SHoes for Adolescent PatEllofemoral pain: study protocol for the SHAPE Australian community-based, randomised clinical trial
Abstract
Introduction: Patellofemoral pain affects one-third of adolescents, with most experiencing symptoms into adulthood. Guidelines recommend exercise and foot orthoses based on clinical trials in adults; however, these approaches have been found to be ineffective and have poor adherence in adolescents. 'Minimalist' shoes can reduce patellofemoral joint forces in adults; and may therefore be a promising low burden management approach for patellofemoral pain. This article outlines the protocol for a randomised clinical trial (RCT) that aims to determine if minimalist footwear improves pain, function and other symptoms compared with motion control shoes, in adolescents with patellofemoral pain.
Methods and analysis: This is a 3-month, pragmatic, two-arm parallel group, comparative effectiveness, superiority RCT conducted in Melbourne, Australia. We are recruiting 158 participants aged between 12 and 19 years with patellofemoral pain from the community. Following baseline assessment, participants are randomised to receive either minimalist shoes (intervention group) or motion control shoes (control group, given that clinicians typically advocate motion control shoes for patellofemoral pain). Participants choose one pair of shoes in their allocated group from two colour options. They are advised to wear their study shoes for all planned sports and exercise-based activities over the subsequent 3 months and are also advised that they may wear them as much as desired at other times. The…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 158 participants or records.
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