Supporting self-management of low back pain with an internet intervention in primary care: a protocol for a randomised controlled trial of clinical and cost-effectiveness (SupportBack 2)

Adam W A Geraghty; Lisa Roberts; Jonathan Hill; Nadine E Foster; Lucy Yardley; Elaine Hay; Beth Stuart; David Turner; Gareth Griffiths; Frances Webley; Lorraine Durcan; Alannah Morgan; Stephanie Hughes; Sarah Bathers; Stephanie Butler-Walley; Simon Wathall; Gemma Mansell; Linda Leigh; Paul Little

doi:10.1136/bmjopen-2020-040543

Supporting self-management of low back pain with an internet intervention in primary care: a protocol for a randomised controlled trial of clinical and cost-effectiveness (SupportBack 2)

Adam W A Geraghty^*, Lisa Roberts, Jonathan Hill, Nadine E Foster, Lucy Yardley, Elaine Hay, Beth Stuart, David Turner, Gareth Griffiths, Frances Webley, Lorraine Durcan, Alannah Morgan, Stephanie Hughes, Sarah Bathers, Stephanie Butler-Walley, Simon Wathall, Gemma Mansell, Linda Leigh, Paul Little

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

Abstract

Introduction: Self-management and remaining physically active are first-line recommendations for the care of patients with low back pain (LBP). With a lifetime prevalence of up to 85%, novel approaches to support behavioural self-management are needed. Internet interventions may provide accessible support for self-management of LBP in primary care. The aim of this randomised controlled trial is to determine the clinical and cost-effectiveness of the ‘SupportBack’ internet intervention, with or without physiotherapist telephone support in reducing LBP-related disability in primary care patients. Methods and analysis: A three-parallel arm, multicentre randomised controlled trial will compare three arms: (1) usual primary care for LBP; (2) usual primary care for LBP and an internet intervention; (3) usual primary care for LBP and an internet intervention with additional physiotherapist telephone support. Patients with current LBP and no indicators of serious spinal pathology are identified and invited via general practice list searches and mailouts or opportunistic recruitment following LBP consultations. Participants undergo a secondary screen for possible serious spinal pathology and are then asked to complete baseline measures online after which they are randomised to an intervention arm. Follow-ups occur at 6 weeks, 3, 6 and 12 months. The primary outcome is physical function (using the Roland and Morris Disability Questionnaire) over 12 months (repeated measures design). Secondary outcomes include pain intensity, troublesome days in pain over the last month, pain self-efficacy, catastrophising, kinesophobia, health-related quality of life and cost-related measures for a full health economic analysis. A full mixed-methods process evaluation will be conducted. Ethics and dissemination: This trial has been approved by a National Health Service Research Ethics Committee (REC Ref: 18/SC/0388). Results will be disseminated through peer-reviewed journals, conferences, communication with practices and patient groups. Patient representatives will support the implementation of our full dissemination strategy. Trial registration number: ISRCTN14736486.

Original language	English
Article number	e040543
Journal	BMJ Open
Volume	10
Issue number	8
DOIs	https://doi.org/10.1136/bmjopen-2020-040543
Publication status	Published - 20 Aug 2020

Bibliographical note

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/
This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

Keywords

back pain
primary care
rehabilitation medicine

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Geraghty, A. W. A., Roberts, L., Hill, J., Foster, N. E., Yardley, L., Hay, E., Stuart, B., Turner, D., Griffiths, G., Webley, F., Durcan, L., Morgan, A., Hughes, S., Bathers, S., Butler-Walley, S., Wathall, S., Mansell, G., Leigh, L., & Little, P. (2020). Supporting self-management of low back pain with an internet intervention in primary care: a protocol for a randomised controlled trial of clinical and cost-effectiveness (SupportBack 2). BMJ Open, 10(8), Article e040543. https://doi.org/10.1136/bmjopen-2020-040543

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abstract = "Introduction: Self-management and remaining physically active are first-line recommendations for the care of patients with low back pain (LBP). With a lifetime prevalence of up to 85%, novel approaches to support behavioural self-management are needed. Internet interventions may provide accessible support for self-management of LBP in primary care. The aim of this randomised controlled trial is to determine the clinical and cost-effectiveness of the {\textquoteleft}SupportBack{\textquoteright} internet intervention, with or without physiotherapist telephone support in reducing LBP-related disability in primary care patients. Methods and analysis: A three-parallel arm, multicentre randomised controlled trial will compare three arms: (1) usual primary care for LBP; (2) usual primary care for LBP and an internet intervention; (3) usual primary care for LBP and an internet intervention with additional physiotherapist telephone support. Patients with current LBP and no indicators of serious spinal pathology are identified and invited via general practice list searches and mailouts or opportunistic recruitment following LBP consultations. Participants undergo a secondary screen for possible serious spinal pathology and are then asked to complete baseline measures online after which they are randomised to an intervention arm. Follow-ups occur at 6 weeks, 3, 6 and 12 months. The primary outcome is physical function (using the Roland and Morris Disability Questionnaire) over 12 months (repeated measures design). Secondary outcomes include pain intensity, troublesome days in pain over the last month, pain self-efficacy, catastrophising, kinesophobia, health-related quality of life and cost-related measures for a full health economic analysis. A full mixed-methods process evaluation will be conducted. Ethics and dissemination: This trial has been approved by a National Health Service Research Ethics Committee (REC Ref: 18/SC/0388). Results will be disseminated through peer-reviewed journals, conferences, communication with practices and patient groups. Patient representatives will support the implementation of our full dissemination strategy. Trial registration number: ISRCTN14736486.",

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author = "Geraghty, {Adam W A} and Lisa Roberts and Jonathan Hill and Foster, {Nadine E} and Lucy Yardley and Elaine Hay and Beth Stuart and David Turner and Gareth Griffiths and Frances Webley and Lorraine Durcan and Alannah Morgan and Stephanie Hughes and Sarah Bathers and Stephanie Butler-Walley and Simon Wathall and Gemma Mansell and Linda Leigh and Paul Little",

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Geraghty, AWA, Roberts, L, Hill, J, Foster, NE, Yardley, L, Hay, E, Stuart, B, Turner, D, Griffiths, G, Webley, F, Durcan, L, Morgan, A, Hughes, S, Bathers, S, Butler-Walley, S, Wathall, S, Mansell, G, Leigh, L & Little, P 2020, 'Supporting self-management of low back pain with an internet intervention in primary care: a protocol for a randomised controlled trial of clinical and cost-effectiveness (SupportBack 2)', BMJ Open, vol. 10, no. 8, e040543. https://doi.org/10.1136/bmjopen-2020-040543

TY - JOUR

T1 - Supporting self-management of low back pain with an internet intervention in primary care: a protocol for a randomised controlled trial of clinical and cost-effectiveness (SupportBack 2)

AU - Geraghty, Adam W A

AU - Roberts, Lisa

AU - Hill, Jonathan

AU - Foster, Nadine E

AU - Yardley, Lucy

AU - Hay, Elaine

AU - Stuart, Beth

AU - Turner, David

AU - Griffiths, Gareth

AU - Webley, Frances

AU - Durcan, Lorraine

AU - Morgan, Alannah

AU - Hughes, Stephanie

AU - Bathers, Sarah

AU - Butler-Walley, Stephanie

AU - Wathall, Simon

AU - Mansell, Gemma

AU - Leigh, Linda

AU - Little, Paul

N1 - © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

PY - 2020/8/20

Y1 - 2020/8/20

N2 - Introduction: Self-management and remaining physically active are first-line recommendations for the care of patients with low back pain (LBP). With a lifetime prevalence of up to 85%, novel approaches to support behavioural self-management are needed. Internet interventions may provide accessible support for self-management of LBP in primary care. The aim of this randomised controlled trial is to determine the clinical and cost-effectiveness of the ‘SupportBack’ internet intervention, with or without physiotherapist telephone support in reducing LBP-related disability in primary care patients. Methods and analysis: A three-parallel arm, multicentre randomised controlled trial will compare three arms: (1) usual primary care for LBP; (2) usual primary care for LBP and an internet intervention; (3) usual primary care for LBP and an internet intervention with additional physiotherapist telephone support. Patients with current LBP and no indicators of serious spinal pathology are identified and invited via general practice list searches and mailouts or opportunistic recruitment following LBP consultations. Participants undergo a secondary screen for possible serious spinal pathology and are then asked to complete baseline measures online after which they are randomised to an intervention arm. Follow-ups occur at 6 weeks, 3, 6 and 12 months. The primary outcome is physical function (using the Roland and Morris Disability Questionnaire) over 12 months (repeated measures design). Secondary outcomes include pain intensity, troublesome days in pain over the last month, pain self-efficacy, catastrophising, kinesophobia, health-related quality of life and cost-related measures for a full health economic analysis. A full mixed-methods process evaluation will be conducted. Ethics and dissemination: This trial has been approved by a National Health Service Research Ethics Committee (REC Ref: 18/SC/0388). Results will be disseminated through peer-reviewed journals, conferences, communication with practices and patient groups. Patient representatives will support the implementation of our full dissemination strategy. Trial registration number: ISRCTN14736486.

AB - Introduction: Self-management and remaining physically active are first-line recommendations for the care of patients with low back pain (LBP). With a lifetime prevalence of up to 85%, novel approaches to support behavioural self-management are needed. Internet interventions may provide accessible support for self-management of LBP in primary care. The aim of this randomised controlled trial is to determine the clinical and cost-effectiveness of the ‘SupportBack’ internet intervention, with or without physiotherapist telephone support in reducing LBP-related disability in primary care patients. Methods and analysis: A three-parallel arm, multicentre randomised controlled trial will compare three arms: (1) usual primary care for LBP; (2) usual primary care for LBP and an internet intervention; (3) usual primary care for LBP and an internet intervention with additional physiotherapist telephone support. Patients with current LBP and no indicators of serious spinal pathology are identified and invited via general practice list searches and mailouts or opportunistic recruitment following LBP consultations. Participants undergo a secondary screen for possible serious spinal pathology and are then asked to complete baseline measures online after which they are randomised to an intervention arm. Follow-ups occur at 6 weeks, 3, 6 and 12 months. The primary outcome is physical function (using the Roland and Morris Disability Questionnaire) over 12 months (repeated measures design). Secondary outcomes include pain intensity, troublesome days in pain over the last month, pain self-efficacy, catastrophising, kinesophobia, health-related quality of life and cost-related measures for a full health economic analysis. A full mixed-methods process evaluation will be conducted. Ethics and dissemination: This trial has been approved by a National Health Service Research Ethics Committee (REC Ref: 18/SC/0388). Results will be disseminated through peer-reviewed journals, conferences, communication with practices and patient groups. Patient representatives will support the implementation of our full dissemination strategy. Trial registration number: ISRCTN14736486.

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KW - primary care

KW - rehabilitation medicine

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U2 - 10.1136/bmjopen-2020-040543

DO - 10.1136/bmjopen-2020-040543

M3 - Article

SN - 2044-6055

VL - 10

JO - BMJ Open

JF - BMJ Open

IS - 8

M1 - e040543

ER -

Supporting self-management of low back pain with an internet intervention in primary care: a protocol for a randomised controlled trial of clinical and cost-effectiveness (SupportBack 2)

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Keywords

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