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

Abstract

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.

Plain language summary

Low back pain is very common; most people will experience it at some point in their lives. For some, it will limit what they do day-to-day and cause a lot of concern. The advice people with low back pain are often given is to keep themselves active and ‘self-manage’. This means working those things in their lives that will be helpful for alleviating their pain. However, often self-managing well, can require support. In this study, we wanted to know whether a website built to help people self-manage was more effective when added to the care people usually receive from their doctor. We also wanted to know whether adding phone calls from a physiotherapist made the website more effective. Finally, we explored whether these options would represent ‘good value for money’ for the National Health Service. People with low back pain were randomly split into three groups. Group one had access to normal care from their doctor; group two had access to normal care from their doctor plus access to a self-management website; group three had access to normal care from their doctor, plus access to the website, and three brief calls from a physiotherapist. As per our main focus, they answered questions about their back-pain-related disability at 4 time points, over 12 months. We found small reductions in disability between both website groups and the group who received normal care from their doctor over 12 months. These differences were not significantly different and were smaller than those we judged to be clinically important. However, the website did not cause harm and was likely to offer value for money. Overall, although the impact of the website on disability was limited, it was safe and could be accessed by a lot of people. Clinicians will need to balance these findings on impact, with access, safety and costs when deciding to offer the website.

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