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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)

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)
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)
Introduction
Self-management and remaining physically active are first-line recommendations for the care of patients with low back pain (LBP). With a life-time 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, multi-centre 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 six weeks, three, six 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 an NHS 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: ISRCTN reference 14736486 (pre-results)
Key words: Low Back Pain; Internet Intervention; Primary Care; Randomised Controlled Trial

back pain, primary care, rehabilitation medicine
2044-6055
Geraghty, Adam
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Roberts, Lisa
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Hill, Jonathan
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Foster, Nadine E.
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Yardley, Lucy
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Hay, Elaine
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Stuart, Beth
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Turner, David
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Griffiths, Gareth
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Webley, Frances
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Durcan, Lorraine
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Morgan, Alannah
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Hughes, Stephanie
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Bathers, Sarah
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Butler-Walley, Stephanie
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Wathall, Simon
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Mansell, Gemma
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Leigh, Linda
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Little, Paul
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Geraghty, Adam
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Roberts, Lisa
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Hill, Jonathan
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Foster, Nadine E.
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Yardley, Lucy
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Hay, Elaine
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Stuart, Beth
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Turner, David
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Griffiths, Gareth
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Webley, Frances
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Durcan, Lorraine
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Morgan, Alannah
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Hughes, Stephanie
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Bathers, Sarah
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Butler-Walley, Stephanie
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Wathall, Simon
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Mansell, Gemma
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Leigh, Linda
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Little, Paul
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Geraghty, Adam, Roberts, Lisa, Hill, Jonathan, Foster, Nadine E., Yardley, Lucy, Hay, Elaine, Stuart, Beth, Turner, David, Griffiths, Gareth, Webley, Frances, Durcan, Lorraine, Morgan, Alannah, Hughes, Stephanie, Bathers, Sarah, Butler-Walley, Stephanie, Wathall, Simon, Mansell, Gemma, Leigh, Linda and Little, Paul (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), [e040543]. (doi:10.1136/bmjopen-2020-040543).

Record type: Article

Abstract

Introduction
Self-management and remaining physically active are first-line recommendations for the care of patients with low back pain (LBP). With a life-time 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, multi-centre 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 six weeks, three, six 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 an NHS 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: ISRCTN reference 14736486 (pre-results)
Key words: Low Back Pain; Internet Intervention; Primary Care; Randomised Controlled Trial

This record has no associated files available for download.

More information

Accepted/In Press date: 5 June 2020
e-pub ahead of print date: 20 August 2020
Published date: September 2020
Keywords: back pain, primary care, rehabilitation medicine

Identifiers

Local EPrints ID: 443846
URI: http://eprints.soton.ac.uk/id/eprint/443846
ISSN: 2044-6055
PURE UUID: 480db76a-e242-43b1-ba3c-16d281b347ec
ORCID for Adam Geraghty: ORCID iD orcid.org/0000-0001-7984-8351
ORCID for Lisa Roberts: ORCID iD orcid.org/0000-0003-2662-6696
ORCID for Lucy Yardley: ORCID iD orcid.org/0000-0002-3853-883X
ORCID for Beth Stuart: ORCID iD orcid.org/0000-0001-5432-7437
ORCID for Gareth Griffiths: ORCID iD orcid.org/0000-0002-9579-8021

Catalogue record

Date deposited: 14 Sep 2020 16:37
Last modified: 10 Jan 2022 03:03

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Contributors

Author: Adam Geraghty ORCID iD
Author: Lisa Roberts ORCID iD
Author: Jonathan Hill
Author: Nadine E. Foster
Author: Lucy Yardley ORCID iD
Author: Elaine Hay
Author: Beth Stuart ORCID iD
Author: David Turner
Author: Frances Webley
Author: Lorraine Durcan
Author: Alannah Morgan
Author: Sarah Bathers
Author: Stephanie Butler-Walley
Author: Simon Wathall
Author: Gemma Mansell
Author: Linda Leigh
Author: Paul Little

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