Supporting self-management with an internet intervention for low back pain in primary care: An RCT (SupportBack 2)

Abstract

Background: low back pain (LBP) is highly prevalent and a leading cause of disability. Internet delivered interventions may provide rapid and scalable support for behavioural self-management. There is a need to determine the effectiveness of highly accessible, internet-delivered support for self-management for LBP.

Objective: To determine the clinical and cost-effectiveness of an accessible internet intervention, with and without physiotherapist telephone support, on LBP-related disability.

Design: a multicentre, pragmatic, three parallel arm randomised controlled trial with parallel economic evaluation.

Setting: participants were recruited from 179 UK primary care practices.

Participants: participants had current LBP without indicators of serious spinal pathology

Interventions: participants were block randomised by a computer algorithm (stratified by severity and centre) to one of three trial arms: 1) usual care, 2) usual care + internet intervention, 3) usual care + internet intervention + telephone support. ‘SupportBack’ was an accessible internet intervention. A physiotherapist telephone support protocol was integrated with the internet programme, creating a combined intervention with three brief calls from a physiotherapist.

Outcomes: the primary outcome was LBP-related disability over 12 months using the Roland Morris Disability Questionnaire (RMDQ) with measures at 6 weeks, 3, 6 and 12 months. Analyses used repeated measures over 12 months, were by intention-to-treat and used 97.5% Confidence Intervals (CIs). The economic evaluation estimated costs and effects from the NHS perspective. A cost-utility study was conducted using quality adjusted life years (QALYs) estimated from the EQ-5D-5L. A cost-effectiveness study was estimated cost per point improvement in RMDQ. Costs were estimated using data from general practice patient records. Researchers involved in data collection and statistical analysis were blind to group allocation.

Results: 825 participants were randomised (274 to usual primary care, 275 to usual care + internet intervention, 276 to the physiotherapist supported arm). 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 (249 usual care, 245 internet intervention, 242 telephone support). There was a small reduction in RMDQ over 12 months compared to usual care following the internet intervention without physiotherapist support (adjusted mean difference of -0.5, 97.5% CI -1.2 to 0.2, p=0.085) and the internet intervention with physiotherapist support (-0.6, 97.5% CI -1.2 to 0.1, p=0.048). These differences were not statistically significant at the level of 0.025. There were no related Serious Adverse Events. Base case results indicated both interventions could be considered cost-effective compared to usual care at a value of a QALY of £20,000, however, the SupportBack group dominated usual care, being both more effective and less costly.

Conclusions: the internet intervention, with or without physiotherapist telephone support, did not significantly reduce LBP-related disability across 12 months, compared to usual primary care. The interventions were safe and likely to be cost-effective. Balancing clinical effectiveness, cost-effectiveness, accessibility and safety findings will be necessary when considering use of these interventions in 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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