Physiotherapist-Directed Exercise, Advice, or Both for Subacute Low Back Pain

A Randomized Trial

  1. Liset H.M. Pengel, PhD;
  2. Kathryn M. Refshauge, PhD;
  3. Christopher G. Maher, PhD;
  4. Michael K. Nicholas, PhD;
  5. Robert D. Herbert, PhD; and
  6. Peter McNair, PhD
  1. From the Royal College of Surgeons of England, London, United Kingdom; University of Sydney, Sydney, Australia; Royal North Shore Hospital, St. Leonards, Australia; and Auckland University of Technology, Auckland, New Zealand.

    Abstract

    Background: Advice and exercise are widely recommended for subacute low back pain, but the effectiveness of these interventions is unclear.

    Objective: To investigate the effectiveness of physiotherapist-prescribed exercise, advice, or both for subacute low back pain.

    Design: Factorial randomized, placebo-controlled trial.

    Setting: 7 university hospitals and primary care clinics in Australia and New Zealand.

    Patients: 259 persons with subacute low back pain (>6 weeks and <3 months in duration).

    Intervention: Participants received 12 physiotherapist-directed exercise or sham exercise sessions and 3 physiotherapist-directed advice or sham advice sessions over 6 weeks.

    Measurements: Primary outcomes were average pain over the past week (scale, 0 to 10), function (Patient-Specific Functional Scale), and global perceived effect (11-point scale) at 6 weeks and 12 months. Secondary outcomes were disability (Roland–Morris Disability Questionnaire), number of health care contacts, and depression (Depression Anxiety Stress Scales-21).

    Results: Exercise and advice were each slightly more effective than placebo at 6 weeks but not at 12 months. The effect of advice on the pain scale was −0.7 point (95% CI, −1.2 to −0.2 point; P = 0.011) at 6 weeks and −0.4 point (CI, −1.0 to 0.3 point; P = 0.27) at 12 months, whereras the effect of exercise was −0.8 point (CI, −1.3 to −0.3 point; P = 0.004) at 6 weeks and −0.5 point (CI, −1.1 to 0.2 point; P = 0.14) at 12 months. The effect of advice on the function scale was 0.7 point (CI, 0.1 to 1.3 points; P = 0.014) at 6 weeks and 0.6 point (CI, 0.1 to 1.2 points; P = 0.023) at 12 months, and the effect of exercise was 0.4 point (CI, −0.2 to 1.0 point; P = 0.174) at 6 weeks and 0.5 point (CI, −0.1 to 1.0 point; P = 0.094) at 12 months. The effect of advice on the global perceived effect scale was 0.8 point (CI, 0.3 to 1.2 points; P < 0.001) at 6 weeks and 0.3 point (CI, −0.2 to 0.9 point; P = 0.24) at 12 months, and the effect of exercise was 0.5 point (CI, 0.1 to 1.0 point; P = 0.017) at 6 weeks and 0.4 point (CI, −0.1 to 1.0 point; P = 0.134) at 12 months. When administered together, exercise and advice had larger effects on all outcomes at 6 weeks (effect on pain, −1.5 [CI −2.2 to −0.7 point; P = 0.001], with similar results for other primary outcomes); however, by 12 months, there was a statistically significant effect only for function (effect, 1.1 points [CI, 0.3 to 1.8 points]; P = 0.005).

    Limitation: Physiotherapists were not blinded.

    Conclusions: In participants with subacute low back pain, physiotherapist-directed exercise and advice were each slightly more effective than placebo at 6 weeks. The effect was greatest when the interventions were combined. At 12 months, the only effect that persisted was a small effect on participant-reported function.

    Australian Clinical Trials Registry registration number: 12605000039684.

    Article and Author Information

    • Acknowledgments: The authors thank the staff at the physiotherapy departments at Bankstown Hospital, Concord Repatriation General Hospital, Royal Prince Alfred Hospital, Royal North Shore Hospital, and St. George Hospital, Sydney, Australia; New Lambton Physiotherapy Centre, Newcastle, Australia; and Middlemore Hospital, Auckland, New Zealand. They also thank Ms. Lois Tonkin and Ms. Judy Chen for their advice on treatment and Dr. Tim Dobbins for conducting the statistical analyses.

    • Grant Support: In part by a National Health and Medical Research Council of Australia Project grant (no. 107203) and the Australasian Low Back Pain Trial Committee. The Australasian Low Back Pain Trial Committee comprises Musculoskeletal Physiotherapy Australia, Physiotherapy Business Australia, and the New Zealand Manipulative Physiotherapists Association. Drs. Maher and Herbert hold research fellowships funded by the National Health and Medical Research Council of Australia.

    • Potential Financial Conflicts of Interest: None disclosed.

    • Requests for Single Reprints: Christopher G. Maher, PhD, Discipline of Physiotherapy, Faculty of Health Sciences, University of Sydney, PO Box 170, Lidcombe, New South Wales 1825, Australia; e-mail, c.maher{at}usyd.edu.au.

    • Current Author Addresses: Dr. Pengel: Centre for Evidence in Transplantation, Royal College of Surgeons of England, 35-43 Lincoln's Inn Fields, London WC2A 3PE, United Kingdom.

    • Drs. Refshauge, Maher, and Herbert: Discipline of Physiotherapy, Faculty of Health Sciences, University of Sydney, PO Box 170, Lidcombe, New South Wales 1825, Australia.

    • Dr. Nicholas: Pain Management and Research Institute E25, University of Sydney, Royal North Shore Hospital, St. Leonards, New South Wales 2065, Australia.

    • Dr. McNair: School of Physiotherapy, Auckland University of Technology, Private Bag 92006, Auckland 1020, New Zealand.

    • Author Contributions: Conception and design: K.M. Refshauge, C.G. Maher, M.K. Nicholas, P. McNair.

    • Analysis and interpretation of the data: L.H.M. Pengel, K.M. Refshauge, C.G. Maher, R.D. Herbert.

    • Drafting of the article: L.H.M. Pengel, K.M. Refshauge, C.G. Maher, M.K. Nicholas, R.D. Herbert.

    • Critical revision of the article for important intellectual content: L.H.M. Pengel, K.M. Refshauge, C.G. Maher, M.K. Nicholas, R.D. Herbert, P. McNair.

    • Final approval of the article: L.H.M. Pengel, K.M. Refshauge, C.G. Maher, M.K. Nicholas, R.D. Herbert, P. McNair.

    • Provision of study materials or patients: M.K. Nicholas.

    • Statistical expertise: R.D. Herbert.

    • Obtaining of funding: K.M. Refshauge, C.G. Maher, M.K. Nicholas, P. McNair.

    • Administrative, technical, or logistic support: L.H.M. Pengel, M.K. Nicholas.

    • Collection and assembly of data: L.H.M. Pengel, K.M. Refshauge, C.G. Maher, P. McNair.

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