Osteoarthritis Thumb Therapy II Trial (OTTER II trial)

• Research type

  Research Study

• Full title

  Osteoarthritis Thumb Therapy trial. A randomised controlled trial into the effectiveness and efficacy of splints in thumb base osteoarthritis.

• IRAS ID

  198227

• Contact name

  Joanna Adams

• Contact email

  ja@soton.ac.uk

• Sponsor organisation

  Southampton University

• ISRCTN Number

  ISRCTN54744256

• Duration of Study in the UK

  2 years, 8 months, 30 days

• Research summary

  Symptomatic thumb base OA affects 20% of the population over 55 years, causing more pain, work disability, reduced quality of life and function than OA elsewhere in the hand. International experts recommend splinting for hand OA but there is limited evidence from robust trials to support this.

  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

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  16/SC/0188

• Date of REC Opinion

  4 May 2016

• REC opinion

  Favourable Opinion