None listed
Conditions
Brief summary
Ankle osteoarthritis is a serious health problem that causes disabling pain and limits performance of daily, recreational and occupational activities; however, little is known about how to manage it. The aim of this study is to establish the feasibility of conducting a full-scale randomised controlled trial investigating the addition of foot orthoses and education to usual care, compared to usual care alone for people with ankle osteoarthritis, and to collect quantitative and qualitative data to inform a future RCT. Key feasibility outcomes include consent rate, participant attendance at initial orthoses and education appointment, intervention fidelity and rate of completion of 3-month outcome measures. Findings from this study will improve the management of ankle osteoarthritis by establishing the feasibility of running a full-scale randomised controlled trial to investigate foot orthoses and education in this population.
Interventions
Usual care plus foot orthoses and education intervention: Participants will receive two pairs of prefabricated contoured foot orthoses with inbuilt arch support and varus wedging that are fitted to participants and the shoes they most commonly wear. Participants will be offered up to 3 face-to-face appointments to fit the orthoses and make adjustments for comfort. They will be provided with verbal and written information on using and adapting to the orthoses, and encouraged to wear the orthoses as much as possible. Participants will also receive verbal and written education (specifically designed for the study) about their ankle OA including information about the anatomy of the ankle; explaining ankle OA, symptoms, diagnosis, imaging and contributing factors; guidelines for OA management and physical activity; the role and importance of exercise; and strategies to manage symptoms. The first appointment will be approximately 1 hour in length, and the following up appointments will be approximately 30 minutes in length. Appointments will be separated by approximately 1-2 weeks. Participants will be asked to continue with their usual care of their ankle OA, in addition to following the education provided and using the orthoses. They will receive weekly emails over the 3-month study period to maintain engagement and collect information on orthoses wear time (adherence), usual care and any treatment-related adverse events. The intervention will be delivered by physiotherapists with over 5 years of musculoskeletal clinical experience. Physiotherapists will record appointment attendance, details of the orthoses and any adverse events. Fidelity delivering the foot orthoses and education intervention will be observed by a researcher not involved in the delivery of the intervention.
Sponsors
Study design
Eligibility
Inclusion criteria
a) aged 18 years or older b) ankle joint pain on most days for the last 3 months c) a clinical diagnosis of ankle OA d) greater than or equal to Kellgren & Lawrence scale OA grade 2 at the subtalar and/or talocrural joints e) able to understand verbal and written English
Exclusion criteria
a) pain elsewhere in the body that is currently more severe than their ankle pain b) currently wearing contoured foot orthoses c) ankle arthroscopy/debridement or intra-articular injection in the last 3 months d) previous ankle arthrodesis or total ankle joint replacement on the affected ankle