Supporting self-management of low back pain with an internet intervention with and without telephone support in primary care (SupportBack 2): a randomised controlled trial of clinical and cost-effectiveness

Abstract

Background: Low back pain is prevalent and a leading cause of disability. We aimed to determine the clinical and cost-effectiveness of an accessible, scalable internet intervention for supporting behavioural self-management (SupportBack). Methods: Participants in UK primary care with low back pain without serious spinal pathology were randomly assigned 1:1:1 using computer algorithms stratified by disability level and telephone-support centre to usual care, usual care and SupportBack, or usual care and SupportBack with physiotherapist telephone-support (three brief calls). The primary outcome was low back pain-related disability (Roland Morris Disability Questionnaire [RMDQ] score) at 6 weeks, 3 months, 6 months, and 12 months using a repeated measures model, analysed by intention to treat using 97·5% CIs. A parallel economic evaluation from a health services perspective was used to estimate cost-effectiveness. People with lived experience of low back pain were involved in this trial from the outset. This completed trial was registered with ISRCTN, ISRCTN14736486. Findings: Between Nov 29, 2018, and Jan 12, 2021, 825 participants were randomly assigned (274 to usual care, 275 to SupportBack only, 276 to SupportBack with telephone-support). Participants had a mean age of 54 (SD 15), 479 (58%) of 821 were women and 342 (42%) were men, and 591 (92%) of 641 were White. Follow-up rates were 687 (83%) at 6 weeks, 598 (73%) at 3 months, 589 (72%) at 6 months, and 652 (79%) at 12 months. For the primary analysis, 736 participants were analysed (249 usual care, 245 SupportBack, and 242 SupportBack with telephone support). At a significance level of 0·025, there was no difference in RMDQ over 12 months with SupportBack versus usual care (adjusted mean difference –0·5 [97·5% CI –1·2 to 0·2]; p=0·085) or SupportBack with telephone-support versus usual care (–0·6 [–1·2 to 0·1]; p=0·048). There were no treatment-related serious adverse events. The economic evaluation showed that the SupportBack group dominated usual care, being both more effective and less costly. Both interventions were likely to be cost-effective at a threshold of £20 000 per quality adjusted life year compared with usual care. Interpretation: The SupportBack internet interventions did not significantly reduce low back pain-related disability over 12 months compared with usual care. They were likely to be cost-effective and safe. Clinical effectiveness, cost-effectiveness, and safety should be considered together when determining whether to apply these interventions in clinical practice. Funding: National Institute for Health and Care Research Health Technology Assessment (16/111/78).

Publication DOI: https://doi.org/10.1016/s2665-9913(24)00086-9
Divisions: College of Health & Life Sciences
College of Health & Life Sciences > School of Psychology
Aston University (General)
Funding Information: National Institute for Health and Care Research Health Technology Assessment (16/111/78).
Additional Information: Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license.
Uncontrolled Keywords: Rheumatology,Immunology and Allergy,Immunology
Publication ISSN: 2665-9913
Data Access Statement: Individual participant data will be made available, including data dictionaries, for approved data sharing requests. Individual participant data will be shared that underlie the results reported in this article, after deidentification and normalisation of information (text, tables, figures, and appendices). Anonymised data will be available beginning 3 months after and ending 10 years after publication of this article to researchers who provide a completed Data Sharing Agreement that describes a<br/>methodologically sound proposal for the purpose of the approved proposal. Proposals should be directed to ctu@soton.ac.uk. Data will be shared once all relevant parties approve and sign the Data Sharing Agreement. Data sharing requests are available for 10 years via the Southampton Clinical Trials Unit website.
Last Modified: 02 Dec 2024 09:08
Date Deposited: 30 Oct 2024 16:05
Full Text Link:
Related URLs: https://www.sco ... tnerID=8YFLogxK (Scopus URL)
https://www.the ... 0086-9/fulltext (Publisher URL)
PURE Output Type: Article
Published Date: 2024-07
Published Online Date: 2024-05-30
Accepted Date: 2024-05-01
Authors: Geraghty, Adam W.A.
Becque, Taeko
Roberts, Lisa C.
Hill, Jonathan C.
Foster, Nadine E.
Yardley, Lucy
Stuart, Beth
Turner, David A.
Hay, Elaine
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)
White, Malcolm
Davies, Firoza
Little, Paul

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