A combined program of education plus exercise versus general advice for ankle osteoarthritis: A feasibility randomised controlled trial

Background: Unlike hip and knee OA, there is little evidence to guide the management of ankle osteoarthritis (OA) and there are no clinical guidelines for ankle OA. Regardless of the body region, guidelines for treating OA typically include education, weight loss and exercise as the key components of management. Such an intervention has not been investigated in people with ankle OA. Objectives: To determine the feasibility of conducting a randomised controlled trial (RCT) that compares physiotherapist-delivered education plus exercise to physiotherapist-delivered general advice for people with ankle OA. Secondarily, to inform planning for future RCTs. Design: A randomised parallel-group feasibility trial. Method: Study participants were recruited, assessed for eligibility, and randomised using 1:1 concealed allocation to receive either physiotherapist-delivered education plus exercise, or physiotherapist-delivered general advice. Primary feasibility outcomes were evaluated based on predetermined feasibility criteria. Secondary participant- reported and physical outcomes were collected to inform the design of future RCTs. Results: Thirty participants (67% (n = 20) women, mean (standard deviation) age: 66.1 (11.5) years) were randomised. Data for key feasibility outcomes met a priori feasibility criteria: consent rate (97%), participant adherence with their allocated intervention arm (71%), fidelity of the intervention (94%) and rate of completion of outcome measures at 3 months (87%). Conclusions: This study demonstrates that it is feasible to run an adequately powered RCT comparing physiotherapist-delivered education plus exercise versus physiotherapist-delivered general advice for people with ankle OA. Study data will inform the planning of a full-scale RCT.