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RESTORE-Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain: study protocol for a randomised controlled trial.
BMJ Open. 2019 08 18; 9(8):e031133.BO

Abstract

INTRODUCTION

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.

METHODS AND ANALYSIS

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 >3 months; sought primary care ≥6 weeks ago for this episode of LBP; average LBP intensity of ≥4 (0-10 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 'booster' 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 .

ETHICS AND DISSEMINATION

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.

TRIAL REGISTRATION NUMBER

Australian New Zealand Clinical Trials Registry (ACTRN12618001396213).

Authors+Show Affiliations

School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia peter.kent@curtin.edu.au. Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.Faculty of Medicine, Nursing and Health Science, Monash University, Melbourne, Victoria, Australia.School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.Department of Surgery and Cancer, Imperial College London, London, UK.Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark. Nordic Institute of Chiropractic and Clinical Biomechanics, Odense, Denmark.Sports Spine Centre, Aspetar Qatar Orthopaedic and Sports Medicine Hospital, Doha, Qatar.General Practice, The University of Western Australia, Crawley, Western Australia, Australia.School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.Superspine, Melbourne, Victoria, Australia.Department of Health Professions, Macquarie University, Sydney, New South Wales, Australia.Department of Health Professions, Macquarie University, Sydney, New South Wales, Australia.

Pub Type(s)

Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

31427344

Citation

Kent, Peter, et al. "RESTORE-Cognitive Functional Therapy With or Without Movement Sensor Biofeedback Versus Usual Care for Chronic, Disabling Low Back Pain: Study Protocol for a Randomised Controlled Trial." BMJ Open, vol. 9, no. 8, 2019, pp. e031133.
Kent P, O'Sullivan P, Smith A, et al. RESTORE-Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain: study protocol for a randomised controlled trial. BMJ Open. 2019;9(8):e031133.
Kent, P., O'Sullivan, P., Smith, A., Haines, T., Campbell, A., McGregor, A. H., Hartvigsen, J., O'Sullivan, K., Vickery, A., Caneiro, J. P., Schütze, R., Laird, R. A., Attwell, S., & Hancock, M. (2019). RESTORE-Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain: study protocol for a randomised controlled trial. BMJ Open, 9(8), e031133. https://doi.org/10.1136/bmjopen-2019-031133
Kent P, et al. RESTORE-Cognitive Functional Therapy With or Without Movement Sensor Biofeedback Versus Usual Care for Chronic, Disabling Low Back Pain: Study Protocol for a Randomised Controlled Trial. BMJ Open. 2019 08 18;9(8):e031133. PubMed PMID: 31427344.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - RESTORE-Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain: study protocol for a randomised controlled trial. AU - Kent,Peter, AU - O'Sullivan,P, AU - Smith,Anne,Dr AU - Haines,Terry, AU - Campbell,Amity, AU - McGregor,Alison H, AU - Hartvigsen,Jan, AU - O'Sullivan,Kieran, AU - Vickery,Alistair, AU - Caneiro,J P, AU - Schütze,Robert, AU - Laird,Robert A, AU - Attwell,Stephanie, AU - Hancock,Mark, Y1 - 2019/08/18/ PY - 2019/8/21/entrez PY - 2019/8/21/pubmed PY - 2020/9/15/medline KW - clinical trial protocol KW - low back pain KW - rehabilitation KW - wearable electronic devices SP - e031133 EP - e031133 JF - BMJ open JO - BMJ Open VL - 9 IS - 8 N2 - INTRODUCTION: 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. METHODS AND ANALYSIS: 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 >3 months; sought primary care ≥6 weeks ago for this episode of LBP; average LBP intensity of ≥4 (0-10 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 'booster' 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 . ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12618001396213). SN - 2044-6055 UR - https://www.unboundmedicine.com/medline/citation/31427344/RESTORE_Cognitive_functional_therapy_with_or_without_movement_sensor_biofeedback_versus_usual_care_for_chronic_disabling_low_back_pain:_study_protocol_for_a_randomised_controlled_trial_ L2 - http://bmjopen.bmj.com/cgi/pmidlookup?view=long&pmid=31427344 DB - PRIME DP - Unbound Medicine ER -