Abstract
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
Highlights
Rheumatoid Arthritis (RA) commonly affects the hands and wrists with inflammation, deformity, pain, weakness and restricted mobility leading to reduced function
This paper describes the design and development of a trial protocol of a complex intervention study based in therapy out-patient departments
This paper describes the trial protocol of a large pragmatic randomised controlled trial to evaluate 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
Summary
Impairment and dysfunction of hands and upper limbs are key concerns for patients with RA and optimal conservative management has yet to be defined and documented. JA participated in the conception, design and conduct of the study, obtaining funding and will participate in interpretation of data. SEL is chief investigator, participated in conception and design of the study, initial drafting of manuscript, obtaining funding, and will participate in analysis and interpretation of data. CM participated in the design of the study, obtaining funding, drafting of the statistical analysis section of the manuscript and will conduct the statistical analyses. VN participated in the design and data collection for the qualitative study, drafting of the qualitative section of the manuscript and will conduct the qualitative study analysis. MAW participated in the design and conduct of the study, lead drafting of the manuscript, and will participate in analysis and interpretation of data. Trial Steering Committee Prof Alison Hammond (Chair), Dr Chris Deighton, Dr Chris McCarthy, Prof Sallie Lamb, Dr Mark Williams, Mr John Wright (User representative)
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