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

Peter Kent, P. O'Sullivan, Anne Smith, Terry Haines, Amity Campbell, Alison H. McGregor, Jan Hartvigsen, Kieran O'Sullivan, Alistair Vickery, J. P. Caneiro, Robert Schütze, Robert A. Laird, Stephanie Attwell, Mark Hancock

Research output: Contribution to journalArticle

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 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.

Original languageEnglish
Article numbere031133
JournalBMJ Open
Volume9
Issue number8
DOIs
Publication statusPublished - 1 Aug 2019

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Cognitive Therapy
Low Back Pain
Randomized Controlled Trials
Economics
Pain
Quality-Adjusted Life Years
Research Ethics Committees
Ethics
Cost-Benefit Analysis
Publications
Biofeedback (Psychology)
Life Style
Linear Models
Primary Health Care
Patient Care
Rehabilitation
Costs and Cost Analysis
Therapeutics
Neoplasms

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Kent, Peter ; O'Sullivan, P. ; Smith, Anne ; Haines, Terry ; Campbell, Amity ; McGregor, Alison H. ; Hartvigsen, Jan ; O'Sullivan, Kieran ; Vickery, Alistair ; Caneiro, J. P. ; Schütze, Robert ; Laird, Robert A. ; Attwell, Stephanie ; Hancock, Mark. / 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. In: BMJ Open. 2019 ; Vol. 9, No. 8.
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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 {\^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.",
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author = "Peter Kent and P. O'Sullivan and Anne Smith and Terry Haines and Amity Campbell and McGregor, {Alison H.} and Jan Hartvigsen and Kieran O'Sullivan and Alistair Vickery and Caneiro, {J. P.} and Robert Sch{\"u}tze and Laird, {Robert A.} and Stephanie Attwell and Mark Hancock",
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Kent, P, O'Sullivan, P, Smith, A, Haines, T, Campbell, A, McGregor, AH, Hartvigsen, J, O'Sullivan, K, Vickery, A, Caneiro, JP, Schütze, R, Laird, RA, 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, vol. 9, no. 8, e031133. https://doi.org/10.1136/bmjopen-2019-031133

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, P.; Smith, Anne; Haines, Terry; Campbell, Amity; McGregor, Alison H.; Hartvigsen, Jan; O'Sullivan, Kieran; Vickery, Alistair; Caneiro, J. P.; Schütze, Robert; Laird, Robert A.; Attwell, Stephanie; Hancock, Mark.

In: BMJ Open, Vol. 9, No. 8, e031133, 01.08.2019.

Research output: Contribution to journalArticle

TY - JOUR

T1 - RESTORE-Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain

T2 - Study protocol for a randomised controlled trial

AU - Kent, Peter

AU - O'Sullivan, P.

AU - Smith, Anne

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

PY - 2019/8/1

Y1 - 2019/8/1

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 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.

AB - 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.

KW - clinical trial protocol

KW - low back pain

KW - rehabilitation

KW - wearable electronic devices

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U2 - 10.1136/bmjopen-2019-031133

DO - 10.1136/bmjopen-2019-031133

M3 - Article

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JO - BMJ (Open)

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