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Geraghty, Adam W. A., Becque, Taeko, Roberts, Lisa C., Hill, Jonathan C., Foster, Nadine E., Yardley, Lucy, Stuart, Beth, Turner, David A. 
ORCID: https://orcid.org/0000-0002-1689-4147, Hay, Elaine, Griffiths, Gareth, Webley, Frances, Durcan, Lorraine, Morgan, Alannah, Hughes, Stephanie, Bathers, Sarah, Butler-Walley, Stephanie, Wathall, Simon, Mansell, Gemma, White, Malcolm, Davies, Firoza and Little, Paul
(2024)
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.
The Lancet Rheumatology, 6 (7).
e424-e437.
ISSN 2665-9913
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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.
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| Additional Information: | Acknowledgments: We thank the SupportBack 2 trial oversight groups that oversaw this research, along with the broader team at Southampton Clinical Trials Unit. We thank Solent NHS Trust for hosting this trial, the support they provided for obtaining funding, and the continuing support for the screening of participants. We would also like the thank all the physiotherapists who provided telephone support in the trial and all the participants who took part. Funding information: This study was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment (project 16/111/78). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. LY is an NIHR Senior Investigator and her research programme is partly supported by NIHR Applied Research Collaboration-West and NIHR Health Protection Research Unit for Behavioural Science and Evaluation. NEF is funded through an Australian National Health and Medical Research Council Investigator grant (ID 2018182). |
| Faculty \ School: | Faculty of Medicine and Health Sciences > Norwich Medical School |
| UEA Research Groups: | Faculty of Medicine and Health Sciences > Research Groups > Norwich Clinical Trials Unit Faculty of Medicine and Health Sciences > Research Groups > Health Services and Primary Care Faculty of Medicine and Health Sciences > Research Groups > Health Economics Faculty of Medicine and Health Sciences > Research Centres > Population Health |
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| Depositing User: | LivePure Connector |
| Date Deposited: | 21 Mar 2024 12:31 |
| Last Modified: | 25 Jun 2024 08:30 |
| URI: | https://ueaeprints.uea.ac.uk/id/eprint/94735 |
| DOI: | 10.1016/S2665-9913(24)00086-9 |
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