{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T03:58:02Z","timestamp":1788926282987,"version":"build-2803163510"},"reference-count":97,"publisher":"BMJ","issue":"7","license":[{"start":{"date-parts":[[2025,8,1]],"date-time":"2025-08-01T00:00:00Z","timestamp":1754006400000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Rewarding Research Success Funding Scheme, Faculty of Medicine and Health, The University of Sydney","award":["Grant ID: G216248, PC: RX450"],"award-info":[{"award-number":["Grant ID: G216248, PC: RX450"]}]},{"name":"Research Training Program Scholarship (RTP), Australian Government"},{"name":"Leadership Fellowship, National Health and Medical Research Council of Australia"},{"name":"Sir Randal Heymanson Fellowship, University of Melbourne"},{"name":"Faculty of Medicine and Health Research Centres Stipend Scholarship, The University of Sydney"},{"name":"International Tuition Fee Scholarship, The University of Sydney"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,7,3]]},"published-print":{"date-parts":[[2025,8]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>As chronic low back pain (LBP) remains one of the most pressing global health challenges, digital health emerges as an opportunity to deliver evidence-based care at scale. In this context, the My Back Exercise app has been developed to support people with LBP in self-managing their condition. This study aims to determine the effectiveness of the My Back Exercise app to improve physical function in people with chronic non-specific LBP.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>A single-blind, superiority, adaptive randomised controlled trial encompassing a multi-arm multi-stage design will be conducted and reported according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT), Template for the Intervention Description and Replication for telehealth (TIDieR-telehealth), and the Consolidated Standards of Reporting Trials (CONSORT) Extension for Adaptive Designs. Informed consent will be obtained from all participants. Eligible participants will be randomly assigned in a 1:1:1:1:1 ratio to either the control group, receiving education alone, or one of four intervention groups ((1) education, notifications and exercise modules; (2) education, notifications, exercise and sleep modules; (3) education, notifications, exercise and diet modules; and (4) education, notifications, exercise, sleep and diet modules) through the app. The study consists of two stages with the possibility of dropping arms for futility using pre-specified decision rules at the end of the first stage. A total of 370 participants aged 18 years or older, with chronic non-specific LBP, will be recruited Australia-wide from the general community. The primary outcome will be self-reported physical function measured by the Patient-Specific Functional Scale at 6 weeks post-randomisation. Data will be analysed using the Student\u2019s t-test or the non-parametric Mann-Whitney U test.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>This trial was approved by the Human Research Ethics Committee (HREC) of The University of Sydney (HREC Approval No. 2023\/HE000772). The findings of this study will be disseminated via scientific publications, reports and conference presentations, and strategically disseminated to the wider community and relevant policymakers.<\/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 (ACTRN12624000319572).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2024-098324","type":"journal-article","created":{"date-parts":[[2025,8,1]],"date-time":"2025-08-01T09:01:24Z","timestamp":1754038884000},"page":"e098324","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"title":["My Back Exercise app: an automated exercise intervention supported by educational notifications, a sleep programme and diet advice to improve function in people with chronic non-specific low back pain \u2013 protocol for a superiority, adaptive multi-arm multi-stage randomised controlled trial"],"prefix":"10.1136","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2179-3620","authenticated-orcid":false,"given":"Anelise Moreti Cabral","family":"Silveira","sequence":"first","affiliation":[{"name":"Faculty of Medicine and Health, Sydney Musculoskeletal Health, The University of Sydney, Sydney, New South Wales, Australia"},{"name":"Musculoskeletal Research Hub, Charles Perkins Centre, The University of Sydney, Sydney, New South Wales, Australia"},{"name":"The George Institute for Global Health, UNSW Sydney, Sydney, New South Wales, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3286-6998","authenticated-orcid":false,"given":"Josielli","family":"Comachio","sequence":"additional","affiliation":[{"name":"Faculty of Medicine and Health, Sydney Musculoskeletal Health, The University of Sydney, Sydney, New South Wales, 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