CMTBC Education Day
April 13, 2014
Donelda Gowan-Moody, MT, MSc, PhD student
Department of Community Health & Epidemiology
University of Saskatchewan
Key
Messages
2
1)
There are gaps
in what we
know about
the ‘adverse’
2)
Clarity and
consensus is
needed

what we do know about adverse events (AEs)
in MT

what relevant research others have done

what we need to do – explore views
3

Patient safety is an important domain of
population health and a Canadian national
priority (Baker, 2004) - do no harm

Few data on professions that use manual
therapies – physiotherapy, osteopathy, MT

Few data on manual therapies –massage,
mobilization and manipulation, acupuncture
4

WHO International Classification for Patient
Safety – key concepts, conceptual
framework, consensus

JCAHO Patient Safety Event Taxonomy –
impact, type, domain, cause, prevention

Common Terminology Criteria for Adverse
Events (v4.02) National Cancer Institute
5

Adverse reaction: an unintended noxious
response under normal dosage.

Adverse event/adverse experience: Any
untoward medical occurrence ;does not
necessarily have a causal relationship

Side effect: Any unintended effect related to
the pharmacological properties of the drug.
6

Adverse event: An event that results in
unintended harm to the patient, and is
related to the care and/or services provided
to the patient rather than to the patient’s
underlying medical condition (Canadian Patient
Safety Institute)

Harm: An outcome that negatively affects the
patient’s health and/or quality of life (CPSI)
7
Posadzki P, Ernst E. The safety of massage
therapy: an update of a systematic review.
Focus on Alternative and Complementary
Therapies. 2013;18(1):27-32
17 case reports and 1 case series
Updates Ernst (2003) - 16 case reports and 4
case series
8
Chen et al. Small bowel intramural hematoma
secondary to abdominal massage. Am J Emerg Med.
2013 Apr;31(4):758 e3-4. PubMed PMID: 23380131.
Jabr FI. Massive Pulmonary Emboli after Legs
Massage. Am J Phys Med Rehabil. 2007; 86(8): 691.
Chakrapani et al. Bilateral Carotid and Bilateral
Vertebral Artery Dissection Following Facial
Massage. Angiology. 2009;59(6):761-4.
9

Lee et al. Cervical cord injury after massage.
Am J Phys Med Rehabil. 2011;90(10):856-9.

Guo et al. Isolated unilateral vertebral pedicle
fracture caused by a back massage in an
elderly patient: a case report and literature
review Eur J Orthop Surg Traumatol
[Internet]. 2012.
10

Aksoy et al. Spinal accessory neuropathy
associated with deep tissue massage: a case
report. Archives of physical medicine and
rehabilitation. 2009;90(11):1969-72.
11
Grant KE. Massage safety: injuries reported in
Medline relating to the practice of
therapeutic massage-1965-2003. J Bodyw
Mov Ther. 2003;7(4):207-12
12

Average annual rate of claims per 1000
insured = 1.8 claims per 1000 massage
therapists from 1993-1996
Studdert D, Eisenberg D, Miller F, Curto D,
Kaptchuk T, Brennan T. Medical malpractice
implications of alternative medicine/. The
Journal of the American Medical Association.
1998;280:1610-5.
13
Cambron JA, Dexheimer J, Coe P, Swenson R.
Side-Effects of Massage Therapy: A CrossSectional Study of 100 Clients. J Altern
Complement Med. 2007;13(8):793-96
14

International Journal of Therapeutic Massage
and Bodywork: Research, Education, and
Practice
http://www.ijtmb.org/index.php/ijtmb

Peer-reviewed, indexed in PubMed,
Subscription-free open-access, Electronic
15
Number of articles by title search of
common terms in IJTMB 2008 - 2014
45
40
35
30
25
20
15
10
5
0
TMB
Bodywork* Therapeutic Massage
Massage
Massage
Ther*
16
Number of articles by title search of types of
TMBs in IJTMB 2008 - 2014
45
40
35
30
25
20
15
10
5
0
Massage Therapy Myofascial Release
Other
17

Patient safety in community-based
healthcare: Understanding adverse events in
massage therapy

Purpose: to develop a clear definition of
adverse events (AEs) in massage therapy to
facilitate understanding of patient safety
issues and aid recording and prevention of
AEs in MT
18

This project was approved on ethical grounds
by the University of Saskatchewan
Behavioural Research Ethics Board.

Your participation is voluntary and you can
answer only those questions that you are
comfortable with. You may withdraw from
participation for any reason, at any time
without explanation or penalty of any sort.
19




What are the gaps?
Does the evidence presented link in any way
to practice?
What are the concepts for which we should
seek clarity?
Other insights?
20

How do patients receiving manual therapy
through Ontario chiropractic, physiotherapy
or osteopathic care define and interpret AEs
associated with manual therapy techniques?

Manual tx = joint manipulation or
mobilization NOT soft tissue

Carlesso et al, 2011
21

Functional impact

Changes in symptom location or quality

Neurologic-type symptoms
22

Patients with LBP will identify adverse
responses 51% more

Patients with an expectation of
posttreatment soreness are 9% less likely to
identify an adverse response

Being advised about potential; or getting
better overall are important
23
Carlesso LC, Gross AR, Santaguida PL, Burnie S,
Voth S, Sadi J. Adverse events associated
with the use of cervical manipulation and
mobilization for the treatment of neck pain in
adults: a systematic review. Manual Therapy.
2010 Oct;15(5):434-44
24
Johnson et al (2012) demonstrated that
"massage" as a physical therapy modality was
in the top 5 treatments causing injury.
Exercise
Spinal manipulation or joint mobilization
Taping
Heat
Massage and acupuncture
25
Carnes et al,2010 Adverse events and manual
therapy: a systematic review.
 Manual therapy: any techniques
administered manually, using touch, by a
trained practitioner for therapeutic purposes
 Advice, through soft tissue massage and
passive or active mobilisation, to
manipulation
 Statutory registered/ regulated professional
26
Meta-analysis of RCTs major AE: 0.13% (0/2301 txs)
Minor or moderate: 22% (11.1-36.2)
From the cohort studies –
Major AE: 0.007% (0/42 451)
Minor or moderate: 41% 95% CI (17-68%)
27
Constructs measured on a 6 point rating scale:
For example:
 Level of distress
 Treatment alterations required or no
 Expected or Unexpected
 Acceptable or Unacceptable
28

Study aim: to investigate how osteopathic
patients view post-treatment experiences
and what meaning they ascribe to them

Conducted focus groups with patients from a
teaching clinic
29

Perceptions evolve; clinical change is
evaluated within the context of their ‘global
osteopathic experience’

Non-clinical factors, such as feeling
respected, understanding through education
and service efficiency

Clinical factors – function and quality of life
30
Masunaga Shiatsu: a Japanese body-based lifeenergy therapy.
Zen or Masunaga: a theoretical framework
Holistic, mind-body approach
Transition effects: healing crisis
31
Type 1 – unrelated
Type 2 – Transitional – client describes
experience as initially (-) then (+)
Type 3 – Transitional- consistent with modality
theory (example feeling exhausted)
Type 4 – Undesired event or effect but no risk
to safety; distressing and interferes
Type 5 - Potentially adverse events or effects –
may represent a risk to client safety
32

Is there anything useful here from what
others have done?

Is MT in any way unique?
33

What puts the adverse in 'adverse events'?

What are the potential negative consequences of
massage therapy treatment?

What is the common terminology used in describing
negative experiences in massage therapy?

What elements would be necessary in a
classification system for adverse events?
34

What are the important constructs for
providing meaning for adverse events?

What are the important descriptors for
categories of adverse events?
35
•
scarce data, inconsistent aims, and disparate
conceptualizations of adverse events
•
there are disparate conceptualizations of
manual therapy and massage therapy.
•
There remains a gap in the understanding of
patient safety in massage therapy.
36
1) To describe and define the attributes of the
concept of AEs in MT as compared to other
manual therapies and medicine
2) To develop a conceptual taxonomic
framework
3) To develop and pilot a data collection tool to
be used in gathering, evaluating and
reporting AEs in MT.
37
I gratefully acknowledge the Department of
Community Health & Epidemiology for
scholarship support.
The CMTBC and MTABC for their ongoing
support of this work.
38
Baker G. R., Norton P. G., Flintoft V., Blais, R., Brown, A., Cox, J., Etchells, E., Ghali, W. A.,
Hébert, P., Majumdar, S. R., O’Beirne, M., Palacios-Derflingher, L., Reid, R. J., Sheps, S. &
Tamblyn, R. (2004). The Canadian Adverse Events Study: the incidence of adverse events
among hospital patients in Canada. Canadian Medical Association Journal, 170, 1678-1686
World Health Organization (2009). Final Technical Report for the Conceptual Framework for the
International Classification for Patient Safety v.11. Geneva, Switzerland: Author. Retrieved
from http://www.who.int/patientsafety/taxonomy/icps_full_report.pdf
Andrew Chang et al. “The JCAHO patient safety event taxonomy: a standardized terminology
and classification schema for near misses and adverse events.” International Journal for
Quality in Health Care17, no. 2 (2005): 95-105
Ernst E. The safety of massage therapy. Rheumatology. 2003;42:1101-6
Posadzki P, Ernst E. The safety of massage therapy: an update of a systematic review. Focus on
Alternative and Complementary Therapies. 2013;18(1):27-32
Grant KE. Massage safety: injuries reported in Medline relating to the practice of therapeutic
massage-1965-2003. J Bodyw Mov Ther. 2003;7(4):207-12
39
Runciman W, Hibbert P, Thomson R, Van Der Schaaf T, Sherman H, Lewalle P.
Towards an International Classification for Patient Safety: key concepts and
terms. International Journal for Quality in Health Care. 2009 February 1,
2009;21(1):18-26.
Carlesso LC, Cairney J, Dolovich L, Hoogenes J. Defining adverse events in manual
therapy: an exploratory qualitative analysis of the patient perspective. Man Ther.
2011 Oct;16(5):440-6.
Johnson GM, Skinner MA, Stephen RE. Lessons to be learned: a retrospective
analysis of physiotherapy injury claims. Journal of Orthopaedic & Sports Physical
Therapy. 2012;42(8):698-704. PubMed PMID: 22711215.
Carlesso LC, MacDermid JC, Santaguida PL, Thabane L. A survey of patient's
perceptions of what is "adverse" in manual physiotherapy and predicting who is
likely to say so. J Clin Epidemiol. 2013 Oct;66(10):1184-91
40
Carnes D, Mars TS, Mullinger B, Froud R, Underwood M. Adverse events and manual
therapy: a systematic review. Man Ther. 2010 Aug;15(4):355-63
Carnes D, Mullinger B, Underwood M. Defining adverse events in manual therapies:
a modified Delphi consensus study. Man Ther. 2010 Feb;15(1):2-6
Rajendran D, Bright P, Bettles S, Carnes D, Mullinger B. What puts the adverse in
'adverse events'? Patients' perceptions of post-treatment experiences in
osteopathy--a qualitative study using focus groups. Man Ther. 2012
Aug;17(4):305-11
Long AF, Esmonde L, Connolly S. A typology of negative responses: A case study of
shiatsu. Complementary therapies in medicine. 2009 6//;17(3):168-75.
41
Key
Messages
42
1)
There are gaps
in what we
know
2)
Clarity and
consensus is
needed
43