Abstract
BackgroundStructural features of lateral tibiofemoral (TF) joint osteoarthritis (OA) occur in up to half of all people with knee OA, and co-existing lateral TF OA is associated with worse knee pain in people with mixed compartmental knee OA. Clinical guidelines for management of knee OA advocate advice about appropriate footwear, yet there is no research evaluating which types of footwear are best for managing pain associated with lateral TF OA. Biomechanical evidence suggests that “motion-control” footwear, which possess midsoles that are stiffer medially compared to laterally, may shift load away from the lateral compartment of the knee and thus may reduce knee pain associated with lateral TF OA. The primary aim of this study is to compare the effects of motion-control shoes to neutral shoes on knee pain in people with predominantly lateral TF OA.MethodsThis will be an assessor- and participant-blinded, two-arm, comparative effectiveness randomized controlled trial (RCT) conducted in Melbourne, Australia. We will recruit a minimum of 92 people with painful lateral TF OA from the community. Participants will be randomly allocated to receive either motion-control shoes or neutral shoes and will be instructed to wear their allocated shoes for a minimum of 6 h per day for 6 months. The primary outcome is change in self-reported knee pain on walking, measured using a numerical rating scale, assessed at baseline and 6 months. Secondary outcomes include other measures of knee pain, physical function, quality of life, participant-perceived change in pain and function, and physical activity levels.DiscussionThis study will compare the efficacy of motion-control shoes to neutral shoes for people with painful lateral TF OA. Findings will be the first to provide evidence of the effects of footwear on knee pain in this important subgroup of people with knee OA and allow clinicians to provide accurate advice about the most appropriate footwear for managing pain associated with lateral TF OA.Trial registrationThis trial has been prospectively registered by the Australian New Zealand Clinical Trials Registry on 15/11/2018 (reference: ACTRN12618001864213).
Highlights
Structural features of lateral tibiofemoral (TF) joint osteoarthritis (OA) occur in up to half of all people with knee OA, and co-existing lateral TF OA is associated with worse knee pain in people with mixed compartmental knee OA
The knee adduction moment is a valid indicator of medial-to-lateral tibiofemoral (TF) joint load distribution [4], and it is this imbalance of force towards the medial compartment during loadbearing that likely explains why the medial TF compartment is more frequently affected by OA than the lateral compartment [5]
This will be the first randomized controlled trial (RCT) to test the efficacy of footwear for managing pain associated with predominantly lateral TF OA
Summary
Study design This study is a participant- and assessor-blinded, twoarm, comparative effectiveness RCT. At the 6-month follow-up assessment, participants rate their perceived overall level of adherence with wearing their allocated shoes (for a minimum of 6 h per day over the previous 6 months) on an 11-point NRS (with terminal descriptors of ‘shoes not worn all’ and ‘shoes worn completely as Sample size calculations We aim to detect the minimal clinically important difference on the primary outcome between groups (1.8 (out of 10) for NRS pain [49]). To assess whether the effect of shoe allocation on the primary outcome is moderated by any of KL grade, FPI score, knee alignment, or baseline KOOS patellofemoral pain and OA score, appropriate interaction terms between randomised group and each of these variables will be included in regression models for the primary outcome, for each potential effect modifier separately
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
