{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,13]],"date-time":"2026-01-13T23:57:04Z","timestamp":1768348624410,"version":"3.49.0"},"reference-count":51,"publisher":"BMJ","issue":"8","funder":[{"DOI":"10.13039\/501100000925","name":"National Health and Medical Research Council","doi-asserted-by":"publisher","award":["APP1145271"],"award-info":[{"award-number":["APP1145271"]}],"id":[{"id":"10.13039\/501100000925","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2019,7,17]]},"published-print":{"date-parts":[[2019,8]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Low back pain (LBP) is the leading cause of disability globally and its costs exceed those of cancer and diabetes combined. Recent evidence suggests that individualised cognitive and movement rehabilitation combined with lifestyle advice (cognitive functional therapy (CFT)) may produce larger and more sustained effects than traditional approaches, and movement sensor biofeedback may enhance outcomes. Therefore, this three-arm randomised controlled trial (RCT) aims to compare the clinical effectiveness and economic efficiency of individualised CFT delivered with or without movement sensor biofeedback, with usual care for patients with chronic, disabling LBP.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>Pragmatic, three-arm, randomised, parallel group, superiority RCT comparing usual care (n=164) with CFT (n=164) and CFT-plus-movement-sensor-biofeedback (n=164). Inclusion criteria include: adults with a current episode of LBP &gt;3 months; sought primary care \u22656 weeks ago for this episode of LBP; average LBP intensity of \u22654 (0\u201310 scale); at least moderate pain-related interference with work or daily activities. The CFT-only and CFT-plus-movement-sensor-biofeedback participants will receive seven treatment sessions over 12 weeks plus a \u2018booster\u2019 session at 26 weeks. All participants will be assessed at baseline, 3, 6, 13, 26, 40 and 52 weeks. The primary outcome is pain-related physical activity limitation (Roland Morris Disability Questionnaire). Linear mixed models will be used to assess the effect of treatment on physical activity limitation across all time points, with the primary comparison being a formal test of adjusted mean differences between groups at 13 weeks. For the economic (cost-utility) analysis, the primary outcome of clinical effect will be quality-adjusted life years measured across the 12-month follow-up using the EuroQol EQ-5D-5L .<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Approved by Curtin University Human Research Ethics Committee (HRE2018-0062, 6 Feb 2018). Study findings will be disseminated through publication in peer-reviewed journals and conference presentations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>Australian New Zealand Clinical Trials Registry (ACTRN12618001396213).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2019-031133","type":"journal-article","created":{"date-parts":[[2019,8,19]],"date-time":"2019-08-19T06:06:56Z","timestamp":1566194816000},"page":"e031133","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":33,"title":["RESTORE\u2014Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain: study protocol for a randomised controlled trial"],"prefix":"10.1136","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2429-9233","authenticated-orcid":false,"given":"Peter","family":"Kent","sequence":"first","affiliation":[{"name":"School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia"},{"name":"Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"P","family":"O'Sullivan","sequence":"additional","affiliation":[{"name":"School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"suffix":"Dr","given":"Anne","family":"Smith","sequence":"additional","affiliation":[{"name":"School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Terry","family":"Haines","sequence":"additional","affiliation":[{"name":"Faculty of Medicine, Nursing and Health Science, Monash University, Melbourne, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amity","family":"Campbell","sequence":"additional","affiliation":[{"name":"School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alison H","family":"McGregor","sequence":"additional","affiliation":[{"name":"Department of Surgery and Cancer, Imperial College London, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jan","family":"Hartvigsen","sequence":"additional","affiliation":[{"name":"Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark"},{"name":"Nordic Institute of Chiropractic and Clinical Biomechanics, Odense, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kieran","family":"O'Sullivan","sequence":"additional","affiliation":[{"name":"Sports Spine Centre, Aspetar Qatar Orthopaedic and Sports Medicine Hospital, Doha, Qatar"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alistair","family":"Vickery","sequence":"additional","affiliation":[{"name":"General Practice, The University of Western Australia, Crawley, Western Australia, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"JP","family":"Caneiro","sequence":"additional","affiliation":[{"name":"School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert","family":"Sch\u00fctze","sequence":"additional","affiliation":[{"name":"School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert A","family":"Laird","sequence":"additional","affiliation":[{"name":"Superspine, Melbourne, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephanie","family":"Attwell","sequence":"additional","affiliation":[{"name":"Department of Health Professions, Macquarie University, Sydney, New South Wales, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark","family":"Hancock","sequence":"additional","affiliation":[{"name":"Department of Health Professions, Macquarie University, Sydney, New South Wales, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2019,8,18]]},"reference":[{"key":"2025121408400110000_9.8.e031133.1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2013-204428"},{"key":"2025121408400110000_9.8.e031133.2","doi-asserted-by":"crossref","unstructured":"Kongsted A , Kent P , Axen I , et al . 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