PREVENT TRIAL: A RANDOMISED, PLACEBO CONTROLLED TRIAL OF ADVICE FOR ACUTE LOW BACK PAIN

Traeger A.C.1, Huebscher M.1, Lee H.1, Skinner I.W.1, Moseley G.L.1,2, McAuley J.H.1
1NeuRA, University of New South Wales, Sydney, Australia, 2Sansom Institute for Health Research, University of South Australia, Adelaide, Australia

Background: Low back pain causes more disability worldwide than any other health condition. Clinical guidelines suggest advice and reassurance for initial management, but good quality evidence for these treatments is lacking. This randomised trial evaluated the effect of physiotherapists providing advice based on 'Explain Pain' to patients with acute low back pain.

Purpose: To determine whether two, 1-hour sessions of advice based on Explain Pain was more effective than two, 1-hour sessions of placebo advice.

Methods: We recruited participants from primary care (physiotherapy, general practice) centres in Sydney, Australia. To be eligible, participants had to have acute, non-specific low back pain of less than 4 weeks’ duration, be 18-75 years old, and be screened as being at high-risk of poor prognosis. We defined ‘high-risk’ as having >30% risk of developing chronic low back pain according to a validated prognostic model (PICKUP). For the advice intervention, one of two physiotherapists provided the sessions. Each session involved discussion of pain biology concepts, namely that nociception and pain are different, and that the brain always determines how much pain one feels. For the placebo intervention, the physiotherapist gathered information and used active listening techniques, but did not provide any advice. The primary outcome was pain intensity (Numeric Rating Scale) over the past week, which we collected at one, 12, 24 and 52 weeks via online questionnaires. Secondary outcomes included the incidence of chronic low back pain, disability, pain intensity, depression, healthcare utilisation, pain attitudes and beliefs, global recovery and recurrence.

Results: We randomised 202 participants to the Explain Pain (n=101) or placebo advice (n=101) sessions. Follow-up rates exceeded 95% at one, 12, and 24 weeks. 52 week follow-up data are due in December 2016. We will present between group differences for the first time at the conference.

Conclusion(s): This trial will provide data on the first placebo-controlled trial of advice for patients with acute low back pain.

Implications: Results will have implications for the widespread recommendation to provide patients with advice and reassurance.

Funding acknowledgements: This work is supported by an Australian National Health and Medical Research Council grant, number APP1047827.

Topic: Musculoskeletal: spine

Ethics approval: Ethical approval was obtained from the University of New South Wales Human Ethics Committee in June 2013 (ref number HC12664).


All authors, affiliations and abstracts have been published as submitted.

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