ArticlesComprehensive physiotherapy exercise programme or advice for chronic whiplash (PROMISE): a pragmatic randomised controlled trial
Introduction
Whiplash-associated disorders are a large public health problem and are associated with substantial social and economic costs.1 Findings of systematic reviews of the prognosis of the disorders show that more than half of individuals will continue to report symptoms 6 months after injury,2 with up to 30% having moderate to severe pain and disability.1 This group of people with chronic symptoms accounts for a disproportionately large percentage of the burden associated with whiplash-associated disorders because of continuing treatment costs and loss of productivity.3
Various treatments have been proposed to manage these chronic disorders; however, up to now very few randomised controlled trials have been done to assess the effectiveness of these interventions.4 Findings of one of the few high quality randomised controlled trials5 in this specialty have shown that radiofrequency neurotomy is effective in patients whose pain arose from zygapophyseal joints. However, neurotomies are highly technical procedures, might not provide permanent symptom relief, and even when patients are carefully selected, are effective only in some.5 Subsequently, clinical practice guidelines recommend the use of conservative treatment approaches such as physiotherapy exercise programmes for chronic whiplash-associated disorders despite the absence of robust evidence supporting this approach.6 Two trials7, 8 provided some evidence for the effectiveness of physiotherapy exercise programmes; however, the effects of treatments were modest; only 10–20% of patients had a successful outcome, defined as minimum to no pain and disability. On the basis of these findings, our group postulated that a comprehensive exercise programme combining aspects of both specific motor relearning and graded activity might result in greater improvements in pain and disability compared with an exercise programme alone.9
Evidence from studies of acute whiplash-associated disorders suggests that extended physiotherapy programmes provide no additional benefit compared with brief physiotherapy interventions. The UK MINT trial10 showed that six sessions of physiotherapy during 8 weeks provided short-term but not long-term benefits compared with one advice session, and that the comprehensive package of physiotherapy was not cost effective from the UK National Health Service (NHS) perspective. However, whether the MINT results apply to chronic whiplash-associated disorders is unclear. Therefore, we aimed to investigate the effectiveness of a comprehensive exercise programme delivered by physiotherapists compared with one advice session and telephone support for people with a chronic whiplash-associated disorder. We also investigated whether features suggestive of CNS hyperexcitability or psychological distress changed the effect of treatment.
Section snippets
Study design and participants
PROMISE is a two-group, pragmatic randomised controlled trial in which participants were recruited from sites in Sydney and Brisbane, Australia, between Sept 21, 2009, and Feb 27, 2012, with follow-up at 14 weeks, 6 months, and 12 months. Ethics approval was obtained from the University of Sydney (03–2009/11509) and the University of Queensland human research ethics committees (2008002059). All participants gave written informed consent before study entry. The study protocol has been previously
Results
Recruitment ran between Sept 21, 2009, and Feb 27, 2012, with follow-up completed on Feb 27, 2013. The figure shows the reasons for ineligibility and the flow of participants through the trial. Of the participants who were randomly assigned, 157 participants (91%) were followed up at 14 weeks, 145 (84%) at 6 months, and 150 (87%) at 12 months. Two participants (one from each group) were later excluded when additional information about their health status emerged after randomisation. One
Discussion
An intensive 12 week comprehensive exercise programme delivered by physiotherapists for people with chronic whiplash-associated disorders did not provide additional benefit over advice for the primary outcome of average pain intensity in the preceding week. We noted a significant, although clinically unimportant, benefit for two of the secondary outcome measures (self-reported recovery and functional ability). We did not find any evidence to support the hypothesis that differential responses to
References (39)
- et al.
Course and prognostic factors of whiplash: a systematic review and meta-analysis
Pain
(2008) - et al.
Randomized controlled trial of exercise for chronic whiplash-associated disorders
Pain
(2007) - et al.
Does the presence of sensory hypersensitivity influence outcomes of physical rehabilitation for chronic whiplash?--A preliminary RCT
Pain
(2007) - et al.
Emergency department treatments and physiotherapy for acute whiplash: a pragmatic, two-step, randomised controlled trial
Lancet
(2013) - et al.
Reproducibility and responsiveness of the Whiplash Disability Questionnaire
Pain
(2004) - et al.
Reliability and concurrent validity of two instruments for measuring cervical range of motion: effects of age and gender
Man Ther
(1995) - et al.
The S-LANSS score for identifying pain of predominantly neuropathic origin: validation for use in clinical and postal research
J Pain
(2005) - et al.
An investigation of the use of a numeric pain rating scale with ice application to the neck to determine cold hyperalgesia
Man Ther
(2013) - et al.
Management of acute whiplash: a randomized controlled trial of multidisciplinary stratified treatments
Pain
(2013) - et al.
Disability-adjusted life-years (DALYs) for 291 diseases and injuries in 21 regions, 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010
Lancet
(2012)
The effects of intra-oral pain on motor cortex neuroplasticity associated with short-term novel tongue-protrusion training in humans
Pain
Toward lessening the rate of transition of acute whiplash to a chronic disorder
Spine
The economic impact of motor vehicle crashes, 2000
Conservative treatments for whiplash. [Systematic Review]
Cochrane Database Syst Rev
Percutaneous radio-frequency neurotomy for chronic cervical zygapophyseal-joint pain
N Engl J Med
Clinical guidelines for the best practice management of acute and chronic whiplash-associated disorders
A randomised clinical trial of a comprehensive exercise program for chronic whiplash: trial protocol
BMC Musculoskelet Disord
The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection
Med Care
ACSM's guidelines for exercise testing and prescription
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