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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\u2010scale randomised controlled trial (RCT) evaluating effects of contoured, prefabricated foot orthoses on knee pain severity and patient\u2010perceived global change, compared to flat insoles. The secondary objective was to describe outcomes on a range of patient\u2010reported outcome measures.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We recruited adolescents aged 12\u201318\u2009years with PFP of \u22652\u2009months duration into a double\u2010blind, randomised, parallel\u2010group feasibility trial. Participants were randomised to receive prefabricated contoured foot orthoses or flat shoe insoles, and followed for 3\u2009months. Participants and outcome assessors were blinded to group allocation. Primary outcomes were feasibility of a full\u2010scale RCT (number of eligible\/enrolled volunteers; recruitment rate; adherence with the intervention and logbook completion; adverse effects; success of blinding; drop\u2010out rate), and credibility and expectancy of interventions. Secondary outcomes were patient\u2010reported measures of pain, symptoms, function, quality of life, global rating of change, patient acceptable symptom state, and use of co\u2010interventions.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>36 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\u2010related) of participants dropped out before 3\u2009months. Blinding was successful. Both groups found the inserts to be credible.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Based on a priori criteria for feasibility, findings suggest that a full\u2010scale 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\u2010scale RCT, feasibility issues should be addressed, with protocol modifications to facilitate participant retention, logbook completion and shoe insert wear.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      Australian New Zealand Clinical Trials Registry (ANZCTR):\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/www.anzctr.org.au\/Trial\/Registration\/TrialReview.aspx?id=377749\">ACTRN12619000957190<\/jats:ext-link>\n                      . Date registered: 8\/07\/2019.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13047-021-00498-0","type":"journal-article","created":{"date-parts":[[2021,12,10]],"date-time":"2021-12-10T04:02:31Z","timestamp":1639108951000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["HAPPi Kneecaps! A double\u2010blind, randomised, parallel group superiority trial investigating the effects of sHoe inserts for adolescents with patellofemoral PaIn: phase II feasibility study"],"prefix":"10.1002","volume":"14","author":[{"given":"Isobel C.","family":"O'Sullivan","sequence":"first","affiliation":[{"name":"School of Health and Rehabilitation Sciences: Physiotherapy The University of Queensland Brisbane Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kay M.","family":"Crossley","sequence":"additional","affiliation":[{"name":"La Trobe Sport and Exercise Medicine Research Centre School of Allied Health, Human Services and Sport La Trobe University Melbourne Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven J.","family":"Kamper","sequence":"additional","affiliation":[{"name":"Faculty of Medicine and Health The University of Sydney Sydney Australia"},{"name":"Nepean Blue Mountains Local Health District Penrith 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Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne J.","family":"Smith","sequence":"additional","affiliation":[{"name":"School of Allied Health Curtin University Perth Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kylie","family":"Tucker","sequence":"additional","affiliation":[{"name":"School of Biomedical Sciences The University of Queensland Brisbane Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karina T.","family":"O'Leary","sequence":"additional","affiliation":[{"name":"Surgical Treatment and Rehabilitation Services Metro North Hospital and Health Service Herston Australia"},{"name":"Faculty of Health and Behavioural Sciences The University of Queensland Brisbane Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nathalia","family":"Costa","sequence":"additional","affiliation":[{"name":"School of Health and Rehabilitation Sciences: Physiotherapy The University of 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All participants (and their parent\/guardian if aged under 18\u2009years) provided written informed consent prior to participation.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"BV is a voluntary (non-compensated) member by invitation on the Vasyli Think Tank. All other authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"64"}}