HAPPi Kneecaps! A double-blind, randomised, parallel group superiority trial investigating the effects of sHoe inserts for adolescents with patellofemoral PaIn: phase II feasibility study

Journal of Foot and Ankle Research

Marienke van Middelkoop¹  Steven J. Kamper²  Kay M. Crossley³  Anne J. Smith⁴  Hylton B. Menz⁵  Kylie Tucker⁶  Isobel C. O’Sullivan⁷  Bill Vicenzino⁷  Melinda M. Franettovich Smith⁷  Nathalia Costa⁷  Natalie J. Collins⁸  Karina T. O’Leary⁹ 

[1] Department of General Practice, Erasmus MC Medical University Center, Rotterdam, The Netherlands;Faculty of Medicine and Health, The University of Sydney, Sydney, Australia;Nepean Blue Mountains Local Health District, Penrith, Australia;La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia;School of Allied Health, Curtin University, Perth, Australia;School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia;School of Biomedical Sciences, The University of Queensland, Brisbane, Australia;School of Health and Rehabilitation Sciences: Physiotherapy, The University of Queensland, Brisbane, Australia;School of Health and Rehabilitation Sciences: Physiotherapy, The University of Queensland, Brisbane, Australia;La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia;Surgical Treatment and Rehabilitation Services, Metro North Hospital and Health Service, Herston, Australia;Faculty of Health and Behavioural Sciences, The University of Queensland, Brisbane, Australia;

关键词: Patellofemoral pain;    Adolescents;    Foot orthoses;    Physiotherapy;    Feasibility;   

DOI  :  10.1186/s13047-021-00498-0

来源: Springer

【 摘 要 】

BackgroundPatellofemoral pain (PFP) affects one-third of adolescents and can persist into adulthood, negatively impacting health and quality of life. Foot orthoses are a recommended treatment for adults with PFP, but have not been evaluated in adolescents. The primary objective was to determine the feasibility of conducting a full-scale randomised controlled trial (RCT) evaluating effects of contoured, prefabricated foot orthoses on knee pain severity and patient-perceived global change, compared to flat insoles. The secondary objective was to describe outcomes on a range of patient-reported outcome measures.MethodsWe recruited adolescents aged 12–18 years with PFP of ≥2 months duration into a double-blind, randomised, parallel-group feasibility trial. Participants were randomised to receive prefabricated contoured foot orthoses or flat shoe insoles, and followed for 3 months. Participants and outcome assessors were blinded to group allocation. Primary outcomes were feasibility of a full-scale RCT (number of eligible/enrolled volunteers; recruitment rate; adherence with the intervention and logbook completion; adverse effects; success of blinding; drop-out rate), and credibility and expectancy of interventions. Secondary outcomes were patient-reported measures of pain, symptoms, function, quality of life, global rating of change, patient acceptable symptom state, and use of co-interventions.Results36 out of 279 (12.9%) volunteers (27 female, mean (SD) age 15 (2) years, body mass 60 (13) kg) were eligible and enrolled, at a recruitment rate of 1.2 participants/week. 17 participants were randomised to receive foot orthoses, and 19 to flat insoles. 15 participants returned logbooks; 7/15 (47%) adhered to the intervention. No serious adverse events were reported. 28% (10/36, 4 pandemic-related) of participants dropped out before 3 months. Blinding was successful. Both groups found the inserts to be credible.ConclusionsBased on a priori criteria for feasibility, findings suggest that a full-scale RCT comparing contoured foot orthoses to flat insoles in adolescents with PFP would not be feasible using the current protocol. Prior to conducting a full-scale RCT, feasibility issues should be addressed, with protocol modifications to facilitate participant retention, logbook completion and shoe insert wear.Trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12619000957190. Date registered: 8/07/2019.

【 授权许可】

CC BY