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 su...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2020-08-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/8/e040543.full |
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| author | Beth Stuart Paul Little Lucy Yardley Stephanie Hughes Adam W A Geraghty Elaine Hay Gemma Mansell Nadine E Foster Jonathan Hill Gareth Griffiths Frances Webley Lorraine Durcan Alannah Morgan Sarah Bathers Stephanie Butler-Walley Simon Wathall Linda Leigh |
| author_facet | Beth Stuart Paul Little Lucy Yardley Stephanie Hughes Adam W A Geraghty Elaine Hay Gemma Mansell Nadine E Foster Jonathan Hill Gareth Griffiths Frances Webley Lorraine Durcan Alannah Morgan Sarah Bathers Stephanie Butler-Walley Simon Wathall Linda Leigh |
| author_sort | Beth Stuart |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-d0724a1af44d401a8e084bb9287037e0 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-08-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-d0724a1af44d401a8e084bb9287037e02024-12-02T12:40:10ZengBMJ Publishing GroupBMJ Open2044-60552020-08-0110810.1136/bmjopen-2020-040543Supporting 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)Beth Stuart0Paul Little1Lucy Yardley2Stephanie Hughes3Adam W A Geraghty4Elaine Hay5Gemma Mansell6Nadine E Foster7Jonathan Hill8Gareth Griffiths9Frances Webley10Lorraine Durcan11Alannah Morgan12Sarah Bathers13Stephanie Butler-Walley14Simon Wathall15Linda Leigh162 Queen Mary University of London, London, UKPrimary Care Research Centre, University of Southampton Faculty of Medicine, Southampton, UKBristol Medical School, University of Bristol, Bristol, UKPrimary Care, Population Sciences and Medical Education, University of Southampton, Southampton, Hampshire, UKSchool of Primary Care, Population Sciences and Medical Education, Faculty of Medicine, University of Southampton, Southampton, UKPrimary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, UKSchool of Life and Health Sciences, Aston University, Birmingham, UKSTARS Education and Research Alliance, The University of Queensland and Metro North Health, Brisbane, Queensland, AustraliaSchool of Psychology and Clinical Language Sciences, University of Reading, Reading, UK3 Southampton Clinical Trials Unit, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UKSchool of Life and Health Sciences, Aston University, Birmingham, UKSchool of Life and Health Sciences, Aston University, Birmingham, UKSchool of Life and Health Sciences, Aston University, Birmingham, UKKeele Clinical Trials Unit, Keele University, Keele, Staffordshire, UKKeele Clinical Trials Unit, Keele University, Keele, Staffordshire, UKInstitute of Primary Care and Health Sciences, Keele University, Staffordshire, UKPatient and Public Involvement Representative, University of Southampton, Southampton, UKIntroduction 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.https://bmjopen.bmj.com/content/10/8/e040543.full |
| spellingShingle | Beth Stuart Paul Little Lucy Yardley Stephanie Hughes Adam W A Geraghty Elaine Hay Gemma Mansell Nadine E Foster Jonathan Hill Gareth Griffiths Frances Webley Lorraine Durcan Alannah Morgan Sarah Bathers Stephanie Butler-Walley Simon Wathall Linda Leigh 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 |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/10/8/e040543.full |
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