Protocol for a randomised, assessor-blinded, parallel group feasibility trial of flat flexible school shoes for adolescents with patellofemoral pain

Abstract

BackgroundThere are limited evidence-based treatment options for adolescents with patellofemoral pain (PFP). Flat, flexible footwear have been shown to reduce patellofemoral joint loading and pain in adults with PFP. The efficacy of this intervention in adolescents with PFP is not established. The primary aim of this study is to determine the feasibility of conducting a large-scale randomised controlled trial (RCT) of the effect of flat, flexible school footwear, when compared to traditional school footwear, in adolescents with PFP. The secondary aim is to describe changes in self-reported outcome measures for adolescents with PFP while wearing flat, flexible footwear when compared to traditional school shoes.MethodsTwenty-four adolescents with PFP will be recruited from the community. Following baseline assessment, participants will be randomly allocated to receive either (i) flat, flexible school footwear or, (ii) traditional school footwear. Participants will wear the shoe as per school requirements throughout a 12-week intervention period. Feasibility will be assessed with (i) ≥ 75% adherence to allocated shoe wear of their total weekly school wear time, (ii) a recruitment rate of one participant per fortnight, and (iii) a dropout rate of ≤ 20%. Patient reported outcome measures will describe changes in knee pain, function, quality of life and global rating of change at 6 and 12 weeks. Descriptive statistics will be used for the primary outcomes of feasibility.DiscussionThis study will determine the feasibility of conducting a large scale RCT evaluating the effect of flat, flexible school shoes for adolescents with PFP. A full-scale study will guide evidence-based management of adolescent PFP.Trial registrationAustralian New Zealand Clinical Trials Registry reference: ACTRN12621001525875, Date registered: 9th November 2021.