{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,12]],"date-time":"2026-09-12T04:15:40Z","timestamp":1789186540099,"version":"build-2803163510"},"reference-count":37,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2020,8,2]],"date-time":"2020-08-02T00:00:00Z","timestamp":1596326400000},"content-version":"vor","delay-in-days":214,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2020,1,1]],"date-time":"2020-01-01T00:00:00Z","timestamp":1577836800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2020,8,2]],"date-time":"2020-08-02T00:00:00Z","timestamp":1596326400000},"content-version":"vor","delay-in-days":214,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100000940","name":"Arthritis Australia","doi-asserted-by":"publisher","award":["Project Grant (Molly Saint Grant)"],"award-info":[{"award-number":["Project Grant (Molly Saint Grant)"]}],"id":[{"id":"10.13039\/501100000940","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001794","name":"The University of Queensland","doi-asserted-by":"crossref","award":["UQ Graduate School Scholarship"],"award-info":[{"award-number":["UQ Graduate School Scholarship"]}],"id":[{"id":"10.13039\/501100001794","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/501100001794","name":"The University of Queensland","doi-asserted-by":"crossref","award":["UQ Development Fellowship (UQFEL1832429)"],"award-info":[{"award-number":["UQ Development Fellowship (UQFEL1832429)"]}],"id":[{"id":"10.13039\/501100001794","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/501100000925","name":"National Health and Medical Research Council","doi-asserted-by":"publisher","award":["Senior Research Fellowship (1135995)"],"award-info":[{"award-number":["Senior Research Fellowship (1135995)"]}],"id":[{"id":"10.13039\/501100000925","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Journal of Foot and Ankle Research"],"published-print":{"date-parts":[[2020,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Patellofemoral pain (PFP) is a common cause of knee pain in adolescents, but there are limited evidence\u2010based treatment options for this population. Foot orthoses can improve pain and function in adults with PFP, and may be effective for adolescents. The primary aim of this study is to determine the feasibility of conducting a full\u2010scale randomised controlled trial (RCT) evaluating the effects of contoured foot orthoses on knee pain severity and patient\u2010perceived global change, compared to flat shoe insoles, in adolescents with PFP. The secondary aim is to provide an estimate of treatment effects for foot orthoses, compared to flat insoles, in adolescents with PFP.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This randomised, controlled, participant\u2010 and assessor\u2010blinded, feasibility trial has two parallel groups. Forty adolescents (aged 12\u201318\u2009years) with clinical symptoms of PFP will be recruited from Queensland, Australia. Participants will be randomised to receive either prefabricated contoured foot orthoses or flat shoe insoles. Both interventions will be fit by a physiotherapist, and worn for 3\u2009months. Feasibility will be evaluated through assessing willingness of volunteers to enrol, number of eligible participants, recruitment rate, adherence with the study protocol, adverse effects, success of blinding, and drop\u2010out rate. Secondary outcomes will evaluate knee\u2010related pain, symptoms, function, quality of life, global rating of change, patient acceptable symptom state, and use of co\u2010interventions, at 6\u2009weeks and 3\u2009months. Primary outcomes will be reported descriptively, while estimates of standard deviation and between\u2010group differences (with 95% confidence intervals) will be reported for secondary outcomes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>Findings of this study will inform the feasibility of a full\u2010scale RCT investigating the efficacy of contoured foot orthoses in adolescents with PFP. This full\u2010scale study is necessary to improve the evidence base for management of adolescent PFP, and enhance outcomes for this population.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration<\/jats:title><jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/www.anzctr.org.au\/Trial\/Registration\/TrialReview.aspx?id=377749&amp;isReview=true\">ACTRN12619000957190<\/jats:ext-link>.<\/jats:p><\/jats:sec>","DOI":"10.1186\/s13047-020-00417-9","type":"journal-article","created":{"date-parts":[[2020,8,2]],"date-time":"2020-08-02T20:02:31Z","timestamp":1596398551000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["HAPPi Kneecaps! Protocol for a participant\u2010 and assessor\u2010blinded, randomised, parallel group feasibility trial of foot orthoses for adolescents with patellofemoral pain"],"prefix":"10.1002","volume":"13","author":[{"given":"Isobel C.","family":"O'Sullivan","sequence":"first","affiliation":[{"name":"Division of Physiotherapy School of Health and Rehabilitation Sciences The University of Queensland 4072 Brisbane Queensland 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 College of Science, Health and Engineering La Trobe University Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven J.","family":"Kamper","sequence":"additional","affiliation":[{"name":"School of Public Health University of Sydney Camperdown New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marienke","family":"van Middelkoop","sequence":"additional","affiliation":[{"name":"Department of General Practice Erasmus MC University Medical Center Rotterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bill","family":"Vicenzino","sequence":"additional","affiliation":[{"name":"Division of Physiotherapy School of Health and Rehabilitation Sciences The University of Queensland 4072 Brisbane Queensland Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melinda M.","family":"Franettovich Smith","sequence":"additional","affiliation":[{"name":"Division of Physiotherapy School of Health and Rehabilitation Sciences The University of Queensland 4072 Brisbane Queensland Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hylton B.","family":"Menz","sequence":"additional","affiliation":[{"name":"Discipline of Podiatry School of Allied Health Human Services and Sport College of Science, Health and Engineering La Trobe University Melbourne Victoria Australia"},{"name":"La Trobe Sport and Exercise Medicine Research Centre School of Allied Health, Human Services and Sport College of Science, Health and Engineering La Trobe University Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne J.","family":"Smith","sequence":"additional","affiliation":[{"name":"School of Physiotherapy and Exercise Science Curtin University Perth Western Australia 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":"Division of Physiotherapy School of Health and Rehabilitation Sciences The University of Queensland 4072 Brisbane Queensland Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9950-0192","authenticated-orcid":false,"given":"Natalie J.","family":"Collins","sequence":"additional","affiliation":[{"name":"Division of Physiotherapy School of Health and Rehabilitation Sciences The University of Queensland 4072 Brisbane Queensland Australia"},{"name":"La Trobe Sport and Exercise Medicine Research Centre School of Allied Health, Human Services and Sport College of Science, Health and Engineering La Trobe University Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,8,2]]},"reference":[{"key":"e_1_2_14_2_1","doi-asserted-by":"publisher","DOI":"10.1136\/bjsports\u20102016\u2010096328"},{"key":"e_1_2_14_3_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0190892"},{"key":"e_1_2_14_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejpain.2003.08.001"},{"key":"e_1_2_14_5_1","doi-asserted-by":"publisher","DOI":"10.1186\/1471\u20102431\u201013\u2010191"},{"key":"e_1_2_14_6_1","doi-asserted-by":"publisher","DOI":"10.1177\/0363546515622456"},{"key":"e_1_2_14_7_1","doi-asserted-by":"publisher","DOI":"10.1097\/01241398-199801000-00021"},{"key":"e_1_2_14_8_1","doi-asserted-by":"publisher","DOI":"10.1136\/bjsports\u20102014\u2010093929"},{"key":"e_1_2_14_9_1","doi-asserted-by":"publisher","DOI":"10.1093\/ptj\/73.2.62"},{"key":"e_1_2_14_10_1","doi-asserted-by":"publisher","DOI":"10.1136\/bjsports\u20102018\u2010099397"},{"key":"e_1_2_14_11_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40279\u2010015\u20100364\u20101"},{"key":"e_1_2_14_12_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0079153"},{"key":"e_1_2_14_13_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.a1310"},{"key":"e_1_2_14_14_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.b4074"},{"key":"e_1_2_14_15_1","doi-asserted-by":"publisher","DOI":"10.1136\/bjsports\u20102016\u2010096384"},{"key":"e_1_2_14_16_1","doi-asserted-by":"publisher","DOI":"10.1136\/bjsports\u20102012\u2010091696"},{"key":"e_1_2_14_17_1","doi-asserted-by":"publisher","DOI":"10.1136\/bjsports\u20102015\u2010094664"},{"key":"e_1_2_14_18_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13047\u2010018\u20100304\u2010z"},{"key":"e_1_2_14_19_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.e7586"},{"key":"e_1_2_14_20_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.i5239"},{"key":"e_1_2_14_21_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen\u20102018\u2010025315"},{"key":"e_1_2_14_22_1","doi-asserted-by":"crossref","unstructured":"MatthewsM RathleffMS ClausA McPoilT NeeR CrossleyKM et al. Does foot mobility affect the outcome in the management of patellofemoral pain with foot orthoses versus hip exercises? A randomised clinical trial.Br J Sports Med.2020.https:\/\/doi.org\/10.1136\/bjsports\u20102019\u2010100935.","DOI":"10.1136\/bjsports-2019-100935"},{"key":"e_1_2_14_23_1","doi-asserted-by":"publisher","DOI":"10.1186\/1471\u20102288\u201010\u201067"},{"key":"e_1_2_14_24_1","doi-asserted-by":"publisher","DOI":"10.1186\/1471\u20102288\u201013\u2010104"},{"key":"e_1_2_14_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/0005\u20107916(72)90045\u20106"},{"key":"e_1_2_14_26_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0005\u20107916(00)00012\u20104"},{"key":"e_1_2_14_27_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.brat.2015.04.009"},{"key":"e_1_2_14_28_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaac.2014.09.012"},{"key":"e_1_2_14_29_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0003\u20109993(03)00613\u20100"},{"key":"e_1_2_14_30_1","doi-asserted-by":"publisher","DOI":"10.3109\/17453674.2012.747921"},{"key":"e_1_2_14_31_1","doi-asserted-by":"publisher","DOI":"10.1136\/bjsports\u20102013\u2010093164"},{"key":"e_1_2_14_32_1","doi-asserted-by":"publisher","DOI":"10.1136\/bjsports\u20102016\u2010096776"},{"key":"e_1_2_14_33_1","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2007.079798"},{"key":"e_1_2_14_34_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0749\u20108063(05)80366\u20104"},{"key":"e_1_2_14_35_1","doi-asserted-by":"publisher","DOI":"10.1006\/jado.2002.0470"},{"key":"e_1_2_14_36_1","doi-asserted-by":"publisher","DOI":"10.3109\/07853890109002087"},{"key":"e_1_2_14_37_1","doi-asserted-by":"publisher","DOI":"10.1186\/1757\u20101146\u20102\u201020"},{"key":"e_1_2_14_38_1","doi-asserted-by":"publisher","DOI":"10.2519\/jospt.2017.7326"}],"container-title":["Journal of Foot and Ankle Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13047-020-00417-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13047-020-00417-9\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13047-020-00417-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1186\/s13047-020-00417-9","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,2,2]],"date-time":"2024-02-02T05:18:22Z","timestamp":1706851102000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1186\/s13047-020-00417-9"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,1]]},"references-count":37,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2020,1]]}},"alternative-id":["10.1186\/s13047-020-00417-9"],"URL":"https:\/\/doi.org\/10.1186\/s13047-020-00417-9","archive":["Portico"],"relation":{},"ISSN":["1757-1146","1757-1146"],"issn-type":[{"value":"1757-1146","type":"print"},{"value":"1757-1146","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,1]]},"assertion":[{"value":"17 May 2020","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"22 July 2020","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"2 August 2020","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"Ethics approval was obtained through The University of Queensland\u2019s Human Research Ethics Committee (HREC No. 2018000159). All participants (and\/or their parent\/guardian) will provide written informed consent prior to participation in the study.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Bill Vicenzino is a voluntary (non-compensated) member by invitation on the Vasyli Think Tank. All other authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"50"}}