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

Abstract

Background There 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. Methods Twenty-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. Discussion This 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 registration Australian New Zealand Clinical Trials Registry reference: ACTRN12621001525875, Date registered: 9th November 2021.

Flat flexible school shoes for adolescents with patellofemoral pain: a randomised, assessor-blinded, parallel-group feasibility trial

“…The research was developed and is reported according to the Standard Protocol Items: Recommendations for Interventional Trials 2013 statement17 and the Consolidated Standard of Reporting Trials 2010 guidelines for randomised pilot and feasibility trials 18. The published protocol for this feasibility trial provides a detailed account of the methodology 19…”

“…Secondary self-reported outcome measures were collected at baseline, 6 weeks and 12 weeks via Qualtrics. Further detail of each outcome measure are provided in the published protocol 19. In brief, secondary outcome measures included: (1) usual and worst pain severity over the past week using an 11-point numeric rating scale (minimal clinically important difference (MCID) =1.2 points)25 26; (2) all subscales of the Knee Injury and Osteoarthritis Outcome Score Child (KOOS-Child) (MCID=14.6–22.6 points)27; (3) Knee Injury and Osteoarthritis Outcome Score Patellofemoral (KOOS-PF) (MCID=16.4 points)28; (4) Anterior Knee Pain Scale (AKPS) (MCID=10 points)26 29; (5) Youth Quality of Life Short Form30 and (6) Global Rating of Change 31…”

“…18 The published protocol for this feasibility trial provides a detailed account of the methodology. 19 The trial was prospectively registered on the Australian and New Zealand Clinical Trials Registry (ACTRN12621001525875, date registered: 9 November 2021). Written informed consent was obtained from all participants and their parents/guardians (for those under the age of 18 years) prior to participation.…”