Foot Orthoses and Footwear for the Management of Patellofemoral Osteoarthritis: A Pilot Randomized Trial.
TL;DR: 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).
Abstract: Determine the feasibility of a full-scale randomised controlled trial (RCT) comparing foot orthoses and footwear to footwear alone in people with patellofemoral osteoarthritis (PFOA). This four-month, parallel, two-arm pilot trial took place in Brisbane, Queensland and Hobart, Tasmania (August 2014 to October 2016). Forty-six people with PFOA were randomized by concealed allocation to: (i) foot orthoses plus prescribed footwear (n=24); or (ii) prescribed footwear (n=22). Study feasibility was the primary outcome (e.g. recruitment rate, adherence, adverse events, drop-out rate). Secondary outcomes included patient-reported outcome measures of pain, function and quality of life. Effect sizes with 95% confidence intervals were calculated at four months (primary end-point) (standardized mean differences (SMD) for between-group effects; standardized response means (SRM) 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 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 PFOA 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 people with PFOA.
Summary (1 min read)
12 Foot orthoses and footwear for the management of patellofemoral
- In-kind support for the footwear 18 utilized in this study was provided by New Balance Australia, and for the foot orthoses by 19 Orthema Australasia and Orthema Switzerland.
- Study feasibility was the primary outcome (e.g. recruitment rate, adherence, 11 adverse events, drop-out rate).
- Between-group effect sizes for patient-reported 20 outcome measures were typically small, while moderate to large within-group response effects 21 were observed in both groups.
4 There was no clinically meaningful difference between footwear and footwear plus foot
- All rights reserved 1 INTRODUCTION 2 3 Worldwide, osteoarthritis (OA) is a leading cause of musculoskeletal pain and disability , most 4 frequently affecting the knee .
- A sample size of 22 participants per group was established based on 8 feasibility with respect to time and funding .
- All participants completed patient-reported outcome measures at baseline, two and four 3 months.
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