Elsevier

The Lancet

Volume 384, Issue 9938, 12–18 July 2014, Pages 133-141
The Lancet

Articles
Comprehensive physiotherapy exercise programme or advice for chronic whiplash (PROMISE): a pragmatic randomised controlled trial

https://doi.org/10.1016/S0140-6736(14)60457-8Get rights and content

Summary

Background

Evidence suggests that brief physiotherapy programmes are as effective for acute whiplash-associated disorders as more comprehensive programmes; however, whether this also holds true for chronic whiplash-associated disorders is unknown. We aimed to estimate the effectiveness of a comprehensive exercise programme delivered by physiotherapists compared with advice in people with a chronic whiplash-associated disorder.

Methods

PROMISE is a two group, pragmatic randomised controlled trial in patients with chronic (>3 months and <5 years) grade 1 or 2 whiplash-associated disorder. Participants were randomly assigned by a computer-generated randomisation schedule to receive either the comprehensive exercise programme (20 sessions) or advice (one session and telephone support). Sealed opaque envelopes were used to conceal allocation. The primary outcome was pain intensity measured on a 0–10 scale. Outcomes were measured at baseline, 14 weeks, 6 months, and 12 months by a masked assessor. Analysis was by intention to treat, and treatment effects were calculated with linear mixed models. The trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12609000825257.

Findings

172 participants were allocated to either the comprehensive exercise programme (n=86) or advice group (n=86); 157 (91%) were followed up at 14 weeks, 145 (84%) at 6 months, and 150 (87%) at 12 months. A comprehensive exercise programme was not more effective than advice alone for pain reduction in the participants. At 14 weeks the treatment effect on a 0–10 pain scale was 0·0 (95% CI −0·7 to 0·7), at 6 months 0·2 (−0·5 to 1·0), and at 12 months −0·1 (−0·8 to 0·6). CNS hyperexcitability and symptoms of post-traumatic stress did not modify the effect of treatment. We recorded no serious adverse events.

Interpretation

We have shown that simple advice is equally as effective as a more intense and comprehensive physiotherapy exercise programme. The need to identify effective and affordable strategies to prevent and treat acute through to chronic whiplash associated disorders is an important health priority. Future avenues of research might include improving understanding of the mechanisms responsible for persistent pain and disability, investigating the effectiveness and timing of drugs, and study of content and delivery of education and advice.

Funding

The National Health and Medical Research Council of Australia, Motor Accidents Authority of New South Wales, and Motor Accident Insurance Commission of Queensland.

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

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