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)

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.

Publication DOI: https://doi.org/10.1136/bmjopen-2020-040543
Divisions: College of Health & Life Sciences > School of Psychology
College of Health & Life Sciences > Applied Health Research Group
College of Health & Life Sciences
Additional Information: © 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/.
Uncontrolled Keywords: back pain,primary care,rehabilitation medicine,Medicine(all)
Full Text Link:
Related URLs: https://bmjopen ... nt/10/8/e040543 (Publisher URL)
http://www.scop ... tnerID=8YFLogxK (Scopus URL)
PURE Output Type: Article
Published Date: 2020-08-20
Accepted Date: 2020-06-05
Authors: 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 (ORCID Profile 0000-0002-5479-2678)
Leigh, Linda
Little, Paul

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