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Research

Efficacy of standardised manual therapy and home exercise programme for chronic rotator cuff disease: randomised placebo controlled trial

BMJ 2010; 340 doi: https://doi.org/10.1136/bmj.c2756 (Published 08 June 2010) Cite this as: BMJ 2010;340:c2756
  1. Kim Bennell, professor1,
  2. Elin Wee, physiotherapist and research assistant1,
  3. Sally Coburn, physiotherapist12,
  4. Sally Green, professor3,
  5. Anthony Harris, professor4,
  6. Margaret Staples, biostatistician56,
  7. Andrew Forbes, professor6,
  8. Rachelle Buchbinder, professor56
  1. 1Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, University of Melbourne, Parkville 3010, Victoria, Australia
  2. 2Department of Physiotherapy, Royal Melbourne Hospital, Melbourne
  3. 3Monash Institute of Health Services Research, Monash University, Melbourne
  4. 4Centre for Health Economics, Monash University
  5. 5Monash Department of Clinical Epidemiology, Cabrini Hospital, Melbourne
  6. 6Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University
  1. Correspondence to: K Bennell k.bennell{at}unimelb.edu.au
  • Accepted 25 March 2010

Abstract

Objective To investigate the efficacy of a programme of manual therapy and exercise treatment compared with placebo treatment delivered by physiotherapists for people with chronic rotator cuff disease.

Design Randomised, participant and single assessor blinded, placebo controlled trial.

Setting Metropolitan region of Melbourne, Victoria, Australia.

Participants 120 participants with chronic (>3 months) rotator cuff disease recruited through medical practitioners and from the community.

Interventions The active treatment comprised a manual therapy and home exercise programme; the placebo treatment comprised inactive ultrasound therapy and application of an inert gel. Participants in both groups received 10 sessions of individual standardised treatment over 10 weeks. For the following 12 weeks, the active group continued the home exercise programme and the placebo group received no treatment.

Main outcome measures The primary outcomes were pain and function measured by the shoulder pain and disability index, average pain on movement measured on an 11 point numerical rating scale, and participants’ perceived global rating of overall change.

Results 112 (93%) participants completed the 22 week trial. At 11 weeks no difference was found between groups for change in shoulder pain and disability index (3.6, 95% confidence interval −2.1 to 9.4) or change in pain (0.7, −0.1 to 1.5); both groups showed significant improvements. More participants in the active group reported a successful outcome (defined as “much better”), although the difference was not statistically significant: 42% (24/57) of active participants and 30% (18/61) of placebo participants (relative risk 1.43, 0.87 to 2.34). The active group showed a significantly greater improvement in shoulder pain and disability index than did the placebo group at 22 weeks (between group difference 7.1, 0.3 to 13.9), although no significant difference existed between groups for change in pain (0.9, −0.03 to 1.7) or for the percentage of participants reporting a successful treatment outcome (relative risk 1.39, 0.94 to 2.03). Several secondary outcomes favoured the active group, including shoulder pain and disability index function score, muscle strength, interference with activity, and quality of life.

Conclusion A standardised programme of manual therapy and home exercise did not confer additional immediate benefits for pain and function compared with a realistic placebo treatment that controlled for therapists’ contact in middle aged to older adults with chronic rotator cuff disease. However, greater improvements were apparent at follow-up, particularly in shoulder function and strength, suggesting that benefits with active treatment take longer to manifest.

Trial registration Clinical trials NCT00415441.

Footnotes

  • We acknowledge the support and contribution of the Physiotherapy Department of the Royal Melbourne Hospital, particularly Geraldine Millard and Lauren Andrew, as well as the project physiotherapists Richard Bohen, Tanja Farmer, Marie-Louise Francken, Nigel Friend, Jean Leaf, Arthur Lee, Stephen Maloney, Christine Roberts, Paul Visentini, Jennifer Maciel, Richard Burton, Jane Burman, Debbie Virtue, and Simon Wilson. Ben Metcalf also assisted with data analysis and preparation of the manuscript.

  • Contributors: KB, SC, and RB conceived and designed the trial protocol. KB, RB, SG, SC, AH, and AF procured the project funding. SC and SG designed the physiotherapy intervention. AF designed and coordinated the statistical analysis and generated the randomisation table. MS did the analyses. EW was the project manager and blinded assessor. KB drafted the manuscript, and RB, EW, SC, SG, AH, MS, and AF contributed to the manuscript. All authors read and approved the final manuscript. KB is the guarantor.

  • Funding: KB is funded in part by an Australian Research Council future fellowship. RB is funded in part by an Australian National Health and Medical Research Council practitioner fellowship. This work was funded by the National Health and Medical Research Council (project grant #299840). Pilot funds were provided by ANZ Trustees, Department of Physiotherapy and Victor Hurley Grant Royal Melbourne Hospital and the School of Physiotherapy, University of Melbourne. The study sponsors had no role in the design; in the collection, analysis, and interpretation of the data; or in the writing of the article and the decision to submit it for publication.

  • Competing interests: All authors have completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare (1) RB and KB are partly supported by fellowships from the National Health and Medical Research Council and the Australian Research Council respectively. None of the other authors have financial support for the submitted work from anyone other than their employer; (2) No financial relationships with commercial entities that might have an interest in the submitted work; (3) No spouses, partners, or children with relationships with commercial entities that might have an interest in the submitted work; (4) No non-financial interests that may be relevant to the submitted work.

  • Ethical approval: The Royal Melbourne Hospital Human Research Ethics Committee approved the study (project #2001.115), and all participants gave written informed consent.

  • Data sharing: Physiotherapy protocols, technical appendix, statistical code, and dataset are available from the corresponding author at k.bennell{at}unimelb.edu.au.

This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.

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