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...
| Main Authors: | , , , , , , , , , , , , , |
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| Format: | Journal Article |
| Language: | English |
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BMJ PUBLISHING GROUP
2019
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| Online Access: | http://purl.org/au-research/grants/nhmrc/1145271 http://hdl.handle.net/20.500.11937/93041 |
| _version_ | 1848765689272205312 |
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| author | Kent, Peter O'Sullivan, Peter Smith, Anne Haines, T. Campbell, Amity McGregor, A.H. Hartvigsen, J. O'Sullivan, K. Vickery, A. Caneiro, JP Schütze, Robert Laird, R.A. Attwell, S. Hancock, M. |
| author_facet | Kent, Peter O'Sullivan, Peter Smith, Anne Haines, T. Campbell, Amity McGregor, A.H. Hartvigsen, J. O'Sullivan, K. Vickery, A. Caneiro, JP Schütze, Robert Laird, R.A. Attwell, S. Hancock, M. |
| author_sort | Kent, Peter |
| building | Curtin Institutional Repository |
| collection | Online Access |
| 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 â ? 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. |
| first_indexed | 2025-11-14T11:39:14Z |
| format | Journal Article |
| id | curtin-20.500.11937-93041 |
| institution | Curtin University Malaysia |
| institution_category | Local University |
| language | English |
| last_indexed | 2025-11-14T11:39:14Z |
| publishDate | 2019 |
| publisher | BMJ PUBLISHING GROUP |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | curtin-20.500.11937-930412023-09-19T02:24:19Z 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 Kent, Peter O'Sullivan, Peter Smith, Anne Haines, T. Campbell, Amity McGregor, A.H. Hartvigsen, J. O'Sullivan, K. Vickery, A. Caneiro, JP Schütze, Robert Laird, R.A. Attwell, S. Hancock, M. Science & Technology Life Sciences & Biomedicine Medicine, General & Internal General & Internal Medicine clinical trial protocol low back pain rehabilitation wearable electronic devices GLOBAL BURDEN QUESTIONNAIRE DISABILITY INJURY SCALE REHABILITATION COMMUNICATION VALIDATION MANAGEMENT DISEASE clinical trial protocol low back pain rehabilitation wearable electronic devices Australia Biofeedback, Psychology Chronic Pain Cognitive Behavioral Therapy Cost-Benefit Analysis Disability Evaluation Exercise Humans Low Back Pain Movement Multicenter Studies as Topic Pain Measurement Physical Therapy Modalities Quality-Adjusted Life Years Randomized Controlled Trials as Topic Recovery of Function Transducers Treatment Outcome Humans Low Back Pain Pain Measurement Disability Evaluation Treatment Outcome Exercise Transducers Recovery of Function Movement Quality-Adjusted Life Years Cost-Benefit Analysis Australia Physical Therapy Modalities Multicenter Studies as Topic Randomized Controlled Trials as Topic Biofeedback, Psychology Chronic Pain Cognitive Behavioral Therapy 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 â ? 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. 2019 Journal Article http://hdl.handle.net/20.500.11937/93041 10.1136/bmjopen-2019-031133 English http://purl.org/au-research/grants/nhmrc/1145271 http://creativecommons.org/licenses/by-nc/4.0/ BMJ PUBLISHING GROUP fulltext |
| spellingShingle | Science & Technology Life Sciences & Biomedicine Medicine, General & Internal General & Internal Medicine clinical trial protocol low back pain rehabilitation wearable electronic devices GLOBAL BURDEN QUESTIONNAIRE DISABILITY INJURY SCALE REHABILITATION COMMUNICATION VALIDATION MANAGEMENT DISEASE clinical trial protocol low back pain rehabilitation wearable electronic devices Australia Biofeedback, Psychology Chronic Pain Cognitive Behavioral Therapy Cost-Benefit Analysis Disability Evaluation Exercise Humans Low Back Pain Movement Multicenter Studies as Topic Pain Measurement Physical Therapy Modalities Quality-Adjusted Life Years Randomized Controlled Trials as Topic Recovery of Function Transducers Treatment Outcome Humans Low Back Pain Pain Measurement Disability Evaluation Treatment Outcome Exercise Transducers Recovery of Function Movement Quality-Adjusted Life Years Cost-Benefit Analysis Australia Physical Therapy Modalities Multicenter Studies as Topic Randomized Controlled Trials as Topic Biofeedback, Psychology Chronic Pain Cognitive Behavioral Therapy Kent, Peter O'Sullivan, Peter Smith, Anne Haines, T. Campbell, Amity McGregor, A.H. Hartvigsen, J. O'Sullivan, K. Vickery, A. Caneiro, JP Schütze, Robert Laird, R.A. Attwell, S. Hancock, M. 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 | 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 |
| topic | Science & Technology Life Sciences & Biomedicine Medicine, General & Internal General & Internal Medicine clinical trial protocol low back pain rehabilitation wearable electronic devices GLOBAL BURDEN QUESTIONNAIRE DISABILITY INJURY SCALE REHABILITATION COMMUNICATION VALIDATION MANAGEMENT DISEASE clinical trial protocol low back pain rehabilitation wearable electronic devices Australia Biofeedback, Psychology Chronic Pain Cognitive Behavioral Therapy Cost-Benefit Analysis Disability Evaluation Exercise Humans Low Back Pain Movement Multicenter Studies as Topic Pain Measurement Physical Therapy Modalities Quality-Adjusted Life Years Randomized Controlled Trials as Topic Recovery of Function Transducers Treatment Outcome Humans Low Back Pain Pain Measurement Disability Evaluation Treatment Outcome Exercise Transducers Recovery of Function Movement Quality-Adjusted Life Years Cost-Benefit Analysis Australia Physical Therapy Modalities Multicenter Studies as Topic Randomized Controlled Trials as Topic Biofeedback, Psychology Chronic Pain Cognitive Behavioral Therapy |
| url | http://purl.org/au-research/grants/nhmrc/1145271 http://hdl.handle.net/20.500.11937/93041 |