To determine the feasibility of a full-scale randomized controlled trial (RCT) comparing foot orthoses and footwear to footwear alone in individuals with patellofemoral (PF) osteoarthritis (OA).
This 4-month, parallel, 2-arm pilot trial took place in Brisbane, Queensland and Hobart, Tasmania (August 2014 to October 2016). Forty-six individuals with PF OA were randomized by concealed allocation to foot orthoses plus prescribed footwear (n = 24) or prescribed footwear alone (n = 22). Study feasibility was the primary outcome (e.g., recruitment rate, adherence, adverse events, dropout rate). Secondary outcomes included patient-reported outcome measures of pain, function, and quality of life. Effect sizes with 95% confidence intervals were calculated at the 4-month primary end point (standardized mean differences for between-group effects; standardized response mean for within-group effects).
From 782 volunteers, 47 were eligible (6%), and 46 participated. One participant withdrew (2%), and 1 (2%) was lost to follow-up. Intervention adherence was high for both groups (9-10 hours of wear per day). No serious adverse events were reported. More than 80% of questionnaires were completed at 4 months. Between-group effect sizes for patient-reported outcome measures were typically small, while moderate-to-large within-group response effects were observed in both groups.
A full-scale RCT for PF OA is feasible with modifications to eligibility criteria. However, our observed small between-group effect sizes, combined with moderate-to-large within-group responses for both interventions, indicate that a full-scale trial is unlikely to find clinically meaningful differences. Secondary outcomes suggest that both interventions can be recommended for individuals with PF OA.