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)

Geraghty, Adam, Roberts, Lisa C., Hill, Jonathan C., Foster, Nadine E., Yardley, Lucy, Hay, Elaine M., 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. ISSN 2044-6055 (In Press)

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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 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

Item Type: Article
Faculty \ School: Faculty of Medicine and Health Sciences > Norwich Medical School
Depositing User: LivePure Connector
Date Deposited: 11 Jun 2020 01:29
Last Modified: 01 Aug 2020 23:48
URI: https://ueaeprints.uea.ac.uk/id/eprint/75556
DOI:

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