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)

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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Identifiers

ORCID for Adam W.A. Geraghty: orcid.org/0000-0001-7984-8351

ORCID for Taeko Becque: orcid.org/0000-0002-0362-3794

ORCID for Lisa C. Roberts: orcid.org/0000-0003-2662-6696

ORCID for Lucy Yardley: orcid.org/0000-0002-3853-883X

ORCID for Gareth Griffiths: orcid.org/0000-0002-9579-8021

ORCID for Paul Little: orcid.org/0000-0003-3664-1873

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