questionnaire (WDQ)
– Impact of Events Scale (IES)
– Pain Catastrophising Scale (PCS)
– Post Traumatic Stress Diagnostic Scale (PDS)
– Self-report Leeds Assessment of Neuropathic Symptoms and Signs pain scale (SLANSS)
– Patient specific functional scale (PSFS)
•
•
•
Cervical spine range of movement assessment (Appendix 10)
Cold pain threshold over the cervical spine (Appendix 11)
Pressure pain threshold measured over the cervical spine and the tibialis anterior (Appendix 12)
5.5.3 Randomisation
Immediately following the baseline assessment participants will be randomised. For all participants an
independent researcher will:
- Select the next envelope in the box and attach it to the competed participant proforma.
- Use the randomisation schedule to allocate the next available participant number.
- Arrange an initial physiotherapy appointment within one week of randomisation. For
participants randomised to receive the educational booklet the initial appointment will be halfhour in duration, for those randomised to receive the comprehensive exercise program the
initial appointment will be one hour in duration.
- The sealed randomisation envelope and the participant proforma will then be sent to the
physiotherapy clinic. The envelope will be opened by the treating physiotherapist and will
serve as a confirmation of group allocation.
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5.5.4 Physiotherapy treatment clinic
Participants assigned to the educational booklet
The initial consultation for participants randomised to receive the educational booklet will be a maximum of
half hour duration. During which the physiotherapist will:
- Provide the participant with the educational booklet
- Give the participant a short period of time to review the booklet
- Discuss and clarify the concepts raised in the booklet
- Show the participant the exercises
Participants in this group will also be able to contact the physiotherapist by phone on two occasions to
clarify the information/exercise contained in the educational booklet.
- Remind the participant of the 14 week, 6 month and 12 month follow up assessments to be
completed at the trial centre.
For participants assigned to the comprehensive exercise program:
The initial consultation for participants randomised to comprehensive exercise program will be a maximum
of one hour duration. During which the physiotherapist will:
- Complete the initial assessment as per the ‘Participant proforma’
- Outline exercises to be completed as part of their home exercise program, making sure a copy of
the exercise prescribed are also recorded in the participant proforma.
- Arrange a follow up appointment, as per frequency set out in the table under 5.3.4.
5.5.5 14 weeks, 6 and 12 month follow up assessments
To be completed by all participants at 14 weeks, 6 and 12 months:
•
Questionnaires
– Average pain over the last week (0-10 scale)
– Average pain over the last 24 hours (0-10 scale)
– Global perceived effect (GPE -5 to + 5 scale)
– Neck disability index (NDI)
– SF-36
– Whiplash disability questionnaire (WDQ)
– Impact of Events Scale (IES)
– Pain Catastrophising Scale (PCS)
– Post Traumatic Stress Diagnostic Scale (PDS)
– Self-report Leeds Assessment of Neuropathic Symptoms and Signs pain scale (SLANSS)
– Patient specific functional scale (PSFS)
•
Adverse effects of treatment (14 week assessment only
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5.6 QUALITY ASSURANCE
The study will be conducted in accordance with the protocol, Manual of Procedures, ICH Guidelines for
Good Clinical Research Practice and with all relevant local ethical regulations.
5.6.1 Monitoring of study sites
Prior to commencement of the study, treatment provider sites will be provided with a copy of the Trial and
Treatment Protocols. Further, the physiotherapists delivering the trial treatments will be trained to deliver
the interventions by experts in the Physiotherapy field. Therapists will be required to sign a clinical trial
agreement form which specifies trial obligations, requirements and payments.
During the trial, regular contact will be made with the treatment provider sites to ensure that the trial is
being conducted according to the protocol and any concerns regarding the implementation of treatment can
be addressed in a timely manner. All Physiotherapists will have an advice and treatment session audited by
one of the investigators (MS, GJ, TR) to ensure that the therapy is of high quality and in accordance with
the protocol.
5.6.2 Data integrity
The integrity of trial data will be monitored by regularly scrutinising data sheets for omissions and errors.
Data will be double entered and the source of any inconsistencies will be explored and resolved.
5.7 STATISTICAL ISSUES
5.7.1 Statistical analysis and methodological considerations
Treatment efficacy variables: We will analyse the effect of treatment separately for each outcome using
linear mixed models with time as a repeated factor. The model will account for correlation over time within
participants, correlation within clinics and potential confounders (e.g. important prognostic factors).
Confounding will be assessed by examining the effect of the potential confounders on the results obtained
from the analyses. Any potential confounder whose inclusion changes the estimated treatment effects by a
clinically relevant amount will be retained as a confounder. We will obtain estimates of the effect of the
intervention by constructing linear contrasts to compare the mean change in outcome from baseline to each
time point between the treatment and control groups, with adjustment for the other variables.
Effect modifiers: Only those variables listed as effect modifiers in Section 5.4.3 will be assessed for effect
modification. This will be done by including a predictor-by-treatment group-by-time interaction term to the
mixed models analyses. Effect modification will only be assessed for the primary outcome of average pain
intensity over the last week.
5.7.2 Sample size
Brookes and colleague’s31 simulations demonstrate that when testing for effect modification, trials have the
same power to detect an interaction effect that is twice the size of the main effect. We argue that small
interaction effects are not clinically significant and we have planned the study with sufficient power to
detect the following clinically important interaction effects: (NB the study can detect main effects half this
size)
• 2.0 units on the 0-10 Pain intensity scale (estimate for SD= 2.0),
• 1.5 units on the 0-10 Patient Specific Functional Scale (estimate for SD = 1.5),
• 30 units on the 0-130 Whiplash Disability Questionnaire (estimate for SD = 30),
• 2.0 units on the -5 to +5 Global perceived effect impression of recovery scale (estimate for SD
2.0),
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•
•
•
6 units on the 0-50 Neck Disability Index (estimate for SD =5.6)
15 points on the 0-100 SF36 physical summary score (estimate for SD =10.0)
15 points on the 0-100 SF36 mental summary score (estimate for SD = 11.0).
We have taken the SD estimates from the previous trials we completed that recruited a similar patient
cohort8 9 and a published study of the Whiplash Disability Questionnaire26. With specifications of alpha
=0.05, power =0.80 and allowing for up to 10% loss to follow-up and 10% treatment non-compliance, a
sample size of 86 participants per group will allow us to detect an interaction effect size equal to 1.0 times
the SD (the smallest interaction effect size we have specified above) and a treatment main effect of 0.5SD.
We understand the study is somewhat overpowered for the main effect of treatment but it is crucial to
adequately power the study for the interaction effect
5.8 INDEMNITY
The George Institute For International Health and the University of Queensland shall at all times indemnify
their study investigators and their staff from claims that may be made against them for any injury sustained
by a study participant as a consequence of effects of the interventions used in the study in accordance with
this protocol provided the ‘Medicines Australia form of Indemnity for Clinical Trials’ has been signed.
5.9 PUBLICATIONS AND REPORTS
The main study results will be submitted for publication in a prominent journal with all actively
collaborating investigators acknowledged. The George Institute Public Affairs and Marketing staff will
ensure that both the conduct and the results of this study are widely and reliably publicised in the general
media, including newspaper, radio talk-back program and TV news items.
Individuals meeting the International Committee of Medical Journal Editors (ICMJE) authorship
requirements1 are eligible for authorship on study publications. Provision of trial treatment does not meet
ICMJE authorship requirements; however trial physiotherapists can elect to be acknowledged in trial
publications.
5.10 FUNDING
The Chronic Whiplash Exercise Trial is funded by a grant from the University of Sydney, University of
Queensland, Motor Accidents Authority New South Wales, Motor Accidents Insurance Commission
Queensland and National Health and Medical Research Council. The study was initiated and designed by
the investigators, independently of The George Institute For International Health, University of
Queensland, Motor Accidents Authority NSW and Motor Accidents Insurance Commission Queensland,
and the data will be collected, analysed and published independently of these parties.
5.11 TIMELINE
1. All participating personnel will be trained for the trial by July 2009.
2. Recruitment of participants will commence at the end of August 2009.
3. 100% of participants will be recruited and treatment completed by December 2010.
4. 100% of 12 month follow-up data collected and entered by December 2011.
5. Data analysis and manuscript completed by May 2012.
1
1) substantial contributions to conception and design, acquisition of data, or analysis and
interpretation of data; 2) drafting the article or revising it critically for important intellectual content;
and 3) final approval of the version to be published. Authors should meet conditions 1, 2, and 3.
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6. References:
1. Dwyer G, Davis S, editors. ACSM's health-related physical fitness assessment manual / American College
of Sports Medicine. Philadelphia: Lippincott Williams & Wilkins, 2005.
2. Rebbeck T, Sindhusake D, Cameron I, Rubin G, Feyer A-M, Walsh J, et al. A prospective cohort study of
health outcomes following whiplash associated disorders in an Australian population. Injury
Prevention 2006; 12:93-86.
3. Sterling M, Jull G, Vicenzino B, Kenardy J, Darnell R. Physical and psychological factors predict outcome
following whiplash injury. Pain 2005; 114(1-2):141-8.
4. Motor Accidents Authority of NSW. Whiplash and the NSW Motor Accidents Scheme. Statistical
Information Paper No 7. Sydney: Motor Accidents Authority of NSW, 1999.
5. Kamper S, Rebbeck T, Maher C, McAuley J, Sterling M. Course and prognostic factors of whiplash: a
systematic review and meta-analysis. Pain 2008; 138: 617-629.
6. Verhagen AP, Scholten-Peeters G, van Wijngaarden S, de Bie RA, Bierma-Zeinstra SMA. Conservative
treatments for whiplash [Systematic Review]. Cochrane Database of Systematic Reviews 2007; 4:4.
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chronic cervical zygapophyseal-joint pain. New England Journal of Medicine 1996; 335(23):1721-6.
8. Stewart MJ, Maher CG, Refshauge KM, Herbert RD, Bogduk N, Nicholas M. Randomized controlled trial
of exercise for chronic whiplash-associated disorders. Pain 2007; 128(1-2):59-68.
9. Jull G, Sterling M, Kenardy J, Beller E. Does the presence of sensory hypersensitivity influence outcomes
of physical rehabilitation for chronic whiplash? - A preliminary RCT. Pain 2007; 129(1-2):28-34.
10. Hayden JA, van Tulder MW, Tomlinson G. Systematic review: strategies for using exercise therapy to
improve outcomes in chronic low back pain. Annals of Internal Medicine 2005; 142(9):776-85.
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Spine 2004; 29(2):182-8.
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27. Hole D, Cook J, Bolton J. Reliability and concurrent validity of two instruments for measuring cervical
range of motion: effects of age and gender. Manual Therapy 1995; 1:36-42.
28. Bleichrodt H. A new explanation for the difference between Time Trade-Off Utilities and Standard
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29. Brazier J. Use of visual analogue scales in economics evaluation. Expert Review of Pharmacoeconomics
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Health Economics 2003; 22(4):659-674.
31. Brookes ST, Whitley E, Peters TJ, Mulheran PA, Egger M, Davey Smith G. Subgroup analyses in
randomised controlled trials: quantifying the risks of false-positives and false-negatives. Health
Technology Assessment 2001; 5(33):1-56.
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CHRONIC WHIPLASH EXERCISE TRIAL PROTOCOL
7. Appendices
APPENDIX 1 – PROMISE ADVERTISEMENT
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APPENDIX 2 – MOTOR ACCIDENTS AUTHORITY LETTER OF INVITATION PARTICIPANT
INFORMATION SHEET
Insert Name
Insert Address
Re: A randomised controlled trial of a comprehensive exercise program for chronic whiplash
I am writing on behalf of the Motor Accidents Authority (MAA) of NSW to invite you to participate in a
physiotherapy research study for the treatment of whiplash. The MAA is the NSW Government department
that oversees all aspects of the Compulsory Third Party (Green Slips) scheme including the number and
type of claims. You have been invited to participate in the research because the MAA claims information
indicates that you have had a whiplash injury in the last 5 years.
The MAA and National Health and Medical Research Council are funding this important research to find
out about the best treatment for chronic whiplash. While there is no clear agreement about what treatments
work best for chronic whiplash, we do know that long term neck pain has many negative effects on
people’s enjoyment of life.
This research will be conducted by experts at the George Institute for International Health, The University
of Sydney, and The University of Queensland. The study consists of a 12-week program that begins with
exercises for the neck and then progresses to exercise for the whole body. The treatments offered by the
study are free.
Your participation in this trial is purely voluntary and be assured that your details will remain confidential
at all times. Participation in the study will not affect your ongoing medical treatment or relationship with
medical staff.
If you are interested in participating or would like further details please contact the George Institute study
coordinator Zoe Michaleff. For your information, we have attached a detailed information sheet about the
study.
Phone: (02) 9657 0321
Fax: (02) 9657 0301
Email: zmichaleff@george.org.au
Yours Sincerely
Carmel Donnelly
A/ General Manager
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Musculoskeletal Division
George Institute for International Health
Level 7, 341 George St, Sydney, NSW
Sydney Medical School
ABN 15 211 513 464
Prof Christopher Maher, PhD
Director, Musculoskeletal Division
The George Institute for International Health
Professor, Sydney Medical School
The University of Sydney
PO Box M201, Missenden Rd
Sydney, NSW 2050
AUSTRALIA
Telephone: +61 2 9657 0382
Facsimile: +61 2 9657 0301
Email: cmaher@george.org.au
A randomised controlled trial of a comprehensive exercise program for chronic whiplash
Sydney Investigators
Prof Chris Maher, A/Prof Jane Latimer, Dr Christine Lin, Dr Trudy Rebbeck, Miss Zoe Michaleff
PARTICIPANT INFORMATION STATEMENT
This study is funded by the Motor Accidents Authority of New South Wales, Motor Accidents Insurance Commission of
Queensland and the National Health and Medical Research Council. Data is being collected in Sydney and Brisbane. The Sydney
site is led by Professor Chris Maher and Associate Professor Jane Latimer of the George Institute for International Health. The
Brisbane site is led by Associate Professor Michele Sterling and Professor Gwen Jull from the University of Queensland.
There are no medical treatments that have been shown to be effective for chronic or persistent whiplash. You are invited to take
part in a research study evaluating physiotherapy treatment of chronic or persistent whiplash. The aim is to investigate the
effectiveness and cost-effectiveness of a comprehensive exercise program for chronic whiplash. The exercise program begins
with exercises for the neck and then progresses to exercise for the whole body. At present we do not know if this program is
helpful for people with chronic whiplash. The only way to find this out is to conduct a randomised controlled trial.
If you agree to participate in this study, you will be requested to complete assessments at enrolment and then 14 weeks, 6 and 12
months later. The assessments comprise of some questionnaires and a physical examination. The first assessment will take one
hour and the follow-ups 30 minutes. You will also need to complete a diary to record your health care costs for whiplash.
Questionnaires
You will be asked to complete a series of questionnaires seeking information on the accident history, current symptoms, any
treatment received to date, compensation status, employment status and weekly income along with time lost from paid
employment and unpaid duties (e.g. home duties). You will also be asked to complete questionnaires relating to how your neck
pain is affecting your daily activities and in what way your neck pain is affecting you personally.
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Physical Examination
The physical examination will provide information about how the joints, muscles and nerves in your neck and upper body are
working. Throughout the physical testing procedures, any pain experienced will be constantly monitored and you will be asked to
record its level on a scale of 1 to 10. All testing procedures will be explained to you in greater detail just prior to being performed.
A summary is provided below.
The following physical tests will be performed:
• Your neck movements will be tested and this simply requires you to move your head through its normal range of movement.
We will place an inclinometer next to your head to measure the range of movement.
• Pressure algometry will be performed. This involves the application of a small pressure sensor to various regions on your
neck and limbs. The pressure is gradually increased until the moment you first perceive it to be painful, upon which you press a
button and the test will cease. No tissue damage will occur at this low intensity. Any local soreness should ease rapidly.
• Cold pain thresholds will be measured. This involves the application of a small thermode (element) to various regions on
your neck and limbs. The temperature of the thermode will decrease until the moment when you perceive it to be painful, upon
which you will press a button and the test will cease. The test will be then repeated three times, and then will be done using a heat
stimulus instead of cold. The thermode has both upper and lower safety cut-off points to ensure that no tissue damage will occur.
An occasional side effect of such a thorough examination could be a temporary flare-up of your usual symptoms, but this should
settle. Don’t hesitate to take your normal medication if warranted after the assessment.
All participants will be provided with an educational booklet on whiplash. The booklet provides information about whiplash,
provides advice on how to manage symptoms of whiplash and explains and illustrates an exercise program for whiplash. This is
the standard way people with chronic whiplash are managed. You will then be randomly assigned to either the exercise or booklet
group. Participants in the exercise group will be asked to attend 20 one-hour treatments over a 12-week period delivered at
physiotherapy clinics by trained personnel. Participants in the booklet group will receive one physiotherapy consultation and up to
two telephone calls to the physiotherapist to review the educational booklet, you do not need to attend for additional treatment.
All aspects of the study, including results, will be strictly confidential and only the investigators named above will have access to
information on participants. Should documents be subpoenaed, researchers are bound by law to produce them. A report of the
study may be submitted for publication, but individual participants will not be identifiable in such a report.
Participation in this study is entirely voluntary: you are not obliged to participate and - if you do participate - you can withdraw at
any time without prejudice or penalty. Whatever your decision, it will not affect your medical treatment or your relationship with
medical staff.
When you have read this information, the research assistant will discuss it with you further and answer any questions you may
have. If you would like to know more at any stage, please feel free to contact Dr Christine Lin (8238 2437). This information
sheet is for you to keep.
Any person with concerns or complaints about the conduct of a research study can contact the Senior Ethics Officer,
Ethics Administration, University of Sydney on (02) 9351 4811 (Telephone); (02) 9351 6706 (Facsimile) or
gbriody@usyd.edu.au (Email).
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CHRONIC WHIPLASH EXERCISE TRIAL
APPENDIX 3 – PHONE SCREENING
TELEPHONE SCREENING FORM
NAME: _________________________________
DATE OF CONTACT: __________________________
INCLUSION (must respond YES to the following)
•
Is your neck pain a result of a MVA?
Y/N
•
Was the MVA 3 – 5 years ago?
Y/N
Date of injury: ______________________________
•
Are you aged between 18 and 65 years?
Y/N
•
Are you able to attend 4 assessment sessions at the trial centre over 12 months? (Sydney: The George Institute For
International Health; Brisbane: UQ RBWH Lab)
•
Y/N
Are you fluent in spoken and written English?
Y/N
Ask the participant the most appropriate response to the following questions relating to their neck pain.
•
How much neck pain have you had during the past four weeks?
no neck pain
very mild
mild
moderate
severe
very severe
•
During the past four weeks, how much did your neck pain interfere with your normal work (including both work
outside the home and housework)?
not at all
a little bit
moderately
quite a bit
extremely
(**NB participants must rate their pain as moderate to high in one or both questions)
•
Numerical rating scale: 0 = no pain, 10 = worst imaginable pain.
___/10
EXCLUSION (must respond NO to all)
•
Are you currently receiving any other care for whiplash besides seeing the GP?
•
Did you suffer a head injury, fractures or dislocations at the time of the injury (WAD IV)? Y / N
•
Do you have any other medical condition affecting your spine (e.g. metastatic, inflammatory or infective disease of the
spine)?
•
Y/N
Y/N
Do you have any weakness or altered sensation in the arm(s) beyond the shoulder?
If yes, the participant will require a neurological examination at the lab assessment (tick)
•
Y/N
Have you had spinal surgery in the past 12 months?
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Y/N
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CHRONIC WHIPLASH EXERCISE TRIAL
Physical Activity Readiness Questionaire (PAR-Q)
• Has your doctor ever said that you have a heart condition or that you should only do physical activity recommended by a
doctor?
Y/N
•
Do you feel pain in your chest when you do physical activity?
Y/N
•
In the past month, have you had chest pain when you were not doing physical activity?
Y/N
•
Do you lose your balance because of dizziness or do you ever lose consciousness?
Y/N
•
Do you have a bone or joint problem that could be made worse by a change in physical activity?
Y/N
•
Is you doctor currently prescribing drugs (for example water pills) for your blood pressure or heart condition?
Y/N
•
Do you know of any other reason why you should NOT do physical activity?
Y/N
(Yes in response to any of the above questions may result in either exclusion OR a review at the trial centre to clarify responses)
Make the patient aware that:
All participants will receive evidence-based physiotherapy exercise treatment, but they will receive either:
1) The educational booklet in addition to one advice session with a physiotherapist. Exercises will self managed and guided by the
educational booklet. You will have access to contact the physiotherapist on two occasions if required. OR
2) The educational booklet in addition to 20 sessions with a physiotherapist over 12 weeks and be guided through the exercises.
(Encourage the participants to appreciate that group 1 are not ‘hard-done by’, there are benefits to being in both groups!)
The study runs for twelve months and involves:
• Attending the trial centre for an initial assessment (Sydney: The George Institute For International Health; Brisbane: UQ
RBWH Lab). This will involve sensory tests ROM and questionnaires, under the guidance of a physiotherapist. None of the
tests are painful.
• Follow up assessments completed at 14 weeks, 6 and 12 months after randomisation and will include the same measures as
the initial assessment.
• Maintaining a diary for the 12 month period of health related costs (practitioner costs, medication) related to the whiplash
injury.
• No personal financial cost for the participant, however they will be reimbursed for travelling costs (up to $60) each time they
attend the laboratory for assessment.
Has the participant agreed to participate?
Y/N
If yes, initial appointment date/time: ___________________
Contact details:
Address: ______________________________________________________________________________
Phone: _________________________________
DOB: ____/____/____
Mobile: _______________________________
Gender: M / F
E-mail: ________________________________________________________________________________
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APPENDIX 4 – PARTICIPANT WRITTEN CONSENT FORM
Musculoskeletal Division
George Institute for International Health
Level 7, 341 George St, Sydney, NSW
Sydney Medical School
ABN 15 211 513 464
Prof Christopher Maher, PhD
Director, Musculoskeletal Division
The George Institute for International Health
Professor, Sydney Medical School
The University of Sydney
PO Box M201, Missenden Rd
Sydney, NSW 2050
AUSTRALIA
Telephone: +61 2 9657 0382
Facsimile: +61 2 9657 0301
Email: cmaher@george.org.au
A randomised controlled trial of a comprehensive exercise program for chronic whiplash
PARTICIPANT CONSENT FORM
I, ............................................................................................................................................................... [name]
have read and understood the information for participants on the above named research study and have
discussed it with the researcher/s.
I am aware of the procedures involved in the study, including any inconvenience, risk, discomfort or side
effect, and of their implications.
I freely choose to participate in this study and understand that I can withdraw without compromise at any
time.
I also understand that the research study is strictly confidential however should documents be subpoenaed,
researchers are bound by law to produce them.
I hereby agree to participate in this research study.
Signature: ...........................................................................................................................................................
Name:..................................................................................................................................................................
Date:....................................................................................................................................................................
Investigator’s signature:
......................................................................................................
Investigator’s name: ..........................................................................................................................................
Date:....................................................................................................................................................................
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APPENDIX 5 – NEUROLOGICAL EXAMINATION
CHRONIC WHIPLASH EXERCISE TRIAL
TRIAL CENTRE SCREENING
Review PHONE SCREENING
Neurological examination required? YES
Participant name
___________________
Date:
___________________
NO
NEUROLOGICAL EXAMINATION
MUSCLE STRENGTH
LEFT
RIGHT
C4 (sh. elevation)
C5 (sh. abd)
C6 (elbow flexors)
C7 (elbow extensors)
C8 (wrist extensors)
T1 (finger abd)
SENSATION
Light touch
L=R
L<R
Sharp/blunt discrimination (if req) :
Dermatomal distribution YES
L>R
NO
REFLEXES
L=R
L=R
Biceps
Triceps
ELIGIBLE
SIGNED CONSENT obtained
Proceed to baseline questionnaires
INELIGIBLE
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CHRONIC WHIPLASH EXERCISE TRIAL PROTOCOL
APPENDIX 6 – TELEPHONE SCRIPT TO ARRANGE FOLLOW-UP ASSESSMENTS
Script for phone call to set date and time for follow-ups
• Phone participant
• Ask to speak to participant
• Greet participant and thank them for their participation to date
• State that their next follow-up is due and offer them some times to choose from
Once a mutually convenient time is agreed thank the participant and state that you will send them a letter
confirming details and will make a reminder telephone call to them 24hrs prior to the appointment
Script for 24hour phone call reminder
• Phone participant
• Ask to speak to participant
• Greet participant and thank them for their participation to date
• Remind them of their agreed appointment and confirm that they are still able to attend.
• If appointment confirmed thank them and conclude call
• If unable to attend organise an alternate time. Thank the participant and state that you will send them a
letter confirming details and will ring them 24hrs prior to appointment.
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APPENDIX 7 – LETTER CONFIRMING APPOINTMENT
Musculoskeletal Division
George Institute for International Health
Level 7, 341 George St, Sydney, NSW
Sydney Medical School
ABN 15 211 513 464
Prof Christopher Maher, PhD
Director, Musculoskeletal Division
The George Institute for International Health
Professor, Sydney Medical School
The University of Sydney
PO Box M201, Missenden Rd
Sydney, NSW 2050
AUSTRALIA
Telephone: +61 2 9657 0382
Facsimile: +61 2 9657 0301
Email: cmaher@george.org.au
A randomised controlled trial of a comprehensive exercise program for chronic whiplash
<Participants name>
<Participants address>
CONFIRMATION OF FOLLOW UP APPOINTMENT
Dear <name>,
Thank you for your contribution to the Chronic Whiplash Exercise Trial. As discussed by phone your next
follow-up appointment is <insert date & time> at The George Institute For International Health, Level 7,
341 George St, Sydney.
If you have a change of circumstances and cannot make this appointment please contact me immediately
and I will reschedule the appointment.
Regards
Zoe Michaleff
Trial Coordinator
Ph: (02) 9657 0321
Mob: 0400 369 348
Email: zmichaleff@george.org.au
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APPENDIX 8 – BASELINE DEMOGRAPHIC DETAILS FORM
Chronic Whiplash Exercise Trial
- Initial Assessment
Participant’s Initials
Participant Number
Date
_____/_____/_____
CONFIDENTIAL INFORMATION
Please be assured that the information asked on this form will remain confidential at all times. It is
collected for statistical purposes only.
1.
Working Status:
Employed (Occupation _______________________)
Self Employed (Occupation ____________________)
Home Duties
Unemployed
Retired
Entitled leave (long service, maternity, sick leave)
Student
2.
If employed/self employed, are you:
Currently working usual hours
Working reduced hours due to whiplash injury
IF REDUCED, indicate percentage of usual hours ______%
Not working due to whiplash injury
3. Please indicate your gross (i.e., pre-tax) income by ticking a box.
Your income may be entered as either ‘gross annual income’ or ‘gross weekly income’.
Gross Annual Income
Nil Income
$1 - $9,999
$10,000 - $19,999
$20,000 - $29,999
$30,000 - $39,999
$40,000 - $49,999
$50,000 - $59,999
$60,000 - $69,999
$70,000 - $79,999
$80,000 - $89,999
$90,000 - $99,999
$100,000 - $109,999
$110,000 - $119,999
$120,000 - $129,999
$130,00 - $139,999
$140,000 - $149,999
≥ $150,000
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Gross Weekly Income
$1 - $191 per week
$192 - $384
$385 - $577
$578 - $768
$769 - $961
$962 - $1,153
$1,154 - $1,345
$1,346 - $1,537
$1,538 - $1,730
$1,731 - $1,922
$1,923 - $2,114
$2,115 - $2,307
$2,308 - $2,499
$2,500 - $2,691
$2,692 - $2,884
≥ $2,885
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APPENDIX 8 – BASELINE DEMOGRAPHIC DETAILS FORM
Chronic Whiplash Exercise Trial
- Initial Assessment
4.
Participant’s Initials
Participant Number
_____/_____/_____
Date
Education:
Please indicate the highest grade you completed at school: _____________________
Please list any further qualifications and/or trades you have gained since leaving school, including
their full-time duration:
5.
Qualification 1:
Length of course
Qualification 2:
Length of course
Qualification 3:
Length of course
Qualification 4:
Length of course
Have you lodged a compensation claim for this injury: Yes
No
If yes
Please select what type of compensation claim:
CTP Workers Compensation Other (please list) ______________________
Has your claim been settled?
6.
Yes
No
Have you engaged the services of a solicitor with respect to your whiplash injury?
Yes
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No
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APPENDIX 8 – BASELINE DEMOGRAPHIC DETAILS FORM
Chronic Whiplash Exercise Trial
- Initial Assessment
Participant’s Initials
Participant Number
Date
_____/_____/_____
PERSONAL DETAILS
Title:
Name:
D.O.B.:
Gender: M / F
(Please circle)
Address:
Postcode:
Phone (H):
Phone (W):
Mobile:
Email:
Please fill in the contact details for 2 people (a relative, and a friend) who are not living with you. This
information is only to be used to help us to find you if we lose contact.
Name:
Relationship:
Address:
Postcode:
Phone (H):
Phone (W):
Mobile:
Email:
Name:
Relationship:
Address:
Postcode:
Phone (H):
Phone (W):
Mobile:
Email:
Please fill in the contact details for your regular GP below:
GP Name:
Phone
Address:
Postcode:
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APPENDIX 8 – BASELINE DEMOGRAPHIC DETAILS FORM
Participant’s Initials
Chronic Whiplash Exercise Trial
- Initial Assessment
Participant Number
_____/_____/_____
Date
ACCIDENT HISTORY
Date of Accident:
_____/_____/_____
1.
At the time of the accident were you:
The driver
The front seat passenger
A back seat passenger
Riding a motorbike
2.
Did you know the accident was coming? Yes
3.
For the vehicle you were in was the collision:
Rear end
Rear and front end
Front end
Side impact
4.
Was the vehicle you were in stationary at the time of impact? Yes
No
EVENTS FOLLOWING ACCIDENT
1. Following the car accident, did your neck pain start:
No
Immediately
Within 24 hours
After 24 hours
2.
Was your neck movement restricted following the accident? Not at all
Mildly
Moderately
Severely
3.
Did the restriction in movement start:
Immediately
Within 24 hours
After 24 hours
4.
Did you lose consciousness immediately after the accident?
5.
Were you admitted to hospital after the accident?
Yes
Yes
No
Yes
No
No
MEDICAL HISTORY
1.
Have you had any major surgery or other injuries?
If YES – Please give details: __________________________________________________
__________________________________________________________________________________
__________________________________________________________________
2.
Do you suffer from any other medical conditions?
Yes
No
If YES – Please give details: __________________________________________________
__________________________________________________________________________________
__________________________________________________________________
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APPENDIX 8 – BASELINE DEMOGRAPHIC DETAILS FORM
Chronic Whiplash Exercise Trial
- Initial Assessment
3.
Participant’s Initials
Participant Number
Date
_____/_____/_____
Have any of the following investigations been performed for your neck pain?
Yes, please indicate the investigations you have had and any significant findings below
No, please proceed to question 4
X-ray – Significant findings
NO
YES Please give details:
______________________________________________________________________________________
___________________________________________________________________
CT – Significant findings NO
YES Please give details:
______________________________________________________________________________________
____________________________________________________________________
MRI – Significant findings NO
YES Please give details:
______________________________________________________________________________________
____________________________________________________________________
4.
What treatments have you received for your neck pain since your accident?
Type of treatment
Number of sessions (Approximately)
Physiotherapy
_______
Chiropractic
_______
Massage
_______
Acupuncture
_______
Other: _____________________
_______
Other: _____________________
_______
Surgical procedures
SYMPTOMS
Please mark on the body chart below where you feel pain or any other symptoms e.g. pins and
needles or numbness.
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CHRONIC WHIPLASH EXERCISE TRIAL PROTOCOL
APPENDIX 9 – OUTCOME ASSESSMENTS
PRIMARY OUTCOME MEASURE
AVERAGE PAIN INTENSITY OVER THE LAST WEEK
Rate your pain on a scale from 0 to 10 where 0 represents no pain and 10 is the worst pain possible. Please
circle the number which best describes your average pain over the past week.
0
No
Pain
1
2
3
4
5
6
7
8
9
10
Worst
possible
pain
SECONDARY OUTCOME MEASURES
AVERAGE PAIN INTENSITY OVER THE LAST 24 HOURS
Rate your pain on a scale from 0 to 10 where 0 represents no pain and 10 is the worst pain possible. Please
circle the number which best describes your average pain over the past 24 hours.
0
No
Pain
1
2
3
4
5
6
7
8
9
10
Worst
possible
pain
GLOBAL PERSEVERD EFFECT (GPE)
With respect to your whiplash injury, compared to when you entered the study, how would you describe
yourself these days? (circle the most appropriate)
-5
Vastly
Worse
-4
-3
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-2
-1
0
Unchanged
1
2
3
4
5
Completely
Recovered
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NECK DISABILITY INDEX (NDI)
INSTRUCTIONS: This questionnaire is designed to enable us to understand how much your neck pain has affected your ability to manage everyday activities. Please answer
each question by ticking () ONE CHOICE that most applies to you. We realise that you may feel that more than one statement may relate to you, but PLEASE JUST TICK
() THE ONE CHOICE, WHICH CLOSELY DESCRIBES YOUR PROBLEM RIGHT NOW.
4. READING
8. DRIVING (omit this question if you never drive a
I can read as much as I want to with no pain in my
car
when in good health)
neck.
1. PAIN INTENSITY
I
can drive my car without neck pain.
I can read as much as I want with slight pain in my
I have no pain at the moment.
I can drive my car as long as I want with slight pain
neck.
The pain is mild at the moment.
in my neck.
I can read as much as I want with moderate pain in
I can drive my car as long as I want with moderate
The pain comes and goes and is moderate.
my neck.
pain in my neck.
The pain is moderate and does not vary much.
I cannot read as much as I want because of
I cannot drive my car as long as I want because of
moderate pain in my neck.
The pain is severe but comes and goes.
moderate
pain in my neck.
I cannot read as much as I want because of severe
The pain is severe and does not vary much.
I can hardly drive my car at all because of severe
pain in my neck.
pain in my neck.
I cannot read at all.
I cannot drive my car at all.
5. HEADACHE
I have no headaches at all.
2. PERSONAL CARE
9. NECK PAIN AND SLEEPING
I have slight headaches which come infrequently.
I can look after myself without causing extra pain.
I have no trouble sleeping.
I have moderate headaches which come
I can look after myself normally but it causes extra
My sleep is slightly disturbed (less than 1 hour
infrequently.
pain.
sleepless).
I have moderate headaches which come frequently.
It is painful to look after myself and I am slow and
My sleep is mildly disturbed (1-2 hours sleepless).
I have severe headaches which come frequently.
careful.
My sleep is moderately disturbed (2-3 hours
I have headaches almost all the time.
I need some help, but manage most of my personal
sleepless).
care.
My sleep is greatly disturbed (3-5 hours sleepless).
6. CONCENTRATION
I need help every day in most aspects of self-care.
My sleep is completely disturbed (5-7 hours
I can concentrate fully when I want to with no
sleepless).
I do not get dressed, I wash with difficulty and stay
difficulty.
in bed.
I can concentrate fully when I want to with slight
3. LIFTING
10. RECREATION
difficulty.
I can lift heavy objects without extra pain
I am able to engage in all recreational activities with
I have a fair degree of difficulty concentrating when
I can lift heavy objects but it causes extra pain
no
pain in my neck at all.
I want to.
Pain prevents me from lifting heavy objects off the
I
am able to engage in all recreational activities with
I have a lot of difficulty concentrating when I want
floor, but I can if they are conveniently positioned, for
some
pain in my neck.
to.
example on a table.
I
am
able to engage in most, but not all recreational
I have a great deal of difficulty concentrating when
Pain prevents me from lifting heavy objects, but I
activities
because of pain in my neck.
I want to.
can manage light to medium weights if they are
I am able to engage in a few of my usual
I cannot concentrate at all.
conveniently positioned.
recreational activities because of pain in my neck.
I can lift very light weights.
I can hardly do any recreational activities because
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I cannot lift or carry anything at all.
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of pain in my neck.
I cannot do any recreational activities at all.
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SF-36 (Generic measure of health status)
This questionnaire asks for your views about your health, how you feel and how well you are able to do your
usual activities.
Answer each question by marking the answer as indicated. If you are unsure about how to answer a question,
please give the best answer you can.
1.
2.
3.
In general, would you say your health is:
Excellent
Very good
Good
Fair
Poor
Compared to one year ago, how would you rate your health in general now?
Much better than one year ago
Somewhat better than one year ago
About the same as one year ago
Somewhat worse than one year ago
Much worse than one year ago.
The following are about activities you might do during a typical day. Does your health limit you in
these activities? If so, how much?
Yes, limited
a lot
Yes, limited
a little
No, not
limited at all
Vigorous activities, such as running, lifting heavy objects,
participating in strenuous sports
Moderate activities, such as moving a table, pushing a
vacuum cleaner, bowling or playing golf
Lifting or carrying groceries
Climbing several flights of stairs
Climbing one flight of stairs
Bending, kneeling or stooping
Walking more than one kilometre
Walking half a kilometre
Walking 100 metres
Bathing or dressing yourself
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4.
During the past 4 weeks, have you had any of the following problems with your work or other
regular daily activities as a result of your physical health?
Yes
No
Cut down the amount of time you spent on work or other activities
Accomplished less than you would like
Were limited in the kind of work or other activities
Had difficulty performing the work or other activities (for example, it took extra
effort)
5.
During the past 4 weeks, have you had any of the following problems with your work or other
regular daily activities as a result of any emotional problems (such as feeling depressed or
anxious)?
Yes
No
Cut down the amount of time you spent on work or other activities
Accomplished less than you would like
Didn't do work or other activities as carefully as usual
6.
7.
8.
During the past 4 weeks, to what extent has your physical health or emotional problems interfered
with normal social activities with family, friends, neighbours, or groups?
Not at all
Slightly
Moderately
Quite a bit
Extremely
How much bodily pain have you had during the past 4 weeks?
No bodily pain
Very mild
Mild
Moderate
Severe
Very severe
During the past 4 weeks, how much did pain interfere with your normal work (including both
work outside the home and housework)?
Not at all
A little bit
Moderately
Quite a bit
Extremely
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9.
These questions are about how you feel and how things have been with you during the past 4
weeks. For each question, please give the one answer that comes closest to the way you have been
feeling.
How much of the time during the past 4 weeks:
All of
the time
Most of
the time
A good
bit of
the time
Some of
the time
A little
of the
time
None of
the time
Did you feel full of life?
Have you been a very nervous person?
Have you felt so down in the dumps that
nothing could cheer you up?
Have you felt calm and peaceful?
Did you have a lot of energy?
Have you felt down?
Did you feel worn out?
Have you been a happy person?
Did you feel tired?
10. During the past 4 weeks, how much of the time has your physical health or emotional problems
interfered with your social activities (like visiting friends, relatives, etc.)?
All of the time
Most of the time
Some of the time
A little of the time
None of the time.
11. How TRUE or FALSE is each of the following statements for you?
Definitely
true
Mostly
true
Don't
know
Mostly
false
Definitely
false
I seem to get sick a little easier than other
people
I am as healthy as anybody I know
I expect my health to get worse
My health is excellent
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WHIPLASH DISABILITY QUESTIONNAIRE (WDQ)
This questionnaire has been designed to provide information on the impact that your whiplash injury and
symptoms have upon your lifestyle.
Please circle a number in each section to indicate how you have been affected by the whiplash injury and
symptoms. If one or more questions are not relevant to you (e.g. you don’t participate in sporting activities),
please indicate this by writing N/A next to the question.
1.
0
No
Pain
How much pain do you have today?
1
2.
0
Not at all
3.
0
Not at all
4.
0
Not at all
5.
0
Not at all
6.
0
Not at all
7.
0
Not at all
2
3
4
5
6
7
8
9
10
Worst
possible
pain
Do your whiplash symptoms interfere with your personal care (washing, dressing etc.)?
1
2
3
4
5
6
7
8
9
10
Unable to
perform
8
9
10
Unable to
perform
Do your whiplash symptoms interfere with your work/home/study duties?
1
2
3
4
5
6
7
Do your whiplash symptoms interfere with driving or using public transport?
1
2
3
4
5
6
7
8
9
10
Unable to travel
in car/use public
transport perform
6
7
8
9
10
Cannot
sleep
7
8
9
10
Always
7
8
9
10
Unable to
socialise
Do your whiplash symptoms interfere with sleep?
1
2
3
4
5
Do you feel more tired/fatigued than usual since your injury?
1
2
3
4
5
6
Do your whiplash symptoms interfere with social activity?
1
2
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3
4
5
6
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8.
0
Not at all
9.
0
Not at all
Do your whiplash symptoms interfere with sporting activity?
1
2
3
4
5
6
7
8
9
10
Unable to
participate
8
9
10
Unable to
participate
8
9
10
Always
8
9
10
Always
8
9
10
Always
9
10
Unable to
concentrate
Do your whiplash symptoms interfere with non-sporting leisure activity?
1
2
3
4
5
6
7
10. Do you experience sadness/depression as a result of your whiplash injury/symptoms?
0
Not at all
1
2
3
4
5
6
7
11. Do you experience anger as a result of your whiplash injury/symptoms?
0
Not at all
1
2
3
4
5
6
7
12. Do you experience anxiety as a result of your whiplash injury/symptoms?
0
Not at all
1
2
3
4
5
6
7
13. Do you have difficulty concentrating as a result of your whiplash injury/symptoms?
0
Not at all
1
2
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3
4
5
6
7
8
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IMPACT OF EVENTS SCALE (IES)
On ____________________________________ you experienced a motor vehicle accident.
Below is a list of comments made by people after stressful life events. Please check each item, indicating how
frequently these comments were true for you DURING THE PAST SEVEN DAYS. If they did not occur
during that time please mark the ‘NOT AT ALL ‘column.
1.
I thought about it when I didn’t mean to.
Not at all
Rarely
Sometimes
Often
2.
I avoided letting myself get upset when I thought
about it or was reminded of it.
Not at all
Rarely
Sometimes
Often
3.
I tried to remove it from memory.
Not at all
Rarely
Sometimes
Often
4.
I had trouble falling asleep or staying asleep
because pictures or thoughts about it came into
my mind.
Not at all
Rarely
Sometimes
Often
5.
I had waves of strong feelings about it.
Not at all
Rarely
Sometimes
Often
6.
I had dreams about it.
Not at all
Rarely
Sometimes
Often
7.
I stayed away from reminders about it.
Not at all
Rarely
Sometimes
Often
8.
I felt as if it hadn’t happened or it wasn’t real.
Not at all
Rarely
Sometimes
Often
9.
I tried not to talk about it.
Not at all
Rarely
Sometimes
Often
10. Pictures about it popped into my mind.
Not at all
Rarely
Sometimes
Often
11. Other things kept making me think about it.
Not at all
Rarely
Sometimes
Often
12. I was aware that I still had a lot of feelings about it
but I didn’t deal with them.
Not at all
Rarely
Sometimes
Often
13. I tried not to think about it.
Not at all
Rarely
Sometimes
Often
14. Any reminder brought back feelings about it.
Not at all
Rarely
Sometimes
Often
15. My feelings were kind of numb.
Not at all
Rarely
Sometimes
Often
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PAIN CATASTROPHISING SCALE (PCS)
Everyone experiences painful situations at some point in their lives. Such experiences may include headaches,
tooth pain, joint or muscle pain. People are often exposed to situations that may cause pain such as illness,
injury dental procedures or surgery.
We are interested in the types of thoughts and feelings that you have when you are in pain. Listed below are
thirteen statements describing different thoughts and feelings that may be associated with pain.
Using the following scale, please indicate the degree to which you have these thoughts and feelings when you
are experiencing pain.
RATING
0
1
2
3
4
MEANING
Not at all
To a slight
degree
To a moderate
degree
To a great
degree
All the time
Number
Statement
Rating
1
I worry all the time about whether the pain will end.
2
I feel I can’t go on.
3
It’s terrible and I think it’s never going to get any better.
4
It’s awful and I feel that it overwhelms me.
5
I feel I can’t stand it anymore.
6
I become afraid that the pain will get worse.
7
I keep thinking of other painful events.
8
I anxiously want the pain to go away.
9
I can’t seem to keep it out of my mind.
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10
I keep thinking about how much it hurts.
11
I keep thinking about how badly I want the pain to stop.
12
There’s nothing I can do to reduce the intensity of the pain.
13
I wonder whether something serious may happen.
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POST TRAUMATIC STRESS DIAGNOSTIC SCALE (PDS)
PART 1
Below are several questions about your motor vehicle accident.
How long ago did the accident happen? 15 Less than 1 month
1 to 3 months
3 to 6 months
6 months to 3 years
3 to 5 years
More than 5 years
During the accident:
Were you physically injured? 16
Y N
Was someone else physically injured? 17
Y N
Did you think your life was in danger? 18
Y N
Did you think that someone else’s life was in danger? 19 Y N
Did you feel helpless? 20
Y N
Did you feel terrified? 21
Y N
PART 2
Below is a list of problems that people sometimes have after experiencing a traumatic event. Read each one
carefully and choose the answer (0-3) that best describes how often that problem has bothered you IN THE
PAST MONTH. Rate each problem with respect to the motor-vehicle accident (the ‘traumatic event’).
O = Not at all or only one time
1 = Once a week of less/once in a while
2 = 2 to 4 times a week/half the time
3 = 5 or more times a week/almost always
Having upsetting thoughts or images about the traumatic event that came into your head
when you didn’t want them to 22
0
1
2
3
Having bad dreams or nightmares about the traumatic event 23
0
1
2
3
Reliving the traumatic event, acting or feeling as if it was happening again 24
0
1
2
3
Feeling emotionally upset when you were reminded of the traumatic event (for example,
feeling scared, angry, sad, guilty, etc.) 25
0
1
2
3
Experiencing physical reactions when you were reminded of the traumatic event (for
example, breaking out in a sweat, heart beating fast) 26
0
1
2
3
Trying not to think about, talk about, or have feelings about the traumatic event 27
0
1
2
3
Trying to avoid activities, people, or places that remind you of the traumatic event
0
1
2
3
Not being able to remember an important part of the traumatic event 29
0
1
2
3
Having much less interest or participating much less often in important activities 30
0
1
2
3
Feeling distant or cut off from people around you 31
0
1
2
3
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Feeling emotionally numb (for example, being unable to cry or unable to have loving
feelings) 32
0
1
2
3
Feeling as if your future plans or hopes will not come true (for example, you will not have
a career, marriage, children, or a long life) 33
0
1
2
3
Having trouble falling asleep 34
0
1
2
3
Feeling irritable or having fits of anger 35
0
1
2
3
Having trouble concentrating (for example, drifting in and out of conversations, losing
track of a story on television, forgetting what you read) 36
0
1
2
3
Being overly alert (for example, checking to see who is around you, being uncomfortable
with your back to a door, etc.) 37
0
1
2
3
Being jumpy or easily startled (for example, when someone walks up behind you)
0
1
2
3
How long have you experienced the problem that you reported above? (Mark only ONE) 39
Less than 1 month
1 to 3 months
More than 3 months
How long after the accident did these problems begin? (Mark only ONE) 40
Less than 6 months
6 or more months
PART 3
Indicate if the problems you rated in Part 2, above, have interfered with any of the following areas of your life
DURING THE PAST MONTH. Select either Yes or No.
Work 41
Y N
Household chores and duties42
Y N
Relationships with friends43
Y N
Fun and leisure activities44
Y N
Schoolwork45
Y N
Relationships with your family46
Sex life47
Y N
Y N
General satisfaction with life48
Y N
Overall level of functioning in all areas of your life49 Y N
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SELF-REPORT LEEDS ASSESSMENT OF NEUROPATHIC SYMPTOMS AND SIGNS PAIN
SCALE (S-LANSS)
Leeds Assessment of Neuropathic Symptoms and Sign (self complete)
Think about how your pain that you showed in the diagram has felt over the last week. Please tick the
descriptions that best match your pain. These descriptions may, or may not, match your pain no matter how
severe it feels.
1.
In the area where you have pain, do you also have ‘pin and needles’, tingling or prickling
sensations?
NO – I don’t get the sensations
YES – I do get these sensations
2.
Does the painful area change colour (perhaps looks mottled or more red) when the pain is
particularly bad?
NO – The pain does not affect the colour of my skin
YES – I have noticed that the pain does make my skin look different from normal
3.
Does your pain make the affected skin abnormally sensitive to touch? Getting unpleasant
sensations or pain when lightly stroking the skin might describe this.
NO – The pain does not make my skin in that area abnormally sensitive to touch
YES – My skin in that area is particularly sensitive to touch
4.
Does your pain come on suddenly and in bursts for no apparent reason when you are completely
still? Words like ‘electric shocks’, jumping and bursting might describe this.
NO – My pain doesn’t really feel like this
YES – I get these sensations often
5. In the area where you have pain, does your skin feel unusually hot like a burning pain?
NO – I don’t have burning pain
YES – I get these sensations often
Gently rub the painful area with your index finger and then rub a non-painful area (for example,
an area of skin further away or on the opposite side from the painful area). How does this rubbing
feel in the painful area?
The pain area feels no different from the non-painful area.
I feel discomfort, like pins and needle, tingling or burning in the painful area that is different from the
non-painful area.
6.
7.
Gently press on the painful area with your finger then gently press in the same way onto a nonpainful area (the same non-painful area that you chose in the last question). How does this feel in
the painful area?
The pain area feels no different from the non-painful area.
I feel numbness or tenderness in the painful area that is different from the non-painful area.
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PATIENT SPECIFIC FUNCTIONAL SCALE (PSFS)
In the spaces provided below, please identify three important activities that you are unable to do or are
having difficulty with as a result of your whiplash injury. The activities you choose should be of varying
difficulty, that is, try and identify an activity that you have a small amount of difficulty doing as a result of
your whiplash injury, moderate amount of difficulty and finally an activity you are finding quite difficult to
do as a result of you whiplash injury.
Below each activity that you have chosen, please circle a number to indicate how well you feel you are able to
perform that activity at this time.
Please try and provide as much information as possible when describing your pre-injury activity e.g. include
the duration or distance you were able to do an activity for prior to your whiplash injury.
Activity 1: _____________________________________________________________________________
_____________________________________________________________________________
0
Unable to
perform
the activity
1
2
3
4
5
6
7
8
9
10
Able to perform
activity at
pre-injury level
Activity 2: _____________________________________________________________________________
_____________________________________________________________________________
0
Unable to
perform
the activity
1
2
3
4
5
6
7
8
9
10
Able to perform
activity at
pre-injury level
Activity 3: _____________________________________________________________________________
_____________________________________________________________________________
0
Unable to
perform
the activity
1
2
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3
4
5
6
7
8
9
10
Able to perform
activity at
pre-injury level
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PHYSICAL EXAMINATION – RANGE OF MOTION
Cervical Range of Motion
Movement
Range
Flexion
Extension
Rotation Right
Rotation Left
Comments:
________________________________________________________________________________________
______________________________________________________________________
Pressure Pain Thresholds
Left
1
2
Right
3
1
2
3
Tibialis Anterior
Spinous Process
1
2
3
C5
Cold Pain Threshold
Cervical - Left
Cervical - Right
Cold Pain (6-14)
Comments:
________________________________________________________________________________________
______________________________________________________________________
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CHRONIC WHIPLASH EXERCISE TRIAL PROTOCOL
APPENDIX 10 – MEASURING CERVICAL SPINE RANGE OF MOVEMENT: INCLINOMETER METHOD
CERVICAL RANGE OF MOVEMENT – INCLONOMETER METHOD
Modified Hole et al (1995) protocol
Description
Measurement of active cervical range of motion using an inclinometer.
Instruments required
Analogue or digital inclinometer
Participant’s starting position
Flexion and extension
For flexion and extension the participant sits in a chair, trunk erect, looking straight ahead. To minimise trunk and shoulder
movement the participant should be encouraged to press their thoracic and lumbar spine against the back rest and to lightly
grasp the seat with their hands.
Rotation
For rotation the participant lies supine on a plinth. To minimise trunk and shoulder movement the participant is asked to keep
their shoulders in close contact with the plinth.
Starting position of examiner
Standing beside the patient for flexion/extension, at the front of the patient for lateral flexion and behind the patient for rotation.
Procedure
Flexion and extension
The inclinometer is positioned on the centre of the skull aligned to read movement in the sagittal plane (i.e. mid-sagittal plane
(line of nose) with the centre of the inclinometer in line with the external auditory meatus). Participants are requested to keep
their shoulders and trunk still by pressing against the chair back and holding onto the seat base with their hands and to then
slowly flex or extend the neck.
Rotation
The inclinometer is positioned on the forehead with the axis in line with the nose. The participant is then asked to maintain
their shoulders pressed against the plinth and to then turn their head slowly to the side.
Common errors to avoid
Failure to fixate the inclinometer, allowing the participant to move their trunk.
Reliability
Hole and colleagues27 evaluated the inter-rater reliability of the protocol using two student chiropractors as raters and 84
healthy volunteers as targets. They reported excellent inter-rater reliability with ICC values in the range 0.76-0.86.
Typical values
Approximate values for asymptomatic participants are given below.
Direction
Rotation
Flexion
Extension
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20 year old
75deg
65deg
80deg
60 year old
60deg
50deg
60deg
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CHRONIC WHIPLASH EXERCISE TRIAL PROTOCOL
APPENDIX 11– MEASURING COLD PAIN THRESHOLD OVER THE CERVICAL SPINE
Description
Measurement of cold pain threshold over the cervical spine using the Thermotest system.
Instruments required
Thermotest system.
Plinth.
Participant’s starting position
The participant lies on a plinth in prone.
Starting position of examiner
Standing beside the participant/plinth.
Procedure
•
The thermode is applied, either to the left or right of the cervical spine.
•
The participant is asked to depress a switch the first instant that the sensation changes from one of cold to one of cold and
pain
•
The value at switch press is automatically recorded and transposed to the appropriate site on the ‘Examination Data
collection sheet’.
•
Three cold threshold measures are taken.
•
Altered thermal thresholds provide indication of sensory hypersensitivity (≥ 13ºC – outside confidence intervals found for
asymptomatic controls)
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CHRONIC WHIPLASH EXERCISE TRIAL PROTOCOL
APPENDIX 12 – MEASURING PRESSURE PAIN THRESHOLD OVER THE CERVICAL SPINE AND THE TIBIALIS ANTERIOR
Description
Measurement of pressure pain threshold over the cervical spine (C5 spinous process) and tibialis anterior using Pressure
Algometry at a rate of 40kilopascals/sec.
Instruments required
Pressure Algometer.
Plinth.
Participant’s starting position
Cervical spine – C5 spinous process
The participant lies prone on a plinth.
Tibialis anterior
The participant lies supine on a plinth.
Starting position of examiner
Standing beside the participant/plinth.
Procedure
•
The thermode is applied to the assessment area – C5 spinous process and muscle belly of tibialis anterior - left and
right.
•
The participant is asked to press an electronic switch when their pain threshold is reached, that is “the moment the
pressure sensation becomes one of pressure and pain”
•
The pressure at the time of the switch press is automatically recorded on the algometer and it is then transposed to the
appropriate site on the Examination Data collection sheet.
•
Three measures of PPT are taken at each of the three assessment sites.
•
Lower pain thresholds provide indication of mechanical hypersensitivity.
The values below represent those outside confidence intervals for asymptomatic controls
Tib Ant:
< 410 kPa (males); 304 kPa (females)
C5:
< 210 kPa (males); < 185 kPa (females)
APPENDIX 13 – UTILITY WEIGHTS: INSTRUCTION AND RECORDING SHEET
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CHRONIC WHIPLASH EXERCISE TRIAL PROTOCOL
INTRODUCTION TO STANDARD GAMBLE
“Thank you. Now I’d like to run through some hypothetical questions with you. These questions will help us
understand the choices that patients make. Your answers are confidential; so they won’t influence the treatment you
receive in the trial or elsewhere.”
STANDARD GAMBLE
“Now I am going to ask you consider two possible choices, about treatment and your neck symptoms, and ask you
which choice you would take. “
“One choice involves a treatment that cures your neck symptoms and you will be healthy for 30 years. However the
treatment also carries a risk of death. We use this device here, called a “probability wheel”, to illustrate the chances of
death and the chances of cure. The wheel is divided into two sectors: a blue or healthy sector and a red sector for
death. At the moment the wheel is three-quarters blue and one-quarter red. So if you select treatment there is a 75%
chance of a cure and a 25% chance of death. “
“The other choice you have is not to have the treatment; but the neck symptoms you have right now persist for the next
30 years. “
“I will use the probability wheel to show you different chances of cure or death with treatment and then ask you if you
would choose to have the treatment or not. Do you understand? “
Allow the patient to ask questions. If they do not ask any questions ask them to explain in their own words what the
task involves. Clarify any misunderstandings.
Start with the probability wheel showing 25% risk of death
“At the moment the probability wheel shows a 25% risk of death and a 75% chance of cure with treatment. Would you
choose to have the treatment or not?”
If the subject chooses not to have treatment, decrease the death probability 5% and ask the subject to choose again.
“OK the wheel now says the probability of death has dropped to 20% and the probability of cure is 80%. Now would
you have the treatment? “
If the subject chooses treatment, increase the death probability 5% and ask the subject to choose again.
“OK the probability wheel now shows a probability of death of 30% and of cure of 70% if you choose treatment. What
would your choice be?”
Repeat this exercise until the choice changes
If the subject chooses not to have treatment at 5% risk of death, then decrease the probability in increments of 1%
until the choice changes or you reach 0%.
We are testing for the respondent’s point of indifference between treatment with a risk of death and no treatment. This
will generally by an increment of 2.5 unless the value is between 0 and 5% in which case it should be an in increment
of 0.5
Record the “indifferent probability” (usually the two boundary probabilities) at the end of the exercise.
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CHRONIC WHIPLASH EXERCISE TRIAL PROTOCOL
Utility weights record sheet
Assessor to complete this section
Standard Gamble
Probability 1
Probability 2
Indifferent probability
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APPENDIX 14 – HOME EXERCISE DIARY
Participant’s Initials
Chronic Whiplash Exercise Trial
Participant Number
COST DIARY
Date – 14 week follow up
_____/_____/_____
One part of this trial involves an economic analysis to look at the costs people with whiplash incur as a result of their condition.
1.
In the last two weeks have you attended any appointments as a result of your whiplash symptoms, e.g. medical specialist, GP, Physiotherapist,
Psychologist, massage, acupuncture? YES please provide details below; NO
Appointment type
Est. total
travel
distance
(private
vehicle, km)
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Est of total
travel time
and waiting
time (min)
Duration of
visit (min)
Visit was
initiated by
(e.g. self, GP,
insurer,
specialist)
Total price
charged
Page 62 of 102
Out of pocket
price (i.e. how
much you
paid)
Parking costs
or public
transport
costs
Number of
visits
APPENDIX 14 – HOME EXERCISE DIARY
Participant’s Initials
Chronic Whiplash Exercise Trial
Participant Number
COST DIARY
Date – 14 week follow up
2. In the last 2 weeks have you PAID someone to assist you with daily activities as a direct result of your whiplash symptoms?
below;
_____/_____/_____
YES please provide details
NO
Home help (e.g. Nursing Care)
Domestic help (e.g. Cleaners)
Other (please specify)
Office Use Only
Type
Type
Type
Hours
Hours
Hours
Cost
Cost
Cost
Type
Type
Type
Hours
Hours
Hours
Cost
Cost
Cost
Type
Type
Type
Hours
Hours
Hours
Cost
Cost
Cost
Hours
Cost
3. In the last 2 weeks have you needed to call on unpaid assistance e.g. from friends or family to assist you with daily activities or attend appointments as a direct
result of your whiplash symptoms?
YES please provide details below;
NO
Family/friends in their own time (total hours):
_________________________________
Family/friends requiring them to take time off work (total hours)
_________________________________
Lancet_Web_appendix
Draft 7
Page 63 of 102
APPENDIX 14 – HOME EXERCISE DIARY
Participant’s Initials
Chronic Whiplash Exercise Trial
Participant Number
COST DIARY
Date – 14 week follow up
_____/_____/_____
4. In the last 2 weeks have you taken time off work due to your whiplash injury or have there been any activities you have been unable to do as a result of your injury,
if so please give details? YES please provide details below;
NO
Time away from work (egg sick leave) because of Whiplash Injury (total hours)
_________________________________
Time unable to perform usual activities because of injury (total hours)
_________________________________
5. In the last 2 weeks have purchased any medication to be taken specifically for your whiplash symptoms?
YES please provide details below;
Medication (Name and dose)
NO
Prescribed
Non-prescribed
No. of doses consumed/week
____________
Cost
____________
No. of doses consumed/week
____________
Cost
____________
No. of doses consumed/week
____________
Cost
____________
No. of doses consumed/week
____________
Cost
____________
No. of doses consumed/week
____________
Cost
____________
6. In the last two weeks have you been required to cover any other costs as a direct result of your whiplash symptoms e.g. pillow, ergonomic devices, please
provide details and an approximate cost. YES please provide details below; NO
___________________________________________________________________________________________________________________________________
_________________________________________________________________________________________________________
Lancet_Web_appendix
Draft 7
Page 64 of 102
APPENDIX 14 – HOME EXERCISE DIARY
Participant’s Initials
Chronic Whiplash Exercise Trial
Participant Number
COST DIARY
Exercise week
Date:
Aerobic
EXAMPLE
ONLY
20 min walk
Posture training
RPE: 9
H/W
Cue
email
pop up
Neck flexors
(CCF training)
Train
pattern,
5s hold
if applic
Neck extensors
Scapular
training
10s
Sensorimotor
30s
tandem
eyes
open
_
Range of
movement
Exercise week
Date:
Aerobic
R
S
Every
15
mins
10
2
5
2
10
2
_____/_____/_____
Date – 14 week follow up
Week 1
…./…./….
Week 2
…./…./….
Week 3
…./…./….
Week 4
…./…./….
H/W
R
S
H/W
R
S
H/W
R
S
H/W
R
S
H/W
R
S
5
5
3 sets
a day
Week 5
…./…./….
Week 6
…./…./….
Week 7
…./…./….
Week 8
…./…./….
Week 9
…./…./….
Week 10
…./…./….
H = hold; W = weight; R = repetitions; S = sets; = Tick for each day you complete each exercise (e.g. do exercises 4 times in a week = four ticks)
exercises 4 times in a week = four ticks)
Page 65 of 102
APPENDIX 14 – HOME EXERCISE DIARY
Participant’s Initials
Chronic Whiplash Exercise Trial
Participant Number
COST DIARY
H/W
R
S
H/W
_____/_____/_____
Date – 14 week follow up
R
S
H/W
R
S
H/W
R
S
H/W
R
S
H/W
Neck strength
and endurance
Upper limb
Lower limb
Sensorimotor
Functional
activity
H = hold; W = weight; R = repetitions; S = sets; = Tick for each day you complete each exercise (e.g. do exercises 4 times in a week = four ticks)
Page 66 of 102
R
S
APPENDIX 14 – HOME EXERCISE DIARY
Participant’s Initials
Chronic Whiplash Exercise Trial
Participant Number
COST DIARY
Exercise week
Date:
Aerobic
Week 11
…./…./….
H/W
R
S
Week 12
…./…./….
H/W
_____/_____/_____
Date – 14 week follow up
R
S
H/W
R
S
H/W
R
S
H/W
R
S
Neck strength
and endurance
Upper limb
Lower limb
Sensorimotor
Functional
activity
H = hold; W = weight; R = repetitions; S = sets; = Tick for each day you complete each exercise (e.g. do exercises 4 times in a week = four ticks)
Page 67 of 102
H/W
R
S
APPENDIX 14 – HOME EXERCISE DIARY
Chronic Whiplash Exercise Trial
COST DIARY
Participant’s Initials
Participant Number
Date – 14 week follow up
_____/_____/_____
Rate of Perceived Exertion (RPE) scale (Borg 1970)
RPE Scale
6
7
8
9
10
11
12
13
Effort %
20% effort
30% effort
40% effort
50% effort
55% effort
60% effort
65% effort
70% effort
14
75% effort
15
16
17
18
19
20
80% effort
85% effort
90% effort
95% effort
100% effort
Exhaustion
Descriptor
Target intensity
Very, very light (Rest)
Very light gentle walking
Fairly light
Somewhat hard steady
pace
Hard
Very hard
Very, very hard
Page 68 of 102
Moderate level of
intensity
Talk test: exercising
at an intensity that
allows for
comfortable speech
Web appendix 2: Therapist manual
A randomised controlled trial of a comprehensive exercise program for chronic whiplash
C Maher, M Sterling, G Jull, J Latimer, L Connelly
The University of Sydney; The University of Queensland
Physiotherapy Management Protocol
Introduction
The management program under investigation combines sequentially, motor relearning and graded exercise, for individuals
with a chronic whiplash associated disorder and aims to relieve the individual’s pain, improve their function and return
them to their pre-injury work or home activity status. It is conducted over a 12 week period with the participant attending
the physiotherapist twice per week for the first eight (8) weeks and once per week for the final four (4) weeks. An
important element of the program is that participants need to be involved in setting goals and also complete their activity
charts so that they can monitor their progress.
This protocol provides an outline of our requirements of you as a trial physiotherapist as well as a comprehensive guide to
assessment requirements and exercise prescription. The assessment required throughout the management period underpins
the exercise prescription and progression. The physiotherapist can tailor the management program to the individual
participant’s presentation and functional goals. Nevertheless, the physiotherapist must prescribe exercises as per the intent
of the research protocol, which focuses on motor relearning elements in the first 4 weeks and the graded activity program
in the next 8 weeks. In the first four weeks manual therapy (excluding cervical spine manipulation) can be provided as
required in a multimodal context, to assist achievement of the goals of the motor relearning program. There can be some
flexibility in the transition period (weeks 4 and 5). For example, one participant may be ready for progression to higher
load exercise a little earlier and another a little later. We are reliant on your skill as a physiotherapist to guide this transition
appropriately on the basis of your continuous reassessment. Aerobic exercise should be introduced from the outset of the
management program. An overall view of the program is presented below.
The delivery of the exercise program should follow the principles of: positive reinforcement by participant and
physiotherapist, goal setting and self monitoring of progress (through diaries), continuous reassessment, addressing
unhelpful beliefs and encouraging skill acquisition by modelling. Once the transition to graded activity has occurred, the
principles of pacing and exercise quotas should also be incorporated. An extract of a book chapter by Nicholas et al (2004)
has been included in Appendix 7 which provides detailed information on application of these principles in a CBT context.
It is written for low back pain, but the principles can be applied to the management of whiplash associated disorders.
Page 69 of 102
General Procedures
1.
The trial centre will contact your practice to arrange a suitable time for the participant’s first appointment. You will
be provided with a participant record proforma and a brief overview of the participant’s history and summary of
baseline measures taken at the trial centre.
2.
Participant record proforma (Appendix 8). Please use this proforma to record:
• Dates of attendance
• Initial assessment
• Outcome measures (PSFS; physical measures relevant to the exercise intervention)
• Initial management and exercise program
• Details of progressive assessment and management in the 20 sessions
• A record of participant compliance with the exercise program
• The total duration of each treatment session as well as a breakdown of each session into minutes of 1:1 contact
with participant and separately the time required to complete trial paperwork.
3.
Keep a copy of the home exercise program that is developed with the participant and its progressions at each
management session.
Please check participants are completing their diaries. We are using diary entries as a measure of compliance so this is
important for the study.
4.
What to do if there is an adverse event
Minor fluctuations in whiplash symptoms are not an adverse event and do not need to be reported. These could be
expected when the participant is embarking on an exercise program. If this occurs:
• Check performance and design of the exercise, modify if necessary
• Provide assurance
• Retain the emphasis on an active and graded approach
An adverse event (AE) is any untoward medical occurrence in a participant temporally associated with the trial
intervention, whether or not considered related to the trial intervention. Examples of an AE include:
• Exacerbation of a pre-existing condition
• New conditions detected or diagnosed after enrolment in the trial
Examples of an AE do not include anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s)
present or detected at the start of the study that do not worsen.
A serious adverse event (SAE) is one that is life threatening requires inpatient hospitalisation or will result in
persistent or significant disability or incapacity.
All adverse events need to be immediately reported to the Adverse Events Committee for the trial (Chris Maher,
Michele Sterling). In NSW, concerns should be addressed to Chris via phone on (02) 9657 0382. In Qld, contact
Michele on (07) 3365 5344. Please do not contact other trial personnel for ‘blinding’ reasons. In the unlikely event of a
SAE trial recruitment and treatment should be put on hold pending advice from the Adverse Events Committee. The
Adverse Events Committee will report all AE and SAE to the relevant ethics committee.
5.
Cancellation Policy. Each participant should receive 20 exercise sessions. A participant is able to cancel up to 2
sessions without penalty (i.e., these 2 sessions may be made up within the 12 week period). If a participant cancels or
fails to attend on more than 2 occasions, these sessions will not be made up. Each participant will receive a sheet
outlining the procedure to be followed for cancellations.
Please notify the trial centre if a participant has failed to attend on more than two occasions
NSW Contact:
QLD Contact:
Dr Christine Lin
Tel: 02 8238 2437
Email: clin@george.org.au
Ms Stephanie Valentin
Tel: 07 3636 4214
Email: s.valentin@uq.edu.au
Page 70 of 102
Management Protocol at a Glance
This section provides guidelines at a glance for the Specific Motor Relearning Exercise and the Graded Exercise
Components of the trial management program. Please refer to the following appendices for further details:
Appendix 1: Initial and progressive assessment to direct specific exercise prescription
Appendix 2: Guide to the Motor Relearning Program (Weeks 1-4)
Appendix 3: Technical notes for the motor relearning program
Appendix 4: Overview of Graded Exercise Program (Weeks 5-12)
Appendix 5: Examples of activity tests
Appendix 6: Borg Rating of Perceived Exertion (RPE) Scale
Week
Sessions per
week
Overview of Components
1
2
2
2
3
2
4
2
Baseline & follow-up assessments to guide initial prescription & progression of
program
Exercises to improve cervical and scapular muscle control, kinaesthesia & balance
Manual therapy if indicated (excluding cervical spine manipulation)
Education and advice
Progressive home exercise program; aerobic exercise program
Transition
5
2
6
2
7
2
8
2
9
2
10
1
11
1
12
1
Baseline & follow-up assessments to guide initial prescription & progression of
program
Supervised exercise program to improve the participant’s functional abilities progress aerobic, range of motion, expand strength, endurance, coordination and
functional exercises.
Daily home program including exercise & graded increase of physical activities
Graded activity program using CBT principles
Discharge session to reinforce progress and plan for continued activity
Reminder:
We require the following information to be recorded on participant record proforma at each session of attendance.
•
Date of attendance
•
Follow-up assessment findings, additional progressive assessments; participant’s achievements and compliance with
exercise
•
Follow-up of PSFS – complete every 2 weeks – Establish new functional goals once the participant has indicated a
score of 9 or 10 for any function
•
Details of management and exercise progression and breakdown of treatment duration
•
Record the home exercises in a diary for the participant and keep a copy of the exercise diary. Check that the
participant is completing the diary and ensure they know how to record their adherence to the program.
Page 71 of 102
Weeks 1-4: Specific Motor Relearning Exercise Component
Session 1: (week 1)
Complete the initial participant interview and physical assessment (Appendix 1) on the proforma provided and establish
participant-centred goals based on the PSFS.
The management session should contain the following elements:
1. Participant education regarding the nature of their whiplash injury and based on assessment findings, the nature of
associated muscle dysfunction and the rationale behind the specific motor relearning exercises. The physiotherapist
should ensure the participant has an understanding of their pain and help shape beliefs incorporating CBT principles.
2. Therapeutic exercise: Based on their analysis, the physiotherapist facilitates correct muscle activation for the cervical
region and shoulder girdle with specific training exercises as well as functional training in posture. The participant is
taught the specific motor relearning strategies (Appendix 2; 3).
3. Any relevant manual therapy (excluding cervical spine manipulation) can be performed, but should not detract from
the active approach to management.
4. Prescribe and teach home exercise program – ensure participant has correct strategies and understands how to
complete the exercise diaries.
5. Commence aerobic exercise program (see Appendix 4; 6).
6. Record the home exercise program for the participant, including exercise dosage.
7. Book the next follow up session.
Sessions 2-8
1. Perform a follow-up assessment of the participant and record findings on the participant record proforma, document
achievements. Formally complete the PSFS every 2 weeks and modify as participant progresses. Check exercise diary
and participant’s activity chart.
2. Continually progress the specific motor relearning tasks, movement re-education and functional training guided by
assessment outcomes (Appendix 2, 3).
3. Monitor and progress the aerobic exercise program as indicated (Appendix 4).
4. Clearly document exercise and management progressions.
5. Reinforce CBT principles as required.
6. Record the home exercise program for the participant, including exercise dosage.
7. The exercise program may have an earlier transition to the graded exercise program and this will be based on
participant achievement of goals in motor relearning.
8. Book the next follow-up session.
Weeks 5-12: The Graded Activity Program
Note: the emphasis in this phase of the management program, which begins in week 5, changes from specific motor
relearning exercises to more general whole body functional exercises.
The physiotherapist should aim for a seamless transition between the motor relearning phase and the graded exercise phase.
Depending on the particular participant, the graded exercise or components of it may begin earlier, that is, in week 4 and
for others it may begin a little later that is, in week 6. However this should be the outer limit to commence the graded
exercise program.
For example: the motor relearning program begins the elements of strengthening for the neck muscles and in a
seamless transition, these should be progressed into the principles adopted for the graded exercise program in week 5; the
full progression of the exercises for cervical somatosensory function (e.g. balance), may not have been fully achieved in
the 4 week period and the progressions can continue into the graded exercise program in a seamless way.
Session 9: (week 5)
1. Perform a follow-up assessment of the participant and record findings on the participant record proforma, document
participant achievements. Check exercise diary and participant’s activity chart.
2. Review current PSFS goals and identify the participant’s current ability to complete the specific functional goals.
3. Perform a tailored physical and functional assessment to focus on components which are essential for the participant to
be able to achieve their specific functional goals as identified in the PSFS.
4. Gain baseline measures of strength/endurance/functional capabilities (Appendix 4; 5).
Page 72 of 102
5.
Identify reasons for the participant’s inability to complete the specific functional activity, specifically in terms of
duration, intensity and factors limiting continuation of the activity (e.g. fatigue, pain) to develop the graded exercise
program.
6. Prescribe exercises on CBT principles using the formula:
- Reduce the duration or intensity to 80% of the participant’s current ability. This is the starting exercise intensity.
7. Review the goals listed and discuss with the participant an appropriate timeframe to achieve the goals with reference
to the nominated PSFS measures.
8. Prescribe and record 6-8 exercises for the participant to continue at the next session at the above exercise intensity.
9. Record a home exercise program, comprising of up to 4 exercises, in the exercise diary.
10. Book the next follow up exercise session.
Sessions 10-20
1. Perform a follow-up assessment of the participant and record findings on the participant record proforma, document
achievements. Formally complete the PSFS every 2 weeks and modify as participant progresses. Check exercise diary
and participant’s activity chart.
2. Continually progress the program components of aerobic capacity/strength/endurance /functional capabilities
(Appendix 4, 5).
3. Clearly document exercise and management progressions.
4. Reinforce CBT principles as required.
5. Record the home exercise program, including exercise dosage.
6. Book the next follow up session.
At the last session – discuss the follow-up assessment at the trial centre and ensure that the participant has a time
booked by the trial centre.
Ensure the participant has mapped a program of continuing activity and exercise
Page 73 of 102
Appendix 1:
Initial assessment to direct specific exercise prescription
Analysis of participant’s provocative postures, functions or movements
(i)
Directed by the participant interview, analyse the participant’s main postures, functions or movements that are
provocative of pain.
(ii) Analyse the reasons why these manoeuvres might be provocative in terms of postural attitudes, muscle or movement
dysfunctions.
(iii) Attempt to alter postures or positions so that the task/position is less painful. This serves as a powerful treatment and
educational directives.
Analysis of Posture: perform in sitting
Analysis of spinal posture
(i)
Analyse the participant’s habitual sitting posture (i.e. ideal is a neutral lumbo-pelvic (L/P), thoracic (T), cervical and
shoulder girdle position; observe for too much flexion or too much extension in the L/P and T regions).
(ii) Check range and pain response and range of cervical rotation in each direction in their habitual posture (baseline).
(iii) Analyse their attempt to assume an ideal sitting posture.
(iv) Observe any poor pattern e.g. predominant use of thoraco-lumbar erector spinae with an inability to assume a neutral
lumbo-pelvic position; over extension of thoracic region, alternately - too much flexion of thoracic region.
(v)
Facilitate the correct L/P postural position and thoracic region if necessary.
(vi) Assess effect of change in posture on: cervical range of movement and pain response (Treatment and education
directives).
(vii) Can the participant replicate an ideal sitting posture once taught and if not what is the reason - kinaesthetic ability,
poor active control, loss of passive mobility (Treatment directives).
Analysis of scapular posture
(i)
Observe and analyse any positional fault of the scapulae in habitual posture.
(ii) Repeat baseline cervical ROM test in each direction.
(iii) Facilitate correct sitting posture and then manually position the scapula in a neutral posture on thorax (do separately
and choose most deviated scapula first; analyse components of correction).
(iv) Check cervical rotation ROM and pain response (treatment and education directives).
Scapular muscle assessment (initial)
Analysis of scapulae under light load
(i)
Gently resist each of shoulder flexion, abduction and external rotation.
(ii) Reveals where specific weaknesses lie.
Analysis of scapular control during arm flexion and abduction
(i)
Assess control during concentric and eccentric phases as per an examination of the glenohumeral joint.
Scapular holding test in prone
(i)
Modified grade 3 test of the lower trapezius (arm rests by side to eliminate arm load).
(ii) Perform after manual examination of the cervical spine – obtain baseline VAS of most symptomatic segment.
(iii) Passively place scapula in a neutral position on the chest wall and require the participant to hold the position.
Outcome
a) Balanced use of scapular synergists or predominant use of one muscle group e.g. lat dorsi;
b) Observe for fatigue tremor or movement of scapula indicting a loss of holding capacity.
(iv) Re-assess manual examination and determine change in quality of joint feel and VAS score (Treatment and
education directives).
Cranio-cervical flexion test (CCFT)
Test of pattern of cranio-cervical flexion
Preparation
(i)
Test for neural tissue mechanosensitivity: supine lying, assess passive CCF range and resistance and retest in
sensitising positions of SLR and BPTT.
(NB, the presence of NT mechanosensitivity will modify how CCF is trained).
Also gauge ROM of CCF.
(ii) Prepare participant, supine, crook lying, ensure cranio-cervical and cervical regions are in a neutral position (support
with a folded towel if necessary).
(iii) Prepare PBU and insert behind neck and draw up to the sub-occipital region. Inflate to baseline of 20mmHg;
stabilise air and re-inflate to achieve 30mmHg.
(iv) Teach the CCF action. Use instructions of ‘feel the back of your head slide up the bed as you nod your chin’.
(v)
Explain dial of PBU and requirements of the task.
Page 74 of 102
Stage 1 CCFT
(i)
Request participant to nod to target sequentially 22, 24, 26, 28, 30 mmHg. They hold each position for a couple of
seconds before relaxing. Use the instruction to slide back of head up the bed and nod to target pressure.
Ensure that the participant performs the movement slowly.
(ii) Analyse: pattern of movement
- Does participant perform sagittal rotation (correct) or a rotation/retraction action/retraction action (incorrect) Note
retraction is seen when there is a direct descent of the head, or when they are using almost the same range of CCF to
attain each target pressure.
- Is there unwarranted activity in the sternocleidomastoid (SCM), anterior scalene (AS) muscles.
- Is there over-activity of hyoids? – retest with mandible in relaxed position
- Is there breath holding? ensure the participant nods with exhalation
Outcome: pressure level participant can achieve with correct movement and nil to little use of SCM/AS
Stage 2 CCF low level endurance or holding capacity
Stage 2 of the test is only performed when the participant has a correct CCF pattern. Often this stage of the test has to be
performed on the second treatment as first aim in rehabilitation is to train the participant to achieve the correct movement
pattern.
(i)
Set up participant and PBU as above.
(ii) Test holding capacity at each progressive pressure level.
(iii) Ensure correct pattern is used at all times.
(iv) In testing the participant is required to hold for about 5 secs and a decision should be able to be made for a particular
pressure target after 3 or 4 attempts.
(v)
An inability to perform a tonic hold at the respective level is evident when:
- The pressure cannot be maintained on the target.
- The participant reverts to a retraction pattern to hold the pressure.
- There is phasic activity of the superficial flexors (pressure is not held steadily).
Outcome: determine the level the participant can hold and that will be the starting point in
training.
Assessment of craniocervical and cervical extensors
The test exercise is performed either prone on elbows or in four point kneeling. This is not a test with absolute outcomes,
but more a pre-exercise assessment/instruction, that will lead into an exercise protocol. In the test position, all extensor
muscles will work to hold the head against gravity. However we know from research that the suboccipital muscles and the
deep cervical muscles (multifidus and semispinalis cervicus) atrophy or may have fatty infiltrate. Therefore the movement
strategies are designed to be biased towards those muscles.
(i)
Sub-occipital muscles: Focus on a neutral neck position
- require the participant to perform cranio-cervical extension (chin down).
- require the participant to perform cranio-cervical rotation (the saying ‘no’ action).
Assess quality of movement and for smooth co-ordination.
(ii) Deep cervical extensors: the cranio-cervical region remains in neutral and the axis of motion is now at C7.
- instruct the participant to curl their neck first into flexion and then to curl their neck back to extension. The
participant will often require manual facilitation to achieve the correct action.
To assist in maintaining the cranio-cervical neutral position, let the participant imagine they have a book between
their hands and they must keep their eyes on the book as they lift their head. Check that muscles such as splenius
capitis are not overactive.
Outcome: many participants cannot extend much beyond neutral to begin with (not a pain
protection
response). Others will fatigue quite quickly.
Progressive assessment
Scapular function
(i)
Assess control of serratus anterior in prone on elbows or 4 point kneeling.
(ii) Assess scapular control in functional tasks pertinent to the participant’s work activities.
Observe or palpate pattern of use, their maybe underactivity of the trapezius on the dominant side, or there can be
overactivity. Observe control of scapular position during the task. Can take task to fatigue.
(iii) Test fatigability of the upper trapezius – repeated bilateral arm abduction to overhead height.
Outcome: fatigue is often readily displayed.
Pattern of cervical flexor eccentric-concentric control (should be holding at least 26-28mmHg in CCF training).
(i)
Examine pattern in available range of cervical extension in sitting.
(ii) Examine holding ability in progressively increasing ranges of cervical extension (obtain baseline for progression of
endurance exercises).
Page 75 of 102
Cervical somatosensory function
The three elements tested are:
• Cervical reposition sense, cervical movement sense
• Eye movement control
• Balance
Cervical reposition sense
Use prepared target and a laser light.
Position participant in sitting, one meter from target. Attach target to wall once the participant is in the relaxed sitting and
‘neutral’ position.
Test with eyes closed or use eye mask.
(i)
Test relocation from each of rotation (L), (R) and extension.
(ii) The participant should repeat the movement 3-5 times. Between repetition, participant keeps their eyes closed, the
therapist repositions the head to neutral between each repetition.
Outcome: mark the average reposition error on target >4.5 mm is abnormal.
Cervical movement sense
Use prepared target and a laser light. Position participant in sitting, one meter from target.
(i)
Require participant to trace the laser light within the boundaries of the target. Require to go from left to right and
from right to left.
Outcome: abnormal if 4-5mm outside central line. Also assess whether the participant can
perform
with a reasonable speed.
Eye movement control
Gaze Stability- (Eyes still - head moves)
(i)
Fixate Gaze - Rotation of head
- Vertical movement of head
Outcome: - Difficulty maintaining focus
- Symptoms reproduction
- Marked decrease in ROM
Smooth pursuit neck torsion test (Head still eyes move)
Sit participant on a swivel chair.
(i)
Participant focuses on target (e.g. a pen) and therapist moves the target through visual angle of 40 degrees crossing
the midline left to right at a speed of 20 degrees per second.
(ii) Perform at least 5 times to make a judgement. Observe for saccades, especially observed around the mid line (not
like nystagmus which is observed at the periphery). Make baseline judgment.
(iii) Keep participant’s head still and rotate trunk to the left approximately 45 degrees. Repeat test of eye follow.
(iv) Keep participant’s head still and rotate trunk to the right approximately 45 degrees. Repeat test of eye follow.
Outcome: There is a difference in saccadic movement between the trunk neutral and trunk
torsioned
positions.
Eye head co-ordination
(iv) Eyes move first to 30 degrees and then head to 30 degrees keeping focused- return to neutral.
(v)
Perform to both sides, repeat 3 or 4 times.
Outcome: - Difficulty controlling co-ordination.
- Ability to move head and eyes independently.
- Symptom reproduction.
Saccadic Movements
Head is kept still
(vi) Participant’s fix gaze on and follow a target (e.g. a pen) that the therapist moves quickly and then holds still.
(vii) The target is moved in several different directions – pure planes, diagonals.
Outcome: - Difficulty controlling the task.
- Inability to move eyes independently of head.
- Symptoms reproduction.
Balance
Test balance to determine the level the participant is capable of performing
(i)
Foot position: Comfortable
Page 76 of 102
Narrow
Tandem
Single leg
(ii) Eyes open vs closed (shown that conditions with eyes closed have more discrimination for WAD)
(iii) Surface- firm; progressing to soft, progressing to unstable
Outcome: Ability to maintain the stance position for 30 secs
Check for increased sway, rigidity, dizziness
Reference text
Jull G, Sterling M, Falla D, Treleaven J, O’Leary S. Whiplash, Headache and Neck Pain: research based directions for
physical therapies. Churchill Livingstone, Edinburgh, Elsevier UK, 2008.
This text can be used to obtain more details of the assessment procedures and the management strategies described in the
following two appendices.
Page 77 of 102
Appendix 2:
Guide to the Motor Relearning Program (Weeks 1-4)
Introductory notes
The following is a guide only and provides the components of the exercise program for the first 4 weeks of management.
The program must be individualised to the particular participant you are treating.
There should be a transition between the motor relearning and graded activity program. If the participant has not achieved
all the stages of motor relearning, then these can be continued into the following 6 weeks until targets are reached.
•
•
•
•
•
•
•
•
•
The assessment will provide baselines at which the participant can commence the various exercise protocols.
The rate at which exercises can be introduced will depend on the participant’s pain and disability level.
A fundamental rule is that the exercises must not produce pain, especially in those participants with evidence of
augmented central pain processing.
It is likely that it will take 2-3 treatments to introduce all basic components of the exercise program. However the rate
is variable and will be in response to the participant’s state. Do not become overzealous and exacerbate the
participant’s condition.
Teach, recheck and progress exercise program before performing any manual therapy in a treatment session. This will
ensure that the exercises are a predominant feature of the rehabilitation. The exercises also relax the deep neck muscles
such as the segmental multifidus which allows more effective performance of manual therapy techniques.
Joint mobilising exercises are also included in the program.
The home exercise program will replicate that performed in the treatment session. The participants should be
provided with some equipment to practise with at home (e.g. laser light, PBU at later stages).
Participants are required to practise exercises formally twice per day (once in the morning and once in the evening).
There is a particular emphasis on correcting to the upright neutral posture repeated during the day (every 15-20 mins)
as this is facilitatory of deep muscles, serves the need for multiple repetitions in the motor relearning process and has
the mechanical benefit of taking cervical joints away from their end of range.
The following tables provide a guide to the introduction and progression of the exercises over the 4 weeks, but progression
will always be individual to the participant, their starting point and their progress.
Successful motor relearning is reliant on the physiotherapist’s skill in movement and motor analysis and in
teaching. Participant compliance is also required. If participants are non compliant, reflect on find the reason why
and correct.
- Deficits in the physiotherapist’s communication skills?
- Importance of exercises not understood by participant.
- Program not tailored to participant’s other daily demands.
- Exercise program not clearly written out for participant.
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Guide to the motor relearning program
Week 1
Session 1
Session 2
Posture re-education
Posture re-education
- facilitate the upright lumbo-pelvic posture and correct
- Re-check ability to assume an upright neutral posture,
any thoracic deviation if required (leave head/neck at
may need to re-teach
- Re-check/teach scapular postural correction
this stage)
- teach participant a self correction strategy
- if the participant is able to correct spinal posture with
ease, teach scapular postural correction
Cranio-cervical flexion training
Cranio-cervical flexion training
- facilitate and teach the correct pattern of CCF
- Re-check the correct pattern of CCF movement
movement
- Perform formal tests of holding capacity, begin formal
retraining of low level endurance of CCF, starting at
- if nerve tissue mechanosensitivity is present, practice
from extension to neutral in supine lying, use gentle self
level participant can achieve (e.g. 22mmHg)
resistance
Cervical extensors
- teach and train the CCE and CE actions
Scapular muscle training
- train in side lying, facilitate as required
- emphasise correct pattern and train to hold the
contraction for 10 secs
- teach participant a home program strategy in side lying
with pillow support, 10x10 sec holds
Home Program
- posture training – emphasise every 15-20 mins,
discuss ‘cue to practise’ with participant
- CCF training – practice pattern with facilitation
strategies. Encourage to perform 3 sets of 10 movements
- Cervical extensors – perform one to two sets of 5 reps
for each of the three tasks
- Scapular training – side lying, 3 sets of 10 sec holds of
lower trap.
Cervical extensors
- teach and train the CCE and CE actions, progress
repetition to 2 or 3 sets of 5 reps of each exercise
Scapular muscle training
- recheck and train in side lying and check home
program strategy
- add in exercise for serratus anterior (preferably in
prone on elbows or 4 point kneeling to gain effect on
neck extensors)
Somatosensory function
- Commence retraining as indicated from the
examination.
- Kinaesthetic sense – relocation practice
- Balance
- Eye movement control – start with one exercise as
relevant to the participant
Mobilising exercises
- Depending on the participant, perform segmental or
ROM exercises
- Exercises for C/Th region often required
Home Program
- posture training – including scapular posture
- CCF training – ensure correct pattern. Practise 3 sets
of 10 x 10 sec holds
- Cervical extensors – perform two sets of 5 reps for
each of the three tasks
- Scapular training – side lying, 3 sets of 10 sec holds of
lower trap.
- Kinaesthetic, balance, eye movement as developed
from treatment program
- Active mobilising exercises as developed in treatment
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Session 3
Posture re-education
- Add the ‘occipital lift’ to postural exercise to
ensure good facilitation of the CCF
Cranio-cervical flexion training
- Progress training of the holding capacity. Target is
10x10 sec holds at 30mmHg
- Progress only as participant can maintain a good
patterns without excess activity of the superficial
flexors
Cervical extensors
- Train the CCE and CE actions, progress repetition
to 3 sets of 5 reps of each exercise
Scapular muscle training
- Continue to train in side lying, 10x10 sec holds
each side in home program
- Assess and train control in posture and with arm
movements to 30 degrees
- Progress serratus anterior exercise to 3 sets of 5
reps of ‘thoracic push ups’
Somatosensory function
- Kinaesthetic sense – relocation practice; add in
movement sense task
- Progress balance exercises
- Progress exercises for eye movement control –
train at least two tasks
Mobilising exercises
- Progress cervical segmental exercises
- Exercises for C/Th region
Home Program
- posture training – continues as a lifetime event
- Posture training with arm load
- CCF training – ensure correct pattern Practice 3
sets of 10 x 10 sec holds at variable pressure levels
- Cervical extensors – perform three sets of 5 reps
for each of the three tasks
- Scapular training – continue side lying exercise.
Add SA exercise
- Progress kinaesthetic, balance, eye movement as
developed from treatment program
- Active mobilising exercises as developed in
treatment
Week 2
Session 4
Posture re-education
- Begin gentle loading of the postural position, via
arm movement <30 degrees
Cranio-cervical flexion training
- Progress training of the holding capacity. Target is
10x10 sec holds at 30mmHg
Cervical extensors
- Train the CCE and CE actions, progress repetition
3 sets of 5 reps of each exercise
Scapular muscle training
- Continue to train in side lying
- Serratus anterior - 3 sets of 5 reps
- Train control in posture and with arm movements
to 30 degrees
- Re-educate scapular control through range of GH
abduction and flexion
Somatosensory function
- Kinaesthetic sense – relocation practice, increase
the complexity of movement sense tasks
- Progress balance exercises
- Eye movement control – perform the three tasks,
increase speed, change body position
Mobilising exercises
- Progress cervical segmental exercises; possibly add
MWMs
- Exercises for C/Th region
Home Program
- posture training – and include arm load exercises
- CCF training –Practise 3 sets of 10 x 10 sec holds
at variable levels.
- Cervical extensors – perform 3 sets of 8 reps for
each of the three tasks
- Scapular training – side lying, 3 sets of 10 sec
holds of lower trap. Continue SA exercise
- Progress kinaesthetic, balance, eye movement as
developed from treatment program
- Active mobilising exercises as developed in
treatment
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Week 3
Session 5
Session 6
Posture re-education
Posture re-education
- Add the ‘occipital lift’ to postural exercise to ensure
- Check correction of spinal and scapular posture
good facilitation of the CCF
- Progress gentle loading of the postural position, via arm
- Begin gentle loading of the postural position, via arm
movement <30 degrees with resistance 0.5 Kg
movement <30 degrees with resistance e.g. 0.5Kg
Cranio-cervical flexion training
Cranio-cervical flexion training
- Progress training of the holding capacity. Target is 10x10 - Progress training of the holding capacity. Target is
sec holds at 30mmHg
10x10 sec holds at 30mmHg
- Progress but maintain a good pattern
- Try to increase range of control of cervical extension
- Once participant can perform at 26mmHg, practice
controlled eccentric and concentric work through available
range of extension
Cervical extensors
Cervical extensors
- Train the CCE and CE actions, progress repetition to 3
- Train the CCE and CE actions, progress repetition 3 sets
sets of 8 reps of each exercise, ensure that participant is
of 8 reps of each exercise, ensure that participant is
gaining full cervical extension range
gaining full extension range
Scapular muscle training
Scapular muscle training
- Train control in posture and with arm movements to 30
- Progress serratus anterior to 3 sets of 8 reps
degrees with load (0.5Kg)
- Re-educate scapular control through range of GH
abduction and flexion
- Progress serratus anterior exercise to 3 sets of 8 reps of
‘thoracic push ups’
- Address fatigability of upper trapezius – start with 3 sets
- Continue to re-educate scapular control through range of
of 5 reps of full Abd ROM –with control
GH abduction and flexion
- Task specific training e.g. typing with balanced scapular
- Begin task specific training e.g. typing with balanced
muscle control
scapular muscle control
Somatosensory function
Somatosensory function
- Kinaesthetic sense – relocation practice, increase
- Kinaesthetic sense – relocation practice, ↑ complexity of
complexity of movement sense tasks
movement sense tasks
- Progress balance exercises
- Progress balance exercises
- Eye movement control – perform the three tasks,
- Eye movement control – perform the three tasks,
increase speed, change body position
increase speed, change body position
- Integrate eye movement and balance exercise
Mobilising exercises
Mobilising exercises
- Progress cervical segmental exercises; possibly add
- Progress cervical segmental exercises; possibly add
MWMs
MWMs
- Exercises for C/Th region
- Exercises for C/Th region
Home Program
Home Program
- posture training – and include arm load exercises with
- posture training – and include arm load exercises with
0.5Kg resistance
0.5Kg resistance
- CCF training – 3 sets of 10 x 10 sec holds at variable
- CCF training –Practice 3 sets of 10 x 10 sec holds at
variable levels. Practice eccentric control
levels. Practice eccentric control, full ROM abd, 3 sets of
- Cervical extensors – perform 3 sets of 8 reps for each of
5 reps
the three tasks
- Cervical extensors – perform 3 sets of 8 reps for each of
- Scapular training – side lying, 3 sets of 10 sec holds of
the three tasks
- Scapular training – side lying, 3 sets of 10 sec holds of
lower trap. Continue SA exercise
- Progress kinaesthetic, balance, eye movement as
lower trap. Continue SA exercise
developed from treatment program
- Progress kinaesthetic, balance, eye movement as
developed from treatment program
- Active mobilising exercises
- Active mobilising exercises
Week 4
Session 7
Session 8
Posture re-education
Posture re-education
- Check correction of posture, all components
- Check correction of spinal and scapular posture
- Increase loading of the postural position, via arm
- Progress loading of the postural position, via arm
movement <30 degrees with resistance e.g. 1Kg
movement <30 degrees with resistance 1kg
Cranio-cervical flexion training
Cranio-cervical flexion training
- Holding capacity. Target is 10x10 sec holds at 30mmHg
- Holding capacity. Target is 10x10 sec holds at 30mmHg
- Once participant can perform at 28-30 mmHg, practice
- Once participant can perform at 28-30 mmHg, practice
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controlled eccentric holds through different ranges of
extension
Cervical extensors
- Train the CCE and CE actions, progress repetition to 3
sets of 10 reps of each exercise, ensure that participant is
gaining full cervical extension range
Scapular muscle training
- Assess and train control in posture and with arm
movements to 30 degrees with load
- Progress serratus anterior exercise to 3 sets of 10 reps of
‘thoracic push ups’
- Fatigability of upper trapezius –3 sets of 10 reps of full
Abd ROM –with control
- Progress task specific training
Somatosensory function
- Kinaesthetic sense – relocation practice, increase the
complexity of movement sense tasks
- Progress balance exercises
- Eye movement control – challenge change body position,
do with walking
Mobilising exercises
- Cervical segmental exercises; add MWMs
- Exercises for C/Th region
Home Program
- posture training – and include arm load exercises with
1Kg resistance
- CCF training –Practise 3 sets of 10 x 10 sec holds at
variable levels. Practice eccentric holding in extension
- Cervical extensors – perform 3 sets of 10 reps for each of
the three tasks
- Scapular training – side lying, 3 sets of 10 sec holds of
lower trap. Continue SA exercise
- Bilateral shoulder abduction, 3 sets of 10 rep
- Progress kinaesthetic, balance, eye movement as
developed from treatment program
- Active mobilising exercises
controlled eccentric holds through different ranges of
extension
Cervical extensors
- Train the CCE and CE actions, progress repetition 3 sets
of 10 reps of each exercise, ensure that participant is
gaining full extension range
Scapular muscle training
- Continue to train in side lying
- Progress serratus anterior to 3 sets of 10 reps
- Re-educate scapular control through range of GH
abduction and flexion
- Address fatigability of upper trapezius – start with 3 sets
of 10 reps of Abd –with 0.5Kg
- Progress task specific training
Somatosensory function
- Kinaesthetic sense – relocation practice, ↑ the
complexity of movement sense tasks
- Progress balance exercises
- Eye movement control – challenge change body
position, do with walking
Mobilising exercises
- Cervical segmental exercises; add MWMs
- Exercises for C/Th region
Home Program
- posture training – and include arm load exercises with
0.5Kg resistance
- CCF training –Practise 3 sets of 10 x 10 sec holds at
variable levels. Practise eccentric holding in increasing
extension
- Cervical extensors – perform 3 sets of 10 reps for each
of the three tasks
- Scapular training – side lying, 3 sets of 10 sec holds of
lower trap. Continue SA exercise
- Bilateral shoulder abduction, 3 sets of 10 rep with 1 Kg
resistance
- Progress kinaesthetic, balance, eye movement as
developed from treatment program
- Active mobilising exercises
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Appendix 3
Technical notes
Facilitation of posture
There must be special and specific attention placed on retaining the upright postural position. The upright postural position
takes the joints of the neck off end range positions but importantly, when facilitated at the lumbopelvic region, it has been
shown to facilitate multifidus and longus colli/capitis.
The repeated correction of posture during the day is important in retraining the deep cervical flexors in their functional
role.
Pointers
- Some participants have extremely poor kinaesthetic awareness and struggle initially to learn the neutral lumbo-pelvic
position. If this is so, delay any teaching of scapular posture to the next session to give them the opportunity to master
the first phase. Trying too much too soon will lead to loss of one position.
- Ensure that you teach simple self facilitation strategies. For example:
Use their own thumb as a proprioceptive cue to regain a neutral L/P position;
Try simple strategies to improve scapular position – the 5% stretch of the diagonal rubber band on their chest for a
downwardly rotated, anteriorly tilted and protracted scapular, the 5% stretch of a rubber band placed horizontally
across their upper chest for protracted scapulae.
- Add in correction of head position as a third stage of posture correct. Teach as a gentle manoeuvre to lengthen the
back of the neck. This has been shown to strongly facilitate the longus colli.
Facilitation and re-education of the craniocervical flexion action
- Teach the action of head slide, this is the easiest form of feedback for the participant to learn the correct action.
- Utilise eye movement in facilitation.
- Use a spot on the ceiling to ensure participants can return to a neutral posture.
- Encourage relaxed breathing during the action.
- Instruct in the neutral mandibular position if there is a tendency to jaw clench or to substitute with the hyoids.
- Teach participant to self palpate superficial muscles. They must understand what a contracted and relaxed muscle feels
like.
- Even when training the CCF movement, emphasise the hold in CCF.
- Be very watchful of this exercise and do not underestimate the skill and attention required to have the participant
training their deep neck flexors effectively.
Training CCF holding capacity
The PBU is required in training the low level endurance of the CCF as neither the physio nor the participant can assess
holding accuracy without the feedback.
The potential error with using the PBU is that the participant (and physio) can fixate on the pressure dial and not on the
CCF action to achieve and hold the pressure. They can revert back to an incorrect pattern as their concentration is now
distracted to the dial. This results in totally ineffectual training as has been repeatedly observed in our whiplash research
unit. This can be avoided with the following strategies.
- In the first week (or a little longer if required), it is advised that the participant practise the holding action with
feedback from the PBU in the rooms only under the physios observation and they concentrate on performing the action
and feeling the correct sensation of the holding contraction with superficial muscles relaxed. They practise the 10
repetitions of holding concentrating on the CCF action and feel of the holding contraction in the home program.
- Once the participant has mastered the correct pattern they practise with the biofeedback and progress up the stages of
the action until they can hold 30mmHg for 10secs and do this 10 times. They must be repeated checked by the
physiotherapist to determine the maintenance of the correct action and the rate of progression.
- Some participants find it difficult to concentrate on the CCF action and the dial simultaneously. In these cases, the
physio/participant turns the dial away from the participant and the participant performs CCF to the desired level and
then they view the dial to give them feedback on the maintenance of the holding contraction.
- This strategy can eventually be used with all participants to train relocation accuracy and is a kinaesthetic training
strategy.
CCF training in the presence of nerve tissue mechanosensitivity
- If participants report increased pain with CCF training, the most likely reason is nerve tissue mechanosensitivity.
Always assess before commencing exercises.
- In these cases, train in supine initially from extension to neutral. The participant can use eye movement facilitation and
also use their thumb to provide gentle resistance and an isometric hold. As tolerated, increase the times and repetitions
of the holds in the neutral position, so that they too are doing 10x10sec holds.
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-
If possible, progress into some CCF range, if not possible in the 4 week time frame, stay with the isometrics.
Determine if there are other ways you can treat the nerve tissue sensitivity, e.g. sliding exercises.
Training the cervical extensors
- The CCE and C1-2 rotation are familiar movements and usually present no challenge to train. Ensure a good trunk and
scapular position.
- The CE is an unfamiliar movement and may require manual guidance when first training. The strategy of ‘keep
reading a book’ while curling the neck into extension usually keeps their CC region in neutral.
- Beware that participants will substitute an unwanted retraction action.
- Keep watching the superficial extensors, these should not predominate with the cervical extension exercise.
- Ensure that the physio can perform the correct action in standing, as demonstration is an effective teaching tool.
Training the interaction of the deep and superficial flexors
(i) This first part of training is re-teaching the action of cervical extension and return from extension in the sitting position.
To ensure appropriate balanced work between the muscle groups, the action focuses on initiating neck extension with
the chin, ensuring the head is gradually taken posterior to the shoulders and the return is led by cranio-cervical flexion.
This training commences once the participant can achieve at least 10x10 sec holds at 26 mmHg. Only move to
extension ranges that are pain-free.
(ii) The training is progressed to holding the extension position with an emphasis on control of the CCF position. These
exercises are performed in predetermined positions of extension as tolerated by the participant and the head is just
lifted off a wall or the therapist’s/participant’s hand.
(iii) The training is further progressed to head lifts from a resting position on two pillows with all concentration on
maintaining the CCF position and not allowing it to move into extension, which signals that the superficial flexors
have taken over all work.
Task specific training
Training scapular muscle control is a very important component oft the motor relearning program. Poor scapular control
can overload cervical joints as well as cause local discomfort in the axio-scapular muscles.
The low level endurance of the scapular stabilizers is often poor, and they need to be trained out of function (side lying), in
function (re-education of postural position), under light load (arm movements without and with light weights) and
importantly scapular posture and control must be trained in the tasks in which the participant reports pain. This is often
sitting and computer work, though it can be any function. It is necessary to train the participant in their nominated adverse
work condition so that they can perform it painlessly.
Training somatosensory function
- Base selection of exercises on findings of physical examination and relate exercises to level of dysfunction.
- If JPE, balance, oculomotor function are all impaired there is a need to address each individual impairment.
- Exercise 2-3 times per day, there is a need to take exercises to a point where they might provoke dizziness but they
should never exacerbate neck pain or headache.
- In progression consider combinations of eye and balance exercises.
Kinaesthetic sense
- repositioning to neutral with laser feedback (add to home program).
- repositioning to points in range with laser feedback.
- Movement position sense: follow patterns with laser, progress complexity of patterns.
- DNF retraining eyes open-closed.
Eye movement control:
Gaze stability
- Perform with neck rotation, flexion and extension.
- Progressions:- Body position, Supine, sitting, standing, walking
- Speed
- Focus point; pen, spot, complex background
- Imaginary - perform with eyes closed - open to check accuracy
Eye follow
- Directions: rotation, flexion/extension/diagonals; Neck torsion
- Progress Positions
- lying, sitting, standing (increase difficulty of stance position)
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- Progress speed
Saccades
- Directions: rotation, flexion/extension/diagonals
Balance
Progressions:
- Hard surface to foam to unstable
- Vision to no vision
- Wide to narrow base of support
- Two legs to one leg
- Functional- stairs, stepping
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Appendix 4
Graded Exercise Component
Overview
The graded activity program incorporates four (4) categories of exercise, with each category addressing the different
components or elements required to compete everyday tasks.
1.
2.
3.
4.
Aerobic exercise (began at the commencement of the exercise program however is being continued and progressed)
Range of motion exercise
Muscle strength and endurance exercises; Higher level sensorimotor exercises
Functional exercise
There are a number of different exercises in each category that the therapist can prescribe and progress on an individual
basis depending on the participant’s functional goals (identified from PSFS which is progressively monitored throughout
the program.
Each participant will be prescribed an exercise program to be conducted under the supervision of the physiotherapist which
will include 6 – 8 exercises, with at least one exercise from each exercise category. Participants will also be prescribed a
home exercise program, which will consist of up to 6 exercises (one exercise from each category). These exercises should
be modified to suit the participant’s individual functional goals.
Use baseline tests to establish where to start the participant in the series. In each case the participant should record their
accomplishments. The physiotherapist will select the exercises to perform and implement them considering the CBT
principles. Where prescription of exercise considering physiological principles conflicts with a CBT principles please
follow the CBT approach. For example if you decide to prescribe a walking program and the participants baseline walking
tolerance is 1 kilometre then you would start them training at 80% of 1 kilometre rather than follow the American College
of Sports Medicine’s (ACSM) guidelines and get them to walk for 20-30 minutes three times per week at 60-90% of max
heart-rate.
It is not essential that participant’s achieve a level of function which is in accordance with the ACSM guidelines. However,
these guidelines can be used in participants who have a higher level of baseline function. It is more important that the focus
is on participant’s achieving their functional goals and being increasingly self reliant, able to apply the CBT skills to set
and progress their own exercise goals.
The following sections describe the baseline assessments and suggest a progressive program for each element.
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1. Aerobic
•
Walking - progression – increasing speed, time, incline, carrying objects
•
Cycling (if participant has access to an exercise bike)
All participants need to perform aerobic training and the mode of aerobic training selected (e.g. walking, bike) must be able
to be continued in the home program.
This aerobic training should be commenced in week 1 of the program.
Establish the baseline performance with the participant, in accordance with the Borg RPE scale and assist the participant
develop the progressive aerobic exercise plan.
Borg Rating of Perceived Exertion (RPE) Scale
RPE Scale
6
7
8
9
10
11
12
13
14
Effort %
20% effort
30% effort
40% effort
50% effort
55% effort
60% effort
65% effort
70% effort
75% effort
15
16
17
18
19
20
80% effort
85% effort
90% effort
95% effort
100% effort
Exhaustion
Descriptor
Target intensity
Very, very light (Rest)
Very light gentle walking
Fairly light
Moderate level of
intensity
Somewhat hard steady pace
Talk test: exercising at
an intensity that allows
for comfortable speech
Hard
Very hard
Very, very hard
FOR REFERENCE:
American College of Sports Medicine (ACSM) guided targets:
AEROBIC:
Type
Duration
Intensity
Speed
Frequency
Walking, cycling
(any activity which employs large muscle groups in
activities that are rhythmic or dynamic in nature)
20 to 60 minutes of continuous or intermittent
activity
NB: aerobic exercise can be broken down into
intervals, minimum of 10 minute bouts
accumulated throughout the day
11 and 15 on the RPE scale
Participant dependant
4 -5 times per week
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Guide to Exercise Progression
WEEK 1-2
AEROBIC:
Type
Walking, bike
Duration
75% 80% of time achieved at initial assessment.
NB: aerobic exercise can be broken down into intervals,
e.g. 20 minutes achieved in assessment training early
minimum of 10 min bouts accumulated throughout the day
stage = 15-17 mins.
Intensity
11 and 13 on the RPE scale
Speed
Comfortable walk/cycle
Frequency
4 -5 times per week
WEEK 3-4
AEROBIC:
Type
Walking, bike
Duration
90% of time achieved at initial assessment
NB: aerobic exercise can be broken down into intervals,
minimum of 10 min bouts accumulated throughout the day
Intensity
11 and 13 on the RPE scale
Speed
Comfortable walk/cycle
Frequency
4 -5 times per week
WEEK 5-6
AEROBIC:
Type
Walking, bike
Duration
110% of time achieved at initial assessment aiming for
NB: aerobic exercise can be broken down into intervals,
30mins (20-60 mins) continuous exercise
minimum of 10 min bouts accumulated throughout the day
Intensity
11 and 13 on the RPE scale
Speed
Comfortable walk/cycle
Frequency
4 -5 times per week
WEEK 7-8
AEROBIC:
Type
Walking, bike
Duration
120 – 140%% of time achieved at initial assessment
NB: aerobic exercise can be broken down into intervals,
aiming for 30mins (20-60 mins) continuous exercise
minimum of 10 min bouts accumulated throughout the day
Intensity
11 and 13 on the RPE scale
Speed
Comfortable walk/cycle
Frequency
4 -5 times per week
WEEK 9-10
AEROBIC:
Type
Walking, bike
Duration
160% - 180% of time achieved at initial assessment
NB: aerobic exercise can be broken down into intervals,
aiming for 30mins (20-60 mins) continuous exercise
minimum of 10 min bouts accumulated throughout the day
Intensity
11 and 13 on the RPE scale
Speed
Comfortable walk/cycle
Frequency
4 -5 times per week
WEEK 11-12
AEROBIC:
Type
Walking, bike
Duration
180% - 200% of time achieved at initial assessment
NB: aerobic exercise can be broken down into intervals,
aiming for 30mins (20-60 mins) continuous exercise
minimum of 10 min bouts accumulated throughout the day
Intensity
11 and 13 on the RPE scale
Speed
Comfortable walk/cycle
Frequency
4 -5 times per week
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1.
Range of motion exercises
Active range of motion exercises are continued on from motor relearning phase of training
•
Cervical AROM spine exercises should include active exercises for the cranio-cervical, cervical and cervico-thoracic
regions
•
Muscle stretching exercises (e.g.. pecs)
•
AROM upper limb exercises emphasising scapular stability.
2.
Muscle strength and endurance exercises, higher level sensorimotor exercises
These exercises progress from the motor relearning phase and incorporate general strengthening exercises for other body
regions.
In all upper and lower limb exercises, the participant concentrates on maintaining a neutral spinal position and in upper
limb exercises, focuses on scapular control.
• Neck flexor and extensor strengthening.
• Rotator cuff, Biceps, triceps, trapezius (all three parts) strengthening exercises.
• Glut med exercises, squats, calf raises (emphasis on whole body).
• Balance / coordination /kinaesthetic training.
Baseline assessment for strength and endurance exercises
Modify the test position or cease test if the participant complains of excessive discomfort or pain (≥ 2 on 0-10 VAS) in
any test.
(i) Cervical flexor strength and endurance assessment
Determine the head flexion load that the participant can perform 12 times.
Protocol
- Participant supine in crook lying position with the head on two pillows.
- Hands resting on their abdomen.
- In performing head and neck flexion, the participant should be instructed to flex the cranio-cervical region to a
comfortable range and maintain the chin position while they lift their head attempting 12 repetitions.
- Loss of cranio-cervical position is failure in the test.
- If the participant cannot perform 12 head lifts on two pillows, position them in reclined lying position, such that they
can achieve 12 repetitions.
- If the participant can achieve 12 repetitions on 2 pillows, progress test to one pillow and then to no pillow (do tests of
other muscles in between repeated tests to gain baseline for cervical flexor exercise)
(ii) Cervical extensor strength and endurance assessment
Determine the head extension load that the participant can perform 12 times.
Protocol
- Participant lies prone on the therapy table with their head and cervical spine unsupported. Arms are by the
participant’s side with their hands by their hips.
- Test range is from 20º flexion to maximum achievable extension. Cranio-cervical region is maintained in a neutral
position and the action is a curl into flexion and a curl into extension. The position of the cranio-cervical region can be
maintained in neutral by instructing the participant to keep their eyes focussed on an imaginary book on the floor.
- Perform test with no added load in the first instance.
- For added load suspend weights on a helmet and progress in increments of 0.5Kg to determine baseline.
(iii) Upper and lower limb strength and endurance exercises
•
•
Rotator cuff, Biceps, triceps, trapezius (all three parts) strengthening exercises.
Glut med exercises, squats, calf raises.
Determine the load that the participant can perform 12 times for the respective exercise/muscle group.
- Set the participant up in the starting position. Emphasise correct spinal posture and scapular control (as per specific
exercise protocol).
- Select an approximate weight or theraband that would equate to approximately 12RM for upper limb exercises.
- Increase or decrease the load as required.
- Establish the weight that the participant can lift 12 times and fatigues for the baseline.
- Determine repetitions for lower limb exercises.
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(iv) Higher level sensorimotor exercises
Document level the participant has achieved at week 4 and progress from this point to higher level of exercise e.g.
increased complexity of task, combinations.
Page 90 of 102
Guide to Graded Exercise Program Progression
The graded exercise program is to be performed 4-5 times per week.
WEEK 5-6
NECK MUSCLE ENDURANCE AND STRENGTH:
Position: on 2 pillows (or position achieved at
Neck flexor strength and endurance
(head lift exercise)
baseline)
Repetitions: 10 reps (building to 15 reps over first two
weeks
Position: prone head off end of plinth
Neck strength and extensor endurance
Repetitions: 10 reps (building to 15 reps over first two
weeks with the baseline load
UPPER LIMB ENDURANCE
focus on scapular stability and spinal posture during activity
Sh Abduction
Week 5:
Biceps
Load: 80% of baseline 15RM
Triceps (weights or push downs)
Repetitions: 15
Sets: 1-2
Week 6:
Load: increase by 10%
Repetitions: 15; Sets: 2-3
Rot cuff - ER in sitting
Using theraband
Load: 80% baseline 15RM
Sets: 1-2
Position: side lying set scapula
Rot cuff - ER in side lie
Weights: Load: 80% baseline 15RM
Movt: ER from inner range to neutral
Sets 1-2
Week 6
Load: increase by 10%
Repetitions: 15; Sets: 2-3
Push ups
Load: Begin with scapula control in closed chain under
low load (e.g. push ups on wall)
Reps: 15; Sets: 1-2
LOWER LIMB ENDURANCE
focus on maintenance of trunk stability during activity
Calf raises
Week 5:
Load: 80% of baseline repetitions
Squats (to depth achievable)
Sets: 1-2
Week 6:
Increase by 10%
Sets: 2-3
Glut medius (clam in side lie)
Load: 80% of baseline repetitions
Sets: 1-2
Glut medius (hip hitch in stand)
Position: 80% of baseline repetitions
Sets: 1-2
Sensorimotor training: refer to progressions described in the motor relearning program. Increase complexity of
exercises for balance, eye follow and kinaesthetic sense. Do combinations of exercises
WEEK 7-8
NECK MUSCLE ENDURANCE AND STRENGTH:
Position: on 2 pillows (or position achieved at
Neck flexor strength and endurance
(head lift exercise)
baseline)
Repetitions: progress to 2 then 3 sets of 15 repetitions
of the initial 12 repetitions maximum load.
Neck strength and extensor endurance
Position: prone head off end of plinth
Repetitions: progress to 2 then 3 sets of 15 repetitions
with load as per
weeks 5-6
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UPPER LIMB ENDURANCE
focus on scapular stability and spinal posture during activity
Sh Abduction
Load: Load: increase to 20%-30% above starting
Biceps
load, increase theraband colour
Triceps (weights or push downs)
Repetitions: 12-15; Sets: 3
Rot cuff - ER in sitting
Rot cuff - ER in side lie
Push ups
LOWER LIMB ENDURANCE
focus on maintenance of trunk stability during activity
Calf raises
Squats (to depth achievable)
Glut medius (clam in side lie)
Load: Load: increase to 20%-30% above starting
load, increase theraband colour
Repetitions: 12-15; Sets: 3
Load: Load: increase to 20%-30% above starting
load, increase theraband colour
Repetitions: 12-15; Sets: 3
Load: Increase to moderate load (e.g. push ups on an
incline)
Reps: 15; Sets: 3
Repetitions: 15; Sets: 3
Repetitions: 15; Sets: 3
Glut medius (hip hitch in stand)
Sensorimotor training: refer to progressions described in the motor relearning program. Increase complexity
of exercises for balance, eye follow and kinaesthetic sense. Do combinations of exercises.
WEEKS 9-10
NECK MUSCLE ENDURANCE AND STRENGTH:
Position: progress to 1 pillows (or progress position
Neck flexor strength and endurance
(head lift exercise)
achieved at baseline)
Repetitions: 2 then 3 sets of 15 repetitions
Position: prone head off end of plinth
Neck strength and extensor endurance
Repetitions: increase load by 20-30%
Repetitions: 3 sets of 15 repetitions
UPPER LIMB ENDURANCE focus on scapular stability and spinal posture during activity
Sh Abduction
Load: Load: increase by 20%-30%, increase
Biceps
theraband colour
Triceps (weights or push downs)
Repetitions: 12-15
Sets: 3
Rot cuff - ER in sitting
Rot cuff - ER in side lie
Push ups
Load: Load: increase to 20%-30% above starting
load, increase theraband colour
Repetitions: 12-15
Sets: 3
Load: Load: increase to 20%-30% above starting
load, increase theraband colour
Repetitions: 12-15
Sets: 3
Load: Increase to high load (e.g. push ups or half
push-ups on the floor)
Reps: 10-15reps
Sets: 3
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LOWER LIMB ENDURANCE
focus on maintenance of trunk stability during activity
Calf raises
Progress to single leg calf raises
Repetitions: 15
Sets: 3
Squats (to depth achievable)
Repetitions: 15
Sets: 3
Glut medius (clam in side lie)
Place further into ¾ prone
Repetitions: 15
Sets: 3
Glut medius (hip hitch in stand)
Repetitions: 15
Sets: 3
Sensorimotor training: refer to progressions described in the motor relearning program. Increase complexity of
exercises for balance, eye follow and kinaesthetic sense. Do combinations of exercises.
WEEKS 11-12
NECK MUSCLE ENDURANCE AND STRENGTH:
Position: progress to no pillows (or progress position
Neck flexor strength and endurance
(head lift exercise)
achieved)
Repetitions: 2 then 3 sets of 15 repetitions
Neck strength and extensor endurance
Position: prone head off end of plinth
Repetitions: increase load by 20-30%
Repetitions: 3 sets of 15 repetitions
UPPER LIMB ENDURANCE focus on scapular stability and spinal posture during activity
Sh Abduction
Load: Load: increase by 20%-30%, increase
Biceps
theraband colour
Triceps (weights or push downs)
Repetitions: 12-15; Sets: 3
Rot cuff - ER in sitting
Rot cuff - ER in side lie
Push ups
LOWER LIMB ENDURANCE
focus on maintenance of trunk stability during activity
Calf raises
Squats (to depth achievable)
Glut medius (clam in side lie)
Load: Load: increase to 20%-30% above starting
load, increase theraband colour
Repetitions: 12-15; Sets: 3
Load: Load: increase to 20%-30% above starting
load, increase theraband colour
Repetitions: 12-15; Sets: 3
Load: Increase to high load (e.g. push ups or half
push-ups on the floor)
Reps: 10-15reps; Sets: 3
Progress to single leg calf raises
Repetitions: 15; Sets: 3
Repetitions: 15; Sets: 3
Place further into ¾ prone
Repetitions: 15; Sets: 3
Repetitions: 15; Sets: 3
Glut medius (hip hitch in stand)
Sensorimotor training: refer to progressions described in the motor relearning program.
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4. Functional exercises
Guiding principles to functional exercises:
1.
These exercises should be functional and participant specific - identified from the PSFS. The manner in which the
functional exercises are trained will depend on the treating physiotherapist’s own clinical judgement and may involve
part practice or whole task practice. The emphasis is on achieving the functional goal and assisting the participant in
completing these activities in everyday life. The exercise program should be compatible with and reflect their
functional goals and their current abilities.
2.
Functional exercises that may be relevant to the participant could include:
- Computer work
- Driving
- Overhead work
- Carrying
- Lifting
- Pushing/pulling
- Sport specific activities
3.
Ergonomic advice and rehabilitation of the functional tasks that the participant has identified will have likely begun in
the initial 4 weeks of training. At this stage of training, emphasis is placed on further improving their functional
capacity.
4.
As the participant’s exercise capacity improves it is important to gradually increase the complexity of the training
activity until eventually the participant is able to perform the goal ADL activity. Complexity of a training exercise may
be increased by:
- Increasing endurance for the task
- Increasing the load
- Increasing the number of repetitions
- Increasing the speed of movement
- Increasing balance requirements
- Performing concurrent tasks; linking tasks
5.
Training of functional capacity is commenced at 80% of the participant’s capacity and the principles of pacing and
exercise quotas are used for progression of exercise. Progressions should be in 10% to 20% increments every 2 weeks
of training.
Examples of baseline assessment for lifting and carrying tasks
• Horizontal lift - Lift milk crate from waist level shelf, move horizontally 4 feet put crate down again. Repeat five
times. Scored as maximum safe lifted weight.
• Front carry - Lift milk crate off floor or waist height bench, carry milk crate 25 feet forward and then return back to
floor or bench. Recorded as maximum safe lift.
• (R) or (L)-handed carry - Lift container with handle off waist height bench, carry container 25 feet forward and then
return back to bench. Recorded as maximum safe lift.
• Loaded reach - Participants stand next to a wall on which a meter rule was mounted at shoulder height. They
reached forward at shoulder height, holding a weight that does not exceed 5% of body weight or 4.5kg. The
maximum reach distance recorded in cm.
• Dynamic push/pull - Ability to push a weighted trolley 25 feet and then reverse and pull 25 feet back to the start
position. Scored as maximum weight safely moved.
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SAFETY CONSIDERATIONS
INDICATORS TO CEASE EXERCISE
Adapted from the ACSM general indications for stopping an exercise test in low-risk adults:
- Onset of angina or angina-like symptoms.
- Signs of poor perfusion: light headedness, confusion, ataxia, pallor, cyanosis, nausea or cold and clammy skin.
- Failure of heart rate to increase with increased exercise intensity.
- Physical or verbal manifestations of severe fatigue.
- Participant requests to stop (ascertain reason for discontinuation i.e. psychophysical end point (voluntary test termination
due to excessive fatigue or discomfort), aerobic end point (85% of age determined ‘maximum heart rate’) or pain
(increase in pain intensity by 2 or more points on 10 point scale).
- Significant drop (20mmHg) in systolic blood pressure or failure of the systolic blood pressure to rise with an increase in
exercise intensity.
- Excessive rise in blood pressure: systolic pressure > 260mmHg or diastolic > 115mmHg.
- Failure of the testing equipment.
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Appendix 7
Cognitive – Behavioural Principles
Summary
Individuals learn most effectively by doing. Providing information or simply telling someone what to do is a much less
effective method of training. During the implementation of these principles it is envisaged that individuals are taught the
exercises and become increasingly self reliant and motivated.
Shaping is a technique which can assist an individual in achieving a specific activity or behaviour that they currently do
not exhibit. It is a gradual process, where initially the individual approximates the target activity/behaviour to the best of
their ability. Repetition of the activity allows for it to be refined and reinforced until the target activity/behaviour can be
performed. Thus, a perfect performance is not expected or required initially however is expected to be developed over
time.
Reinforcement occurs when an event following an activity or behaviour increases the likelihood that that activity or
behaviour will be repeated in the future. Reinforcers can be thought of as a reward, something that the individual wants to
achieve and will therefore work towards. They can be external (e.g. charting progress, praise or feedback) or internal (e.g.,
sense of personal achievement) and they do not need to occur every time the activity or behaviour (or a similar activity or
behaviour) occurs however just often enough that the individual continues the desired behaviour.
For reinforcements to be effective it is important that they are:
- Consistent i.e. the same activity or task is reinforced in a consistent manner.
- Reinforced by the individual themselves i.e. the individual is able to acknowledge what they have done and take
credit for their achievements. The ultimate aim is to increase the individual’s self-reliance and ability to implement
the principles in order to achieve the goals which are important to them.
- Considered to be important to the individual and are potent enough to be a meaningful reward. It is important the
individual plays an active role when identifying possible reinforcers for themselves as no-one is likely to work for
something they don’t really want to achieve.
- Provided as soon as possible following the behaviour e.g., immediate feedback after a performance is more effective
than delayed feedback.
- Achievable. Short term reinforcers can be used to monitor and reward progress which is required to achieve the longer
term goals. Long-term reinforcers will usually be the goal(s) aiming to be achieved.
- Progressive i.e. initially it is useful to make the reinforcers or goals easy to achieve as this will assist to encourage and
motivate the individual to continue the behaviour. Then as the individual regularly achieves the goal then the task can
be made more difficult. Completion of a task can act as a reinforcer itself however it is good to augment this with an
external or internal reinforcer.
Goal setting: Goals can also act as reinforcers as there is a sense of achievement associated with goal attainment and the
individual’s behaviour is reinforced and they can further act as a motivator to achieve more. Ideally, clearly defined goals
are of most use i.e. specific, measurable, achievable, realistic and time-based goals.
Quotas and pacing
When setting an exercise quota it is vital that it is set below the individual’s current activity tolerance and therefore
achievable while also not aggravating their symptoms. Fordyce (1976) suggest starting setting the initial quota 20% below
what the individual can achieve during the baseline assessment. Once the quota and progressive increments (pacing) are
determined it is important that the individual adheres to the program and does not under or overdo the amount of activity
prescribed e.g., on a day when their pain in worse it is important that the prescribed amount of exercise is completed
despite the extra pain however other pacing strategies can be applied e.g. increasing the number of rest periods between
exercises or changing task frequently. However, this does not apply to the motor relearning program of the first 4 weeks,
where it is important that these exercises are pain free (see Motor Relearning Program section). If the individual reports
that the program is difficult and exacerbates their pain, the set quota may have been too ambitious and should be reviewed
and re-set if necessary. If the program continues to be difficult and the individual repeatedly stops short of the quota then
the quota may have to be re-set.
By setting quotas for exercise the participant has an external goal to aim for taking the focus away from their pain. It is
important that the individual understands that the amount of activity is progressed in a time-contingent manner and they
do no more on a good day and no less on a bad day.
Association effects (Reminders): an exercise program is more likely to be completed if it can be tied to (associate the
exercises) with specific times or places. Prior to the individual leaving the clinic it is advised that they have a specific plan
for when they will do their exercises and how best they can fit their exercises into their current routine. Reminders or
Page 96 of 102
triggers such as a note on the fridge or sticker on a wrist watch can be useful to improve our memory of when to do
exercise.
Overcoming fear avoidance responses through graded exposure and addressing individual’s
thoughts/beliefs/expectations. A key element in managing an individual’s fear or avoidance of activity is identifying the
specific factors or thought processes limiting them from participating in the activity/exercise and correcting or clarifying
these thoughts. It is important that education and reassurance is given as factual and specific as possible and vague or
anxiety-inducing responses such as ‘let pain be your guide’ are avoided. It is important to encourage the individual to
resume feared activities and when approached in a gradual and paced manner, exacerbations of symptoms are minimised
and functional goals can be achieved.
Adapted from:
Chapter by MK Nicholas and L. Tonkin in Musculoskeletal Physiotherapy: Clinical Science and Evidence-based Practice.
K. Refshauge and E. Gass (eds). Butterworth Heinemann, Oxford, 2nd ed. 2004
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Appendix 8
Participant Proforma
Please see the separate attachment
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CHRONIC WHIPLASH EXERCISE TRIAL
SENSORIMOTOR EXERCISES
1. HEAD REPOSITIONING TO
NEUTRALEXERCISE: ROTATION
Place the headband with laser attached on your head. Place the target pattern on
the wall one metre away in line with the laser. Sit and focus on the bullseye point
on the wall straight in front of you. Close your eyes and rotate your head as far as
you can to the left/right. Try and return to the starting position as accurately as
you can, open your eyes to see how accurate you have been.
4.
Repeat ____ times up to 5
2. HEAD REPOSITIONING TO NEUTRAL EXERCISE: FLEXION AND
EXTENSION
Sit and focus on the bullseye point on the wall straight in front of you. Close your
eyes and take you head as far as you can forwards /backwards. Try and return to
the starting position as accurately as you can, open your eyes to see how accurate
you have been.
Repeat ____ times up to 5
3. HEAD REPOSITIONING TO POINTS IN RANGE EXERCISE:
ROTATION
Place dots 20 centimetres apart across the wall. Place the headband with laser
attached on your head. Sit, close your eyes and rotate your head to find each dot as
accurately as you can, open your eyes to see how accurate you have been.
Repeat ____ times up to 5
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CHRONIC WHIPLASH EXERCISE TRIAL
SENSORIMOTOR EXERCISES
4. HEAD REPOSITIONING TO POINTS IN RANGE: FLEXION AND
EXTENSION
Place dots 20 centimetres apart vertically on a wall. Place the headband with laser
attached on your head. Sit, close your eyes and move your head forward or
backwards to find each dot as accurately as you can, open your eyes to see how
accurate you have been.
Repeat ____ times up to 5
5. HEAD TRACKING ACTIVITY
Sit and place the headband with laser attached on your head. Place the figure of
eight pattern on the wall in line with the laser. With your eyes open, move your
head to trace the pattern with the light. Try to be as accurate as possible.
Repeat ____ times up to 5
You can make these more difficult by
•
•
•
Increasing the speed of movements
Performing the activities while sitting on an unstable surface such as a
therapy ball
Performing the activities while standing with feet in an unstable base of
support e.g. heel toe
6. GAZE FIXATION WITH HEAD MOVEMENT
Sit on a chair and fixate your gaze on a dot straight in front of you. Keep the target
in focus, while you move your head to the left, right, back and forwards.
Repeat each movement ____ times, twice a day
You can make this more difficult by
Increasing the speed and range of movements
Adding a busy pattern (e.g. stripes or checks) to the background of the
visual target or making the target a word/business card to keep in focus
rather than just a spot.
• Performing the activities while sitting on an unstable surface such as a
therapy ball
Performing the activities while standing with feet in an unstable base of support
e.g. heel toe, or while walking.
•
•
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CHRONIC WHIPLASH EXERCISE TRIAL
SENSORIMOTOR EXERCISES
7. EYE/HEAD CO-ORDINATION
Sit and rotate the eyes and head to the same side, left and right.
Sit and move your eyes first to 30 degrees to the left or right keeping your head
still, keep focused and then move your head to that point. Bring eyes back to
centre (head still) and then move head back.
Sit and rotate your eyes and head to the opposite side, left and right. Repeat each
exercise 5 times, twice a day.
Move hand, arm, head and trunk following with the eyes
8. EYE FOLLOW WITH THE HEAD STILL
Keep your head still and follow a moving target with your eyes, side to side and
up and down. Keep your head still and then rotate your trunk to the left/ right.
Keep the head still and repeat following the moving target with the eyes, side to
side/ up and down
Repeat each exercise 5 times, twice a day.
To make a moving target, you can shine a laser light onto the wall in front of you
and move the laser with your hand.
9. BALANCE
Standing with your feet in comfortable, narrow, tandem, single leg stance
Maintain your balance for 30 seconds with your eyes open/closed
firm/ soft surface
You can progress the exercises by
•
•
•
•
•
Comfortable/Narrow/Tandem
Changing your foot position
Eyes closed
Soft surface
Walking with head movements (rotation, flexion and extension) while
maintaining direction and speed of walking
Performing your eye and head exercises whilst balance training
Exercise progressions:
eyes closed/ soft surface
Page 101 of 102
Web appendix 3:
Sensitivity analysis using imputed values. Treatment effects, mean (95%CI) at 3, 6 & 12 months
Clinically
worthwhile
effect
PRIMARY OUTCOME
Pain over previous weeka
Replace missing values in both groups
with “0”
Replace missing values in both groups
with “10”
Replace advice missing value with ‘0’
and exercise missing value with ‘10’
Replace advice missing value with ‘10’
and exercise missing value with ‘0’
2.0
14 weeks
6 months
12 months
0.0 (-0.7 to 0.7)
p = 0.97
0.2 (-0.5 to 1.0)
p =0.544
-0.4 (-1.3 to 0.6)
p = 0.456
-0.8 (-1.7 to 0.0)
p = 0.057
0.7 (-0.1 to 1.6)
p = 0.094
0.2 (-0.5 to 1.0)
p = 0.537
0.5 (-0.3 to 1.3)
p= 0.237
0.1 (-0.8 to 1.2)
p = 0.784
-1.2 (-2.1 to -0.3)
p = 0.006
1.8 (1.0 to 2.7)
p =0.000
-0.1 (-0.8 to 0.6)
p = 0.967
0.0 (0.8 to 0.8)
p = 0.967
-0.2 (-1.1 to 0.7)
p =0.655
-1.3 (-2.2 to -0.4)
p = 0.003
1.1 (0.3 to 2.0)
p = 0.011
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