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

Background: Low back pain 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 of low back pain. Objective: To determine the clinical and cost-effectiveness of an accessible internet intervention, with and without physiotherapist telephone support, on low back pain-related disability. Design: A multicentre, pragmatic, three parallel-arm randomised controlled trial with parallel economic evaluation. Setting: Participants were recruited from 179 United Kingdom primary care practices. Participants: Participants had current low back pain 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 and (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 low back pain-related disability over 12 months using the Roland-Morris Disability Questionnaire 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. The economic evaluation estimated costs and effects from the National Health Service perspective. A cost-utility study was conducted using quality-adjusted life-years estimated from the EuroQol-5 Dimensions, five-level version. A cost-effectiveness study estimated cost per point improvement in the Roland-Morris Disability Questionnaire. Costs were estimated using data from general practice patient records. Researchers involved in data collection and statistical analysis were blind to group allocation. Results: Eight hundred and twenty-five participants were randomised (274 to usual primary care, 275 to usual care + internet intervention and 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 the Roland-Morris Disability Questionnaire over 12 months compared to usual care following the internet intervention without physiotherapist support (adjusted mean difference of -0.5, 97.5% confidence interval -1.2 to 0.2; p = 0.085) and the internet intervention with physiotherapist support (-0.6, 97.5% confidence interval -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 that both interventions could be considered cost-effective compared to usual care at a value of a quality-adjusted life-year 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 low back pain-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 the use of these interventions in practice. Trial registration: This trial is registered as ISRCTN14736486. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/111/78) and is published in full in Health Technology Assessment; Vol. 29, No. 7. See the NIHR Funding and Awards website for further award information.