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Our trial will determine the clinical and cost-effectiveness of adding knee bracing (matched to patients\u2019 clinical and radiographic presentation and with adherence support) to a package of advice, written information and exercise instruction delivered by physiotherapists.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>A multicentre, pragmatic, two-parallel group, single-blind, superiority, randomised controlled trial with internal pilot and nested qualitative study. 434 eligible participants with symptomatic knee OA identified from general practice, physiotherapy referrals and self-referral will be randomised 1:1 to advice, written information and exercise instruction and knee brace versus advice, written information and exercise instruction alone. The primary analysis will be intention-to-treat comparing treatment arms on the primary outcome (Knee Osteoarthritis Outcomes Score (KOOS)-5) (composite knee score) at the primary endpoint (6 months) adjusted for prespecified covariates. Secondary analysis of KOOS subscales (pain, other symptoms, activities of daily living, function in sport and recreation, knee-related quality of life), self-reported pain, instability (buckling), treatment response, physical activity, social participation, self-efficacy and treatment acceptability will occur at 3, 6, and 12 months postrandomisation. Analysis of covariance and logistic regression will model continuous and dichotomous outcomes, respectively. Treatment effect estimates will be presented as mean differences or ORs with 95% CIs. Economic evaluation will estimate cost-effectiveness. Semistructured interviews to explore acceptability and experiences of trial interventions will be conducted with participants and physiotherapists delivering interventions.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>North West Preston Research Ethics Committee, the Health Research Authority and Health and Care Research in Wales approved the study (REC Reference: 19\/NW\/0183; IRAS Reference: 247370). This protocol has been coproduced with stakeholders including patients and public. Findings will be disseminated to patients and a range of stakeholders.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"ISRCTN28555470\">ISRCTN28555470<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2020-048196","type":"journal-article","created":{"date-parts":[[2021,3,26]],"date-time":"2021-03-26T13:47:36Z","timestamp":1616766456000},"page":"e048196","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":10,"title":["Clinical and cost-effectiveness of bracing in symptomatic knee osteoarthritis management: protocol for a multicentre, primary care, randomised, parallel-group, superiority trial"],"prefix":"10.1136","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0374-2862","authenticated-orcid":false,"given":"Melanie A","family":"Holden","sequence":"first","affiliation":[{"name":"Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Callaghan","sequence":"additional","affiliation":[{"name":"Faculty of Health, Psychology & Social Care, Manchester Metropolitan University, Manchester, Greater Manchester, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2668-2447","authenticated-orcid":false,"given":"David","family":"Felson","sequence":"additional","affiliation":[{"name":"Boston University School of Medicine, Boston, Massachusetts, USA"},{"name":"Research in OsteoArthritis Manchester (ROAM), Centre for Epidemiology Versus Arthritis, Centre for Musculoskeletal Research, Institute of Inflammation and Repair, The University of Manchester, Manchester, Manchester, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fraser","family":"Birrell","sequence":"additional","affiliation":[{"name":"Medical Research Council Versus Arthritis Centre for Integrated Research into Musculoskeletal Ageing, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK"},{"name":"Northumbria Healthcare NHS Foundation Trust, North Shields, Tyne and Wear, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elaine","family":"Nicholls","sequence":"additional","affiliation":[{"name":"Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, UK"},{"name":"Clinical Trials Unit, Keele University, Keele, Staffordshire, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sue","family":"Jowett","sequence":"additional","affiliation":[{"name":"Health Economics Unit, University of Birmingham, Birmingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J","family":"Kigozi","sequence":"additional","affiliation":[{"name":"Health Economics Unit, University of Birmingham, Birmingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"McBeth","sequence":"additional","affiliation":[{"name":"Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, Manchester, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Belinda","family":"Borrelli","sequence":"additional","affiliation":[{"name":"Henry M. 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