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

BMC Musculoskeletal Disorders

Study Protocol

Jo Adams¹  Joanne Lord²  Francine Toye³  Vivien Nichols⁴  Martin R Underwood⁴  Christopher McConkey⁴  Peter Heine⁴  Sukhdeep Dosanjh⁴  Esther M Williamson⁴  Chris Bridle⁴  Mark A Williams⁴  Sarah E Lamb⁵ 

[1] Faculty of Health Sciences, University of Southampton, SO17 1BJ, Highfield, Southampton, Hampshire, UK;Health Economics Research Group, Brunel University, UB8 3PH, Uxbridge, Middlesex, UK;Nuffield Orthopaedic Centre, Windmill Rd, OX3 7HE, Headington, Oxford, Oxfordshire, UK;Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, CV4 7AL, Coventry, UK;Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, CV4 7AL, Coventry, UK;Kadoorie Critical Care Research Centre, John Radcliffe Hospital, OX3 9DU, Oxford, UK;

关键词: Randomised controlled trial;    Rheumatoid arthritis;    Exercise;    Hand;    Rehabilitation;   

DOI  :  10.1186/1471-2474-13-230

 received in 2012-10-09, accepted in 2012-11-02,  发布年份 2012

来源: Springer

【 摘 要 】

BackgroundRheumatoid 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/design480 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.DiscussionThis 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 registrationCurrent Controlled Trials ISRCTN89936343

【 授权许可】

Unknown   
© Trial Team et al.; licensee BioMed Central Ltd. 2012. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.