SUPPORTING SELF-MANAGEMENT OF BACK PAIN WITH AN INTERNET INTERVENTION WITH OR WITHOUT PHYSIOTHERAPIST TELEPHONE SUPPORT: A RANDOMISED TRIAL (SUPPORTBACK 2)

A.W. Geraghty¹, T.F. Becque², L.C. Roberts², J.C. Hill³, B. Stuart¹, L. Yardley^4,5, E.M. Hay³, D. Turner⁶, G. Griffiths⁷, F. Webley⁷, L. Duncan⁷, A. Morgan⁸, S. Hughes¹, S. Bathers⁹, S. Butler-Walley⁹, S. Wathall⁹, G. Mansell¹⁰, M. White¹, F. Davies¹, P. Little¹, N.E. Foster^11,12,3

¹University of Southampton, Primary Care, Population Sciences and Medical Education, Southampton, United Kingdom, ²University of Southampton, School of Health Sciences, Southampton, United Kingdom, ³Keele University, School of Medicine, Keele, United Kingdom, ⁴University of Bristol, School of Psychological Science, Bristol, United Kingdom, ⁵University of Southampton, Department of Psychology, Southampton, United Kingdom, ⁶University of East Anglia, Norwich Medical School, Norwich, United Kingdom, ⁷University of Southampton, Southampton Clinical Trials Unit, Southampton, United Kingdom, ⁸Southampton Clinical Trials Unit, University of Southampton, Southampton, United Kingdom, ⁹Keele University, Keele Clinical Trials Unit, School of Medicine, Keele, United Kingdom, ¹⁰Aston University, School of Life and Health Sciences, Birmingham, United Kingdom, ¹¹The University of Queensland, School of Health and Rehabilitation Sciences, Brisbane, Australia, ¹²Metro North Health, Surgical Treatment and Rehabilitation Service (STARS) Education and Research Alliance, Brisbane, Australia

Background: Low back pain (LBP) is highly prevalent and a leading cause of disability. Most patients are managed in primary care where guidelines recommend advice to self-manage and stay active. Internet delivered interventions may provide rapid and scalable support for behavioural self-management however there is a need to determine the effectiveness of highly accessible web-based support for self-management for LBP.

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

Methods: A multicentre, pragmatic, three parallel arm randomised controlled trial, comparing: 1) usual primary care, 2) usual primary care + internet intervention, 3) usual primary care + internet intervention + physiotherapist telephone support. ‘SupportBack’ is an accessible internet intervention (accessed from any device with an internet connection including computers, tablets, phones), developed for patients with LBP in primary care. It was designed to support self-management through a focus on physical activity as well as behavioural advice on a range of LBP-related topics (e.g. sleep and mood), and offered a tailored self-management programme over 6 weeks. Additionally, a physiotherapist telephone support protocol was developed that could be integrated with the internet programme, creating a combined intervention. The supported arm participants were offered up to three brief calls from a physiotherapist. 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).

Results: Of 2693 adults in primary care assessed for eligibility, 825 participants were randomised (274 to usual primary care, 275 to usual care + internet intervention, 276 to the physiotherapist supported arm). Mean age was 54 years, 58% were female, 58% were in paid employment, average pain over last two weeks was 4.8 (0 no pain, 10 maximum pain), and baseline disability (RMDQ) was 7 (0 no disability, 24 maximum disability). Follow-up rates were 83% at 6 weeks, 72% at 3 months 70% at 6 months, and 79% at 12 months. 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 as originally designed. Both interventions led to significantly more participants reporting clinically important benefit (at least a 30% reduction in RMDQ) at 12 months compared to usual care (61% in both intervention arms versus 51% in usual care alone). There were no harms.

Conclusions: The internet intervention, with or without physiotherapist telephone support, had a small impact on LBP-related disability. The interventions were safe, and the internet intervention is highly scalable.

Implications: The use of this internet intervention could be considered to support behavioural self-management as an adjunct to usual primary care.

Funding acknowledgements: Funded by NIHR Health Technology Programme (HTA number 16/111/78).

Keywords:
Low back pain
Randomised controlled trial
Internet intervention

Topics:
Musculoskeletal: spine
Primary health care
Pain & pain management

Did this work require ethics approval? Yes

Institution: Health and Care Research Wales

Committee: NHS Health Research Authority and Health and Care Research Wales

Ethics number: IRAS project ID: 241956