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
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...
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BMJ Publishing Group
2019-08-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/9/8/e031133.full |
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| author | Alison H McGregor Mark Hancock Peter Kent P O'Sullivan Anne Smith Terry Haines Amity Campbell Jan Hartvigsen Kieran O'Sullivan Alistair Vickery JP Caneiro Robert Schütze Robert A Laird Stephanie Attwell |
| author_facet | Alison H McGregor Mark Hancock Peter Kent P O'Sullivan Anne Smith Terry Haines Amity Campbell Jan Hartvigsen Kieran O'Sullivan Alistair Vickery JP Caneiro Robert Schütze Robert A Laird Stephanie Attwell |
| author_sort | Alison H McGregor |
| collection | DOAJ |
| description | 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). |
| format | Article |
| id | doaj-art-bb44b523f8c944f8b8e9c63eacbe60d2 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-08-01 |
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| series | BMJ Open |
| spelling | doaj-art-bb44b523f8c944f8b8e9c63eacbe60d22024-11-26T17:40:12ZengBMJ Publishing GroupBMJ Open2044-60552019-08-019810.1136/bmjopen-2019-031133RESTORE—Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain: study protocol for a randomised controlled trialAlison H McGregor0Mark Hancock1Peter Kent2P O'Sullivan3Anne Smith4Terry Haines5Amity Campbell6Jan Hartvigsen7Kieran O'Sullivan8Alistair Vickery9JP Caneiro10Robert Schütze11Robert A Laird12Stephanie Attwell13professor of musculoskeletal biodynamicsDepartment of Health Sciences, Faculty of Medicine, Health and Human Sciences, Macquarie University, Sydney, New South Wales, Australia2 Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark1 School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, AustraliaSchool of Allied Health, Curtin University, Perth, Western Australia, AustraliaSchool of Primary and Allied Health Care, Monash University, Melbourne, Victoria, Australia1 School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, AustraliaNordic Institute of Chiropractic and Clinical Biomechanics, Odense, Denmark7 Sports Spine Centre, Aspetar Qatar Orthopaedic and Sports Medicine Hospital, Doha, Qatar7 General Practice, The University of Western Australia, Crawley, Western Australia, Australia2 Body Logic Physiotherapy, Perth, Western Australia, AustraliaSchool of Allied Health, Faculty of Health Sciences, Curtin University, Perth, Western Australia, Australia8 Superspine, Melbourne, Victoria, Australia9 Department of Health Professions, Macquarie University, Sydney, New South Wales, AustraliaIntroduction 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).https://bmjopen.bmj.com/content/9/8/e031133.full |
| spellingShingle | Alison H McGregor Mark Hancock Peter Kent P O'Sullivan Anne Smith Terry Haines Amity Campbell Jan Hartvigsen Kieran O'Sullivan Alistair Vickery JP Caneiro Robert Schütze Robert A Laird Stephanie Attwell 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 |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/9/8/e031133.full |
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