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Open Access Highly Accessed Study protocol

Strengthening and stretching for rheumatoid arthritis of the hand (SARAH): design of a randomised controlled trial of a hand and upper limb exercise intervention - ISRCTN89936343

Sarah Trial Team, Jo Adams2, Chris Bridle1, Sukhdeep Dosanjh1, Peter Heine1, Sarah E Lamb15*, Joanne Lord3, Christopher McConkey1, Vivien Nichols1, Francine Toye4, Martin R Underwood1, Mark A Williams1 and Esther M Williamson1

Author Affiliations

1 Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry CV4 7AL, UK

2 Faculty of Health Sciences, University of Southampton, Highfield, Southampton, Hampshire, SO17 1BJ, UK

3 Health Economics Research Group, Brunel University, Uxbridge, Middlesex, UB8 3PH, UK

4 Nuffield Orthopaedic Centre, Windmill Rd, Headington, Oxford, Oxfordshire, OX3 7HE, UK

5 Kadoorie Critical Care Research Centre, John Radcliffe Hospital, Oxford OX3 9DU, UK

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BMC Musculoskeletal Disorders 2012, 13:230  doi:10.1186/1471-2474-13-230

Published: 24 November 2012

Abstract

Background

Rheumatoid Arthritis (RA) commonly affects the hands and wrists with inflammation, deformity, pain, weakness and restricted mobility leading to reduced function. The effectiveness of exercise for RA hands is uncertain, although evidence from small scale studies is promising. The Strengthening And Stretching for Rheumatoid Arthritis of the Hand (SARAH) trial is a pragmatic, multi-centre randomised controlled trial evaluating the clinical and cost effectiveness of adding an optimised exercise programme for hands and upper limbs to best practice usual care for patients with RA.

Methods/design

480 participants with problematic RA hands will be recruited through 17 NHS trusts. Treatments will be provided by physiotherapists and occupational therapists. Participants will be individually randomised to receive either best practice usual care (joint protection advice, general exercise advice, functional splinting and assistive devices) or best practice usual care supplemented with an individualised exercise programme of strengthening and stretching exercises. The study assessors will be blinded to treatment allocation and will follow participants up at four and 12 months. The primary outcome measure is the Hand function subscale of the Michigan Hand Outcome Questionnaire, and secondary outcomes include hand and wrist impairment measures, quality of life, and resource use. Economic and qualitative studies will also be carried out in parallel.

Discussion

This paper describes the design and development of a trial protocol of a complex intervention study based in therapy out-patient departments. The findings will provide evidence to support or refute the use of an optimised exercise programme for RA of the hand in addition to best practice usual care.

Trial registration

Current Controlled Trials ISRCTN89936343

Keywords:
Randomised controlled trial; Rheumatoid arthritis; Exercise; Hand; Rehabilitation