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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 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.

Cost-Benefit Analysis, Humans, Internet, Internet-Based Intervention, Low Back Pain/therapy, Multicenter Studies as Topic, Primary Health Care, Quality of Life, Randomized Controlled Trials as Topic, Self-Management, State Medicine
2044-6055
e040543
Geraghty, Adam W A
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Roberts, Lisa
0a937943-5246-4877-bd6b-4dcd172b5cd0
Hill, Jonathan
8e544af1-9ac0-46d3-9821-2c0014a61a85
Foster, Nadine E
2ca79c15-6ada-4b99-982c-f8abee19e628
Yardley, Lucy
64be42c4-511d-484d-abaa-f8813452a22e
Hay, Elaine
9fdd04be-2a91-4b9c-8524-37a6111fdf9c
Stuart, Beth
626862fc-892b-4f6d-9cbb-7a8d7172b209
Turner, David
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Griffiths, Gareth
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Webley, Frances
143f965b-866b-4455-89a5-d187f52e1cde
Durcan, Lorraine
bd059b41-9e77-4afe-b271-9ac4c91a05c6
Morgan, Alannah
8153a571-1d92-4466-a992-24e7d0e1c2ec
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
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Geraghty, Adam W A
2c6549fe-9868-4806-b65a-21881c1930af
Roberts, Lisa
0a937943-5246-4877-bd6b-4dcd172b5cd0
Hill, Jonathan
8e544af1-9ac0-46d3-9821-2c0014a61a85
Foster, Nadine E
2ca79c15-6ada-4b99-982c-f8abee19e628
Yardley, Lucy
64be42c4-511d-484d-abaa-f8813452a22e
Hay, Elaine
9fdd04be-2a91-4b9c-8524-37a6111fdf9c
Stuart, Beth
626862fc-892b-4f6d-9cbb-7a8d7172b209
Turner, David
407ea6bc-44cc-4afd-927d-ea953190e60a
Griffiths, Gareth
7fd300c0-d279-4ff6-842d-aa1f2b9b864d
Webley, Frances
143f965b-866b-4455-89a5-d187f52e1cde
Durcan, Lorraine
bd059b41-9e77-4afe-b271-9ac4c91a05c6
Morgan, Alannah
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Hughes, Stephanie
05f3a01e-73a1-4b1d-9996-a0028c42ec2e
Bathers, Sarah
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Butler-Walley, Stephanie
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Wathall, Simon
c42a8959-f437-4fde-80a7-a6f080cc9f18
Mansell, Gemma
be6d92d7-996f-49a2-b598-d3be41a1b6d5
Leigh, Linda
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Little, Paul
1bf2d1f7-200c-47a5-ab16-fe5a8756a777

Geraghty, Adam W A, 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, [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 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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More information

Accepted/In Press date: 5 June 2020
e-pub ahead of print date: 20 August 2020
Published date: 20 August 2020
Additional Information: © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.
Keywords: Cost-Benefit Analysis, Humans, Internet, Internet-Based Intervention, Low Back Pain/therapy, Multicenter Studies as Topic, Primary Health Care, Quality of Life, Randomized Controlled Trials as Topic, Self-Management, State 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 W A 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: 06 Jun 2024 01:53

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Contributors

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: Stephanie Hughes
Author: Sarah Bathers
Author: Stephanie Butler-Walley
Author: Simon Wathall
Author: Gemma Mansell
Author: Linda Leigh
Author: Paul Little

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