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

Supporting self-management of low back pain with an internet intervention with and without telephone support in primary care: A randomised controlled trial of clinical and cost-effectiveness (SupportBack 2)
Supporting self-management of low back pain with an internet intervention with and without telephone support in primary care: A randomised controlled trial of clinical and cost-effectiveness (SupportBack 2)
Background Low back pain (LBP) 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 LBP without serious spinal pathology were block randomised using computer algorithms stratified by disability level and telephone-support centre to: 1) usual care, 2) usual care + SupportBack, 3) usual care + SupportBack + physiotherapist telephone-support (three brief calls). Primary outcome: LBP-related disability (Roland Morris Disability Questionnaire (RMDQ) at six weeks, three months, six months and 12 months using a repeated measures model, analysed by intention to treat using 97.5% Confidence Intervals (CIs). A parallel economic evaluation from a health services perspective was used to estimate cost-effectiveness. People with lived experience of LBP were involved in this trial and its reporting from the outset. Trial registration: ISRCTN14736486
Findings 825 participants were randomised (274 usual care, 275 SupportBack only, 276 SupportBack + telephone-support). Over half (58%) were female and 42% were male. Follow-up rates were 83% at 6 weeks, 72% at 3 months, 70% at 6 months, and 79% at 12 months. For the primary analysis, 736 participants were analysed (respectively 249, 245, 242). Small reductions in RMDQ over 12 months compared to usual care occurred in the SupportBack group (adjusted mean difference -0.5, 97.5% CI -1.2 to 0.2, p=0.085) and SupportBack + telephone-support group (-0.6, 97.5% CI -1.2 to 0.1, p=0.048). These differences were not significant at a significance level of 0.025. There were no related Serious Adverse Events (SAEs). 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 QALY threshold of £20,000 compared to usual care.
Interpretation The internet interventions did not significantly reduce LBP-related disability across 12 months compared to usual care. They were likely cost-effective and safe. Clinical effectiveness, cost-effectiveness and safety should be considered together when determining whether to apply these interventions in clinical practice.
2665-9913
Geraghty, Adam W.A.
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Becque, Taeko
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Roberts, Lisa C.
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Hill, Jonathan C.
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Yardley, Lucy
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Stuart, Beth
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Turner, David A.
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Hay, Elaine
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Griffiths, Gareth
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Webley, Frances
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Durcan, Lorraine
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Hughes, Stephanie
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Bathers, Sarah
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Butler-Walley, Stephanie
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Wathall, Simon
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Mansell, Gemma
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et al.
Geraghty, Adam W.A.
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Becque, Taeko
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Roberts, Lisa C.
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Hill, Jonathan C.
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Foster, Nadine E.
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Yardley, Lucy
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Stuart, Beth
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Turner, David A.
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Hay, Elaine
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Durcan, Lorraine
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Morgan, Alannah
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Hughes, Stephanie
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Bathers, Sarah
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Butler-Walley, Stephanie
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Wathall, Simon
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Davies, Firoza
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Little, Paul
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Geraghty, Adam W.A., Becque, Taeko and Roberts, Lisa C. , et al. (2024) Supporting self-management of low back pain with an internet intervention with and without telephone support in primary care: A randomised controlled trial of clinical and cost-effectiveness (SupportBack 2). The Lancet Rheumatology. (In Press)

Record type: Article

Abstract

Background Low back pain (LBP) 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 LBP without serious spinal pathology were block randomised using computer algorithms stratified by disability level and telephone-support centre to: 1) usual care, 2) usual care + SupportBack, 3) usual care + SupportBack + physiotherapist telephone-support (three brief calls). Primary outcome: LBP-related disability (Roland Morris Disability Questionnaire (RMDQ) at six weeks, three months, six months and 12 months using a repeated measures model, analysed by intention to treat using 97.5% Confidence Intervals (CIs). A parallel economic evaluation from a health services perspective was used to estimate cost-effectiveness. People with lived experience of LBP were involved in this trial and its reporting from the outset. Trial registration: ISRCTN14736486
Findings 825 participants were randomised (274 usual care, 275 SupportBack only, 276 SupportBack + telephone-support). Over half (58%) were female and 42% were male. Follow-up rates were 83% at 6 weeks, 72% at 3 months, 70% at 6 months, and 79% at 12 months. For the primary analysis, 736 participants were analysed (respectively 249, 245, 242). Small reductions in RMDQ over 12 months compared to usual care occurred in the SupportBack group (adjusted mean difference -0.5, 97.5% CI -1.2 to 0.2, p=0.085) and SupportBack + telephone-support group (-0.6, 97.5% CI -1.2 to 0.1, p=0.048). These differences were not significant at a significance level of 0.025. There were no related Serious Adverse Events (SAEs). 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 QALY threshold of £20,000 compared to usual care.
Interpretation The internet interventions did not significantly reduce LBP-related disability across 12 months compared to usual care. They were likely 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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SupportBack 2 RCT accepted manuscript - Accepted Manuscript
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Accepted/In Press date: 20 March 2024

Identifiers

Local EPrints ID: 489476
URI: http://eprints.soton.ac.uk/id/eprint/489476
ISSN: 2665-9913
PURE UUID: ed9ffee3-5d55-4d31-9ea4-f952bf51714f
ORCID for Adam W.A. Geraghty: ORCID iD orcid.org/0000-0001-7984-8351
ORCID for Taeko Becque: ORCID iD orcid.org/0000-0002-0362-3794
ORCID for Lisa C. Roberts: ORCID iD orcid.org/0000-0003-2662-6696
ORCID for Lucy Yardley: ORCID iD orcid.org/0000-0002-3853-883X
ORCID for Gareth Griffiths: ORCID iD orcid.org/0000-0002-9579-8021
ORCID for Paul Little: ORCID iD orcid.org/0000-0003-3664-1873

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Date deposited: 25 Apr 2024 16:31
Last modified: 04 Jul 2024 01:35

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Contributors

Author: Taeko Becque ORCID iD
Author: Lisa C. Roberts ORCID iD
Author: Jonathan C. Hill
Author: Nadine E. Foster
Author: Lucy Yardley ORCID iD
Author: Beth Stuart
Author: David A. Turner
Author: Elaine Hay
Author: Frances Webley
Author: Lorraine Durcan
Author: Alannah Morgan
Author: Stephanie Hughes
Author: Sarah Bathers
Author: Stephanie Butler-Walley
Author: Simon Wathall
Author: Gemma Mansell
Author: Malcolm White
Author: Firoza Davies
Author: Paul Little ORCID iD
Corporate Author: et al.

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