The Osteoarthritis Thumb Therapy Trial (OTTER II):: A study protocol for a three arm multi centre randomised placebo controlled trial of the clinical effectiveness and efficacy and cost effectiveness of splints for symptomatic thumb base osteoarthritis

Introduction: the economic cost of osteoarthritis (OA) is high. At least 4.4 million people have hand OA in the UK. Symptomatic thumb base OA affects 20% of people over 55 years, causing more pain, work and functional disability than OA elsewhere in the hand. Most evidence-based guidelines recommend splinting for hand OA. Splints that support or immobilise the thumb base are routinely used despite there being limited evidence on their effectivenss. The potential effects of placebo interventions in OA are acknowledged, but few studies investigate the clinical efficacy of rehabilitation interventions nor the impact of any placebo effects associated with splints. Methods and analysis: participants aged 30 years and over with symptomatic thumb base OA will be recruited into the trial from secondary care occupational therapy and physiotherapy centres. Following informed consent, participants will complete a baseline questionnaire and then be randomised into one of three treatment arms: a self-management programme, a self-management programme plus a verum thumb splint, or a self-management programme plus a placebo thumb splint. The primary outcome is the AUSCAN hand pain scale. The study end point is 8 weeks after baseline. Baseline assessments will be carried out prior to randomisation and outcomes collected at 4; 8 and 12 weeks. Cost effectiveness analysis will be conducted and individual qualitative interviews conducted with up to 40 participants after 8 weeks to explore perceptions and outcome expectations of verum and placebo splints and exercise. Ethics and eissemination: South Central - Oxford C Research Ethics Committee approved this study (16/SC/0188). The findings will be disseminated to health professional conferences, journals and lay publications for patientorganisations. The research will contribute to improving the management of thumb base OA andhelp clinicians and patients make informed decisions about the value of different interventions.