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  • Clinical and cost-effectiveness of progressive exercise compared with best practice advice, with or without corticosteroid injection, for the treatment of rotator cuff disorders: protocol for a 2x2 factorial randomised controlled trial (the GRASP trial)

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Rehabilitation medicine
Protocol
Clinical and cost-effectiveness of progressive exercise compared with best practice advice, with or without corticosteroid injection, for the treatment of rotator cuff disorders: protocol for a 2x2 factorial randomised controlled trial (the GRASP trial)
  1. Sally Hopewell1,
  2. David J Keene1,
  3. Michael Maia Schlüssel1,
  4. Melina Dritsaki1,
  5. Susan Dutton1,
  6. Andrew Carr1,
  7. William Hamilton2,
  8. Zara Hansen1,
  9. Anju Jaggi3,
  10. Chris Littlewood4,
  11. Hessam Soutakbar1,
  12. Peter Heine1,
  13. Lucy Cureton1,
  14. Karen Barker5,
  15. Sarah E Lamb1
  1. 1 Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
  2. 2 Medical School, University of Exeter, Exeter, UK
  3. 3 Royal National Orthopaedic Hospital NHS Trust, Stanmore, Middlesex, UK
  4. 4 Primary Care and Health Sciences, Keele University, Keele, UK
  5. 5 Oxford University Hospitals NHS Trust, Oxford, UK
  1. Correspondence to Dr. Sally Hopewell; sally.hopewell{at}csm.ox.ac.uk

Abstract

Introduction Shoulder pain is very common, with around 70% of cases due to disorders of the rotator cuff. Despite widespread provision of physiotherapy, there is uncertainty about which type of exercise and delivery mechanisms are associated with best outcomes. There is also uncertainty around the long-term benefits and harms of corticosteroid injection therapy, which is often used in addition to physiotherapy. The Getting it Right: Addressing Shoulder Pain trial will assess the clinical and cost-effectiveness of individually tailored, progressive exercise compared with best practice advice, with or without corticosteroid injection, in adults with a rotator cuff disorder.

Methods and analysis We are conducting a large multicentre randomised controlled trial (2×2 factorial design). We will recruit adults ≥18 years with a new episode of shoulder pain attributable to a rotator cuff disorder as per British Elbow and Shoulder Society guidelines, not currently receiving physiotherapy or being considered for surgery, from at least eight UK National Health Service primary care-based musculoskeletal and related physiotherapy services. Participants (n=704) will be randomised (centralised computer-generated 1:1:1:1 allocation ratio) to one of four interventions: (1) progressive exercise (≤6 physiotherapy sessions); (2) best practice advice (one physiotherapy session); (3) corticosteroid injection then progressive exercise (≤6 sessions) or (4) corticosteroid injection then best practice advice (one session). The primary outcome is the mean difference in Shoulder Pain and Disability Index (SPADI) total score at 12 months. Secondary outcomes are: pain and function SPADI subdomains; health-related quality of life (Five-Level version of the EuroQol EQ-5D-5L); sleep disturbance; return to activity; global impression of change; health resource use; out-of-pocket expenses; work disability. A parallel within-trial economic evaluation will be conducted. The primary analysis will be intention to treat.

Ethics and dissemination Research Ethics Committee approval (REC: 16/SC/0508) has been obtained. Results of the main trial and secondary outcomes will be submitted for publication in a peer-reviewed journal.

Trial registration number ISRCTN16539266; EudraCT number: 2016-002991-28.

  • rehabilitation medicine
  • primary care
  • pain management
  • musculoskeletal disorders

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

https://doi.org/10.1136/bmjopen-2017-018004

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    Footnotes

    • Contributors SH and SEL are cochief investigators. DK, MD, SD, AC, WH, AJ, CL, ZH and KB are co-applicants on the grant awarded by the National Institute of Health Research Health Technology Assessment (15/26/06) and were involved in design of the study and its implementation, as were LC as trial manager, MMS as trial statistician, HS and PH as research physiotherapists. SH, DK, SD, MMS, MD and SEL were involved in writing the manuscript. All authors have read and approved the final manuscript.

    • Funding This research is funded by the National Institute of Health Research Health Technology Assessment Programme (15/26/06).

    • Disclaimer The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.

    • Competing interests None declared.

    • Ethics approval Berkshire B Research Ethics Committee (REC: 16/SC/0508).

    • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.