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Function after spinal treatment, exercise and rehabilitation (FASTER): A factorial randomised trial to
determine whether the functional outcome of spinal surgery can be improved.
Alison H McGregor1*, Caroline J Doré2, Tim P Morris3, Steve Morris4, Konrad Jamrozik5 on behalf of
the FASTER team
Author for correspondence: Alison McGregor
1 Alison H McGregor, Surgery & Cancer, Faculty of Medicine, Imperial College London, Charing Cross
Hospital Campus, London W6 8RP
a.mcgregor@imperial.ac.uk
Phone +44(0)203 313 8831
Fax +44(0)203 313 8835
2 Caroline J Doré, MRC Clinical Trials Unit, 222 Euston Road, London NW1 2DA
c.dore@ctu.mrc.ac.uk
3 Tim P Morris, MRC Clinical Trials Unit, 222 Euston Road, London NW1 2DA
tpm@ctu.mrc.ac.uk
4 Steve Morris, Department of Epidemiology and Public Health, University College London, London
WC1E 6BT
steve.morris@ucl.ac.uk
5 Konrad Jamrozik, School of Population Health and Clinical Practice Office, North Terrace, University
of Adelaide, SA 5005, AUSTRALIA
konrad.jamrozik@adelaide.edu.au
Trial Registration
Current controlled trials ISRCTN46782945 / UK CRN ID: 2670
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Acknowledgements
This study was supported by Arthritis Research UK
We would like to thank all the patients for making this study possible and their patience with the
many questionnaires involved in this study and the FASTER team for making this study possible.
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FASTER TEAM
Trial Steering Committee
Professor Jeremy Fairbank
Mrs Caroline Doré
Lord ER Oxburgh
Professor Jennifer Klaber Moffett
Mr Steve Eisenstein
Mr Tim Morris
Professor Alison McGregor
Trial Coordinator – see below
Trial Management Team
Principle investigator: Alison McGregor
Trial Coordinators: Ania Henley, Jack Kerr, Dr Julia Toschke
Physiotherapy Coordinators: Carla Ashford, Janet Deane, Carol Waugh
Data Monitoring & Ethics Committee
Professor Sarah Hewlett
Dr Simon Bowman
Dr Martyn Lewis
Participating Hospitals
Charing Cross Hospital
Guy’s and St Thomas’ Hospital
Heatherwood Hospital
Ravenscourt Park Hospital
Royal Free Hospital
St Mary’s Hospital
Wexham Park Hospital
Contributing Surgeons
Mr M Akmal
Mr N Anjarwalla
Mr R Bradford
Mr N Dorward
Mr T Ember
Mr D Fahy
Professor S Hughes
Mr J Johnson
Mr K Lam
Mr J Lucas
Mr N Mendoza
Ms M Murphy
Mr D Nandi
Mr J O’Dowd
Mr K O’Neill
Mr D Petersen
Mr C Shieff
Mr L Thorne
Mr C Ulbricht
Professor J van Dellen
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Trial Physiotherapists
Katie De Albuquerque
Nathan Allwork
Hayley Boyle
Ann Bryan
Rachel Freeman
Jenny Heal
Annys Hawkins
Catherine Heathcote
Frances Honniball
Gary Jones
Biljana Kennaway
Gemma Kettle
Anna Kuppuswamy
Claire Marshall
Ann McCarthy
Hannah Mundy
Sandra Noonan
Sara Parker
Camilla Pleydell-Bouverie
Rebecca Portwood
Amy Powel
Adam Royffe
Victoria Salmon
Laura Segar
Alison Sentence
Tom Stenning
Hillary Thompson
Lorraine Tomeldan
Amanda Wall
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Structured Abstract
Study Design
This was a multi-centre, factorial, randomised controlled trial on the post operative management of
spinal surgery patients, with randomisation stratified by surgeon and operative procedure.
Objective
This study sought to determine whether the functional outcome of two common spinal operations
could be improved by a programme of post-operative rehabilitation that combines professional
support and advice with graded active exercise commencing 6 weeks after surgery and/or an
educational booklet based on evidence-based messages and advice received at discharge from
hospital, each compared with usual care.
Summary of background data
Surgical interventions on the spine are increasing, and whilst surgery for spinal stenosis and disc
prolapse have been shown to be superior to conservative management, functional outcome and
patient satisfaction are not optimal.
Methods
The study compared the effectiveness of a rehabilitation programme and an education booklet for
the postoperative management of patients undergoing discectomy or lateral nerve root
decompression surgery, each compared with “usual care” using a 2 x 2 factorial design, randomising
patient to four groups; rehabilitation-only, booklet-only, rehabilitation-plus-booklet, and usual care
only. The primary outcome measure was the Oswestry Disability Index (ODI) at 12 months, with
secondary outcomes including visual analogue scale measures of back and leg pain.
Results
338 patients were recruited into the study and measurements were obtained pre-operatively and
then repeated at 6 weeks, 3, 6, 9 and 12 months post-operatively. Twelve months post operatively
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the observed effect of rehabilitation on ODI was -2.7 (95% CI -6.8 to 1.5) and the effect of booklet
was 2.7 (95% CI -1.5 to 6.9).
Conclusions
This study found that neither intervention had a significant impact on long term outcome.
Key words
Randomised controlled trial; post-operative management; rehabilitation; education; factorial
Mini abstract
This randomised controlled trial explored 4 different approaches to the post-operative management
of spinal decompression and discectomy surgery. 338 patients were recruited and followed over a
one year period using measures of function, pain, and health related quality of life.
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Introduction
Spinal surgery rates have increased across the world 1;2, particularly surgery for spinal stenosis which
in part reflects the growth in the elderly population3. This study focuses on spinal discectomy
surgery for a herniated lumbar intervertebral disc and nerve root decompression surgery for lumbar
spinal stenosis, two of the commonest spinal procedures performed1;4;5. Both procedures are
deemed superior to conservative treatment although the benefits are known to diminish with time1.
However, functional improvement and patient satisfaction are varied; in decompression surgery
success rates range between 58-69%5-7 and satisfaction from 15-81%2;8;9; and for discectomy success
rates ranged between 65-90%2;10;11, with less known regarding patient satisfaction.
Consequently, this study sought to improve the functional outcome and patient satisfaction
following spinal surgery by addressing post-operative recovery. Further rationale for study has been
previously published12. Briefly, it builds upon survey findings and literature reviews of post-operative
management which identified wide variations in practice amongst surgeons, indicative of
uncertainty which was further supported by a lack of evidence to justify many of these practices 13-17,
and a growing literature base highlighting muscle dysfunction in spinal patients18;19 and subsequent
damage to the muscles with surgery20;21. Two approaches to addressing this were identified; formal
rehabilitation and educational material to encourage self-management. A systematic review of
rehabilitation following lumbar disc surgery22 provided evidence that rehabilitation could enhance
outcome, and subsequently a number of small studies23-28 reported mixed findings. Similarly
educational material has been found to have an impact on patient outcome24;29;30. However, many of
these studies were underpowered, or of poor design with few comparing the interventions to usual
care.
The objective of this factorial randomised controlled trial (FASTER ~Function after spinal
treatment, exercise and rehabilitation) was to evaluate the benefits of a rehabilitation programme
and an education booklet for the postoperative management of patients undergoing discectomy or
lateral nerve root decompression, each compared with “usual care”. Our hypothesis is that a
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programme of post-operative rehabilitation that combines professional support and advice with
graded exercise will improve the long-term outcome of surgery, and that appropriate educational
information will also improve outcome but to a lesser degree than rehabilitation. We assume that
the effect of the combination of the two interventions will be additive i.e., there will be no
interaction.
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Methods
FASTER is a multi-centre, parallel group, factorial, randomised controlled trial which aims to
determine the optimal post-operative management strategy following spinal surgery12. The study
was approved by Hammersmith and Queen Charlotte’s & Chelsea Hospitals Research Ethics
Committee, with site approval for 7 hospitals in the West London Region. Patients presenting with
symptoms, signs, and radiological findings of either lateral nerve root compression or disc prolapse
scheduled for surgery were recruited and consented into this study and randomised using a 2 x 2
factorial design to receive:

Factor 1 – either a six-week programme of post-operative rehabilitation or the relevant
surgeon’s usual postoperative care (according to the surgeon’s discretion and routine
practice):

Factor 2 – either an educational booklet (“Your Back operation” 31), or the surgeon’s usual
advice.
This created four study groups; rehabilitation-only, booklet-only, rehabilitation-plus-booklet, and
usual care only. Allocation to a study group was by central telephone randomisation stratified by
surgeon and surgical procedure using random permuted blocks to ensure that each participating
surgeon and each surgical procedure had approximately equal numbers of patients allocated to each
group. Treatment allocation was concealed prior to surgery to avoid selection bias during
recruitment. Patients were notified of their randomisation following their surgery and those
patients allocated to either the booklet-only group or the rehabilitation-plus-booklet group received
the booklet entitled “Your Back operation” 31 on discharge. Patients were assessed using a range of
validated outcome measures pre-operatively and then at 6 weeks, 3, 6, 9 and 12 months postoperatively.
Study population
Patients were recruited by the trial coordinator from the surgical waiting lists of the contributing
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surgeons (20 in total; 8 orthopaedic and 12 neurosurgical) at the different hospital sites and written
informed consent obtained. Eligible patients included those awaiting spinal surgery with either (a)
signs, symptoms and radiological evidence of lateral nerve root compression, that is, patients
presenting with radicular pain with an associated neurological deficit or with neurogenic
claudication (pain in the buttock, thigh or leg that improves with rest), or (b) lumbar disc prolapse,
that is, patients with root symptoms and signs and MRI confirmation of lumbar disc herniation.
Patients presenting with any of the following were excluded from participation; any condition where
either the intervention or the rehabilitation may have an adverse effect on the individual; previous
spinal surgery; spinal surgery where a fusion procedure was planned due to the unknown hazards of
the activity programme for this type of surgery; pregnant women; inadequate ability to complete
the trial assessment forms; unable to attend or unsuitable for rehabilitation classes. Following poor
compliance with return of baseline forms at the start of the trial, patients were only allocated a trial
number and treatment group after successful completion of these forms; those not complying were
removed from the trial.
Trial Interventions
Surgical Intervention: Participants underwent spinal surgery according to their surgeon’s routine
practice for that condition and the surgical details were recorded.
Rehabilitation Programme: Patients in the rehabilitation arms were invited to commence the
intervention 6 to 8 weeks following their surgery. The programme comprised 12 standardised one
hour classes run twice weekly by an experienced physiotherapist. They included general aerobic
fitness work; stretching; stability exercises; strengthening and endurance training for the back,
abdominal and leg muscles; ergonomic training; advice on lifting and setting targets; and selfmotivation along with an open group discussion at the end of each class. Compliance was based on
attendance records, and the quality and content of the classes were reviewed regularly. Any
clustering effects due to therapist or treatment centre were considered negligible due to the large
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number of physiotherapists running classes, thus patients were routinely crossing between
therapists.
Educational Booklet: Patients in the booklet arms received a copy of “Your Back operation” 31 on
discharge from hospital. The design and content of which have been previously reported32.
Usual care: Patients receiving usual care were managed according to the relevant surgeon’s usual
practice. Previous work has shown this to be varied and limited13.
Outcome Measures
The Oswestry Disability Index (ODI, version 2.1a), a disease-specific validated patient-completed
questionnaire documenting function33;34 was the primary outcome measure. It is scored from 0-100
and interpreted as a disability percentage with lower scores representing lower levels of disability.
Secondary outcome measures included 10cm visual analogue scales (VAS) which recorded average
back and leg pain35, which were expressed as a percentage with a lower score indicative of less pain;
the hospital anxiety and depression (HADS) questionnaire recorded anxiety and depression with
scores between 0-21 - where higher values represent a greater level of anxiety /depression36; the
Fear Avoidance Beliefs Questionnaire (FABQ) was used to assess pain behaviours giving scores
between 0-24 with higher scores representing stronger fear avoidance beliefs 37; the EQ-5D was
used to determine Health Related Quality of life, the thermometer of the score was used to assess
health which was rated between 0-100 with 100 representing a perfect health state38;39; and return
to work. Following recent findings the relative severity of low back pain to leg pain was also
determined (Average leg pain minus average back pain)40. Baseline information was captured on the
participant’s occupation, working and marital status, ethnicity, age, body mass index, and smoking
habits. Measures of patient expectations and satisfaction were also obtained, and a full economic
analysis performed the results of which will be reported separately. It was not possible to assess
outcome measures blind to the randomised intervention since all outcome measures are patient
assessments.
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Sample size
The trial aimed to recruit 344 patients with 86 patients in each of the 4 interventions12. This
calculation was based on a 90% chance of detecting a 20% relative improvement in the ODI
corresponding to a between-group difference of 8 points in the ODI and declaring it statistically
significant using a two-sided alpha= 0.05. This calculation assumed a standard deviation of 20 in
each group and allowed for loss to follow up of 23%, as seen in earlier descriptive work41.
Statistical Analysis
This was performed according to our protocol12. Initially a descriptive comparison of the trial groups
before surgery was done to confirm that randomisation had produced balanced groups with respect
to known predictors of outcome such as age, sex, type of surgery, ethnic background, marital status,
body mass index, occupation type, work status and smoking status. Baseline characteristics are
summarised across the four groups as no. (%) for categorical variables or mean (sd) for continuous
variables. Baseline values of outcome scores – including ODI, average back pain, average leg pain,
FABQ, HADS and VAS health summary – were summarised as mean (sd) if approximately normal.
The primary outcome was the between-group difference in score on the ODI at one-year
follow up, based on intention-to-treat. Secondary outcomes included average back and leg pain,
FABQ, HADS anxiety & depression scores and VAS for overall health (all measured at one year follow
up). Groups were compared using analysis of covariance adjusting for baseline value of outcome and
stratifying factors: surgery type as a fixed effect and surgeons as random effects, to increase
efficiency in estimating the effect of intervention. Analyses were performed for booklet vs. nobooklet and rehabilitation vs. no-rehabilitation simultaneously. Comparisons were followed by a test
for interaction of the two interventions.
Some participants missed their final visit but did attend one or more post-baseline reviews.
Multiple imputation using chained equations was used assuming unobserved measurements were
missing at random. The imputation model included baseline and follow up values of outcomes,
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intervention group, recruiting centre, type of surgery, weight, height, sex and age. 20 cycles of
chained equations were run before an imputed dataset was saved. 10 such datasets were generated
and analyses performed on each of these 10 datasets. Estimates from the 10 analyses were
combined using Rubin’s rules42. Complete cases were analysed to verify that inferences obtained
from imputed data were consistent.
A longitudinal analysis was performed using all follow up data to investigate change in
outcomes over time. A transformation of time (time-2) was used to allow for the non-linearity of
changes over time. The longitudinal linear mixed model included baseline, random intercepts and
coefficients for patients, and stratifying factors as above. The parameters of interest were
intervention-by-time interactions.
We investigated possible interactions of treatment effects with type of surgery (lateral nerve
root decompression or discectomy), baseline body mass index, baseline HADS score and baseline
ODI. Further, the longitudinal analysis was extended to look at ODI and secondary outcomes over
time by surgical procedure.
Results
Figure 1 Consort Diagram
Recruitment occurred between June 2005 and March 2009, at 7 hospitals and 1288 patients were
approached; 124 did not meet the inclusion criteria, and 363 were enrolled, 25 were dropped due to
failure to complete baseline forms. Reasons for non-participation varied and included general apathy
(24%), language issues (4%), inability to travel to classes (26%), and cancellation of operative
procedure (31%). Figure 1, depicts the flow of patients through the study.
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Table 1 ~ Baseline characteristics of study population (as number (%) for categorical variables or
mean (sd) for continuous variables)
The baseline characteristics are summarised in Table 1. Baseline values of outcome scores –
including ODI, average back and leg pain, FABQ, HADS, VAS health summary and EQ5D summary
score are summarised in Table 2. The four groups were similar at baseline. Return to work was found
to be an unreliable outcome due to the large number of participants not working at baseline, and is
not reported.
Table 2~ Baseline values of primary and secondary outcomes (mean (sd))
Compliance
In participants allocated to rehabilitation, 72/177 (41%) attended no classes (38 of whom were also
in the booklet group), 29 (16%) attended less than half (18 of whom were also in the booklet group)
and 76 (43%) attended at least half (35 of whom were also in the booklet group).
Analysis of trial interventions
Disability at 12 months, as assessed by the ODI was not significantly better in patients receiving the
booklet (ODI mean difference 2.7, 95% C.I. -1.5 to 6.9) or those receiving rehabilitation (ODI mean
difference -2.7, 95% C.I. -6.8 to 1.5), however, there was a significant improvement from baseline in
all 4 groups (p<0.001), see Figure 2. Similarly, all secondary outcomes improved significantly from
baseline (p<0.001). However, apart from average leg pain and the difference between leg and back
pain, where rehabilitation lead to a significant reduction in severity (p<0.05), no effect of either
treatment intervention was evident, Table 3. There were no significant interactions (p<0.05)
between our two interventions (Table 3) indicating that it is reasonable to focus on the average
effects of the two treatments – booklet and rehabilitation.
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Table 3 ~ Analysis of trial interventions at 12 months
The longitudinal model looking at changes over time in the effect of treatment on ODI provided no
evidence of any interactions. An initial rapid reduction was observed in all four groups, (p<0.01),
following which the change in ODI appeared to plateaux in all groups, Figure 2. It is of interest to
note that at 6 weeks the booklet group appeared to have a lower rate of improvement than the
rehabilitation group, particularly since rehabilitation had not started at this stage. Similar non
significant patterns of change were seen with in leg and back pain, health status and depression.
Figure 2~ Change from baseline in ODI over time
Sub-group analysis
It was postulated that a number of baseline variables may influence the effectiveness of the trial
interventions. This was explored with a test for interaction using the following variables; surgery
type, baseline ODI, baseline BMI, HADS scores and the severity of back pain to leg pain. There was
weak evidence of interaction with surgical procedure (p=0.06 for both interventions). All other tests
for interaction were p>0.1.
Effect of surgery
We divided the population into the two respective surgery procedures used in the stratification ,
apart from age, the baseline characteristics of these patients were similar, see supplementary digital
content.
A further analysis was performed using a longitudinal mixed model with interactions of surgery type
with trial interventions, Figure 3. In the discectomy population, all participants improved
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dramatically regardless of treatment intervention. In the decompression population whilst all
subjects demonstrated a significant improvement, there was a suggestion that rehabilitation had a
positive influence on outcome and that perhaps the booklet had a negative influence, this was not
statistically significant. Of the other outcome measures, similar patterns of variability were observed
between the two populations particularly with respect to improvements in leg and back pain but
again these were not significant. It must be noted that this study was not designed or powered for
this analysis, and this finding would require confirmation through further research.
Fig 3 ~ ODI outcomes over time by surgical procedure
Discussion
This study sought to determine how patients having spinal surgery should be managed
postoperatively with a view to improving functional outcomes. To this effect it explored whether
outcome could be enhanced by either a post-operative rehabilitation programme or an evidencebased advice booklet or a combination of the two. The study targeted patients having either a
lumbar spine decompression or a disc herniation and was limited to those having primary surgery.
The study found no long term benefit of either intervention with respect to functional disability as
assessed using the ODI. The rehabilitation programme did have a significant impact on leg pain at
one year. However, when this improvement is examined more closely, it appears that the greatest
improvement occurs by the 6 week review prior to the instigation of rehabilitation, suggesting
simply knowing that you are getting rehabilitation can have an impact on recovery. Thus this study
does not lend support to the use of either intervention in the management of spinal surgery
patients.
However, planned sub-group analysis of the data raises the question of whether this
population should be considered as a whole or as two separate surgical procedures. Previous studies
into post-operative rehabilitation have tended to focus on the discectomy population in
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isolation24;26;27;43-45, with few studies addressing the decompression population28;46. In 2009, Ostelo et
al’s43 Cochrane review on rehabilitation following lumbar disc surgery22 concluded that there was
low quality evidence that rehabilitation could lead to a faster decrease in pain and disability,
subsequent studies supported this26;44. This is in contrast to the current study’s findings, particularly
the suggestion that patient having discectomy improved irrespective of post-operative intervention.
Interestingly most studies compared different types of exercise approaches rather than comparisons
with education, or no treatment despite suggestions that rehabilitation is the exception rather than
the norm13;47. One could argue that providing the booklet to the discectomy population achieves
modest gains at a low cost but this requires further investigation.
The picture for the decompression population disagrees with Mannion et al’s28 findings that
post-operative rehabilitation offers no improvement in functional or pain outcomes, but agrees with
Nielsen et al46 who found that pre and post-operative rehabilitation led to improvements in
function. In contrast to the disectomy population however, the booklet had only a short term
impact on outcome.
An important factor to note when considering postoperative rehabilitation is the range and
diversity of approaches from individual physiotherapy [Herbert et al 2010], to group sessions
encompassing self directed stretching and stabilisation exercises23, behavioural graded activities24;25,
neuromuscular training26, stabilisation classes and mixed therapies28, home educated and self
management interventions24;29, and strengthening regimes48. Indeed, Christiansen et al49 advocated
a “Back-café” concept in patients having spinal fusion surgery which comprised instructions to
exercise and group meetings with other patients and health-care practitioners to discuss progress
and problems. This approach has not been applied to other surgical approaches.
Variability also exists with respect to the timings of these interventions. Supported by
Carragee et al’s17 work some studies have instigated rehabilitation immediately following surgery50,
whilst other have opted for interventions 4-6 weeks following surgery51-53. This study instigated
rehabilitation at 6 weeks post-operatively at the request of the participating surgeons. However,
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immediate rehabilitation as advocated by Kjellby-Wendt et al 50 may have had a more marked
effect. Since most recovery occurs in the initial 3 months, perhaps greater surveillance of outcomes
during this time is also required. The poor compliance with rehabilitation was surprising, with 41%
patients attending none of the classes, perhaps reflecting timing and location. A trial of an exercise,
education and cognitive behavioural class for low back pain noted 27% did not attend any classes
with 63% attending half of the classes54. In this study 43% attended at least half of the classes.
Mannion et al28 noted higher levels of compliance; however, since many studies fail to report
compliance it is difficult to interpret our findings. This may change now that clearer guidance has
been provided on reporting RCTs of non-pharmacologic treatments55.
The concept of giving patients advice and information is not new56, and increasingly
providing information is deemed to be a crucial aspect of current medical practice that can improve
patient’s expectations of treatments and thus enhance satisfaction57;58. A common complaint from
patients has been the difficulty in finding sufficient reliable information56, which is hampered by the
underestimation of many healthcare professionals regarding the patient’s desire and ability to cope
with information59. “Your back operation” 31 was developed to address this and initial patient
evaluations were positive32. However, the results of this trial are mixed. When considering the two
populations as a whole, there is a suggestion that the booklet may be having an initial positive
impact, which is not maintained; but there is a divergence in the findings between surgical
procedures, with information alone appearing sufficient for discectomy patients.
It is the decompression population that is of interest, as here the trends suggest that not
only is the initial positive impact of the booklet not maintained, but that recovery rates appear to be
less pronounced from 3 months onwards. Williamson et al’s47 survey suggests that patients lack
confidence to do exercise without supervision, but this observation applies to both surgical groups.
Perhaps the age of the patient and the duration of the pre-operative symptoms contribute to this
finding. It is recognised that in stenosis, patients also have marked back pain which could prevent
them using the advice given by the booklet however the data does not support this. In the design of
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the trial, to avoid contamination between groups, patients were given the booklet on discharge
rather than on admission; this may have influenced the findings as certainly a large component of
the booklet addressed the surgery and the operative stay.
An interesting finding of this study which builds on other recent papers28;60;61, is the rapid
improvement in symptoms in the initial 3 month post-operative period which is followed by a clear
plateaux in both populations for the majority of outcomes. The study achieved a comparatively high
rate of one year returns (86%), as did that of Mannion et al62 (95%) and as such minimises the risk of
this being a chance finding. This questions the need for follow up periods of longer than one year
following this type of surgery. This is important information for clinicians to convey to patient
undergoing and recovering from surgery and should be included in education material.
To summarise, this trial has produced some interesting and unexpected observations many
of which are counter intuitive. Practical and clinician led requests also influenced the trial design
such that rehabilitation was delivered perhaps too late for these patients and the information was
received too late in an attempt to minimise cross-over between groups. Traditionally outcome is
reviewed at 3, 6 and 12 months and perhaps in future these should include earlier time points to
capture the full impact of interventions. Clearly the provision of education for patients requires
greater consideration and should be patient rather than clinician led, focussing on what patients
need to know rather than what we feel confident telling them. It has also become apparent that
type of surgery may impact on type of post-operative rehabilitation and this requires further
exploration. Consequently this study can find no support for the provision of post-operative
rehabilitation or educational interventions.
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