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A randomised controlled trial into the effectiveness and efficacy of splints in thumb based osteoarthritis.

OTTER II is a multicentre, single blind, randomised controlled clinical effectiveness and efficacy trial. Occupational therapy and physiotherapy centres in England will recruit participants aged 30 years and over with clinical thumb base OA. People with symptomatic thumb base OA and moderate to severe thumb base pain will be allocated to either 8 weeks of self-management; 8 weeks of self-management plus a supportive splint, or 8 weeks of self-management plus a mobilising splint. Follow up will be for 12 weeks from baseline.The primary outcome is the AUSCAN hand pain scale. The study end point is 8 weeks. Outcomes will be collected at baseline; 4 weeks; 8 weeks; and 12 weeks. Findings will improve the management of thumb base OA and add to understanding contextual aspects of rehabilitation and self-management strategies for OA. The study design builds on experience of conducting the OTTER pilot study and the practical implications for supporting clinicians across the UK to recruit into and deliver a fully powered randomised control effectiveness and efficacy trial. This design is a straightforward pragmatic design that will be able to be supported by NHS out-patient clinics and associated booking procedures throughout the NHS. The study has been informed by patients and the public and is designed according to the recommendations for the conduct of randomised controlled trials of osteoarthritis.