Title: Supporting self-management of low back pain with an internet intervention in primary care: A randomised controlled trial of clinical and cost-effectiveness (SupportBack 2)
Funder: Department of Health and Social Care

Abstract: Design: A multicentre, three-parallel arm randomised controlled trial comparing the effectiveness and cost-effectiveness of usual care + internet intervention vs. usual care + internet intervention + physiotherapist telephone support vs. usual care alone in reducing LBP-related disability over 12 months. Setting: 80-100 primary care practices from Wessex and the West Midlands. A recruitment pathway will also be provided for self-referral NHS physiotherapy services. Target population: Primary care patients over 18 years of age with current LBP. Inclusion/Exclusion criteria: Inclusion: current LBP; access to the internet; ability to read/understand English. Exclusion: under 18; indicators of serious spinal pathology; pregnancy. Health technologies being assessed: The ‘SupportBack’ internet intervention delivers a 6-week, tailored programme focused on graded goal setting, self-monitoring, and provision of tailored feedback to encourage physical activity. Additional physiotherapist telephone support consists of 3 brief calls over the intervention period designed to address concerns and provide reassurance. The interventions will be compared to usual primary care for LBP. Measurement of costs and outcomes: A cost effectiveness analysis from a societal perspective will form a central component of this trial. The main outcome measure in the economic evaluation will be the quality adjusted life year (QALY), obtained from the EQ-5D-5L instrument. Health care resource use will be obtained from practice notes, costs borne by patients will be obtained by means of patient completed questionnaires. Following recommendations on core outcomes for LBP (28), the primary outcome for the trial will be LBP-related disability (Roland Morris Disability Questionnaire (29)), measured at 6 weeks, 3 6 and 12 months (repeated measures design). Pain intensity and range of LBP-related outcomes will be measured. A nested mixed methods process study will be included. Sample size: A lower level difference of 1.5 points on the RMDQ at the outcome time points, assuming a standard deviation of 5 in line with the feasibility study, gives an effect size of 0.30. Alpha will be set to 0.025 to allow both interventions to be independently compared with the usual care alone arm. With 4 repeated measures (6 weeks, 3, 6 and 12 months), and assuming a correlation between repeated measures of 0.7 and 90% power, requires 215 participants per arm. Allowing for 20% loss to follow up, this gives a total sample size of 806. Difference between current and planned care pathways: NICE (10) recommended first line care for LBP consists of education and self-management advice. However, currently no support exists for implementing this guideline in an evidence-based manner. The trial intervention arms will provide rapid evidence-based behavioural self-management support. Project timetables including recruitment rate: The study will run for 44 months including: 6 months trial setup; 20 months recruitment; 12 month follow-up period; 6 months trial closing, analysis and report writing. Based on the feasibility trial recruitment, we expect to recruit approximately 20-21 patients per centre, per month. Expertise in team: The team consists of world-leading experts in general practice, psychology, physiotherapy, rheumatology, trials methodology, statistics, and health economics as well as a service user with lived experience of LBP.

Lay abstract: Low back pain (LBP) is one of the most common and costly problems seen in General Practitioners (GP) surgeries today. Internet interventions may provide a new and efficient way of supporting and encouraging patients to become more active in self-managing their backs, in addition to the usual care they would receive from their GP. The aim of this study is to determine if an internet intervention called ‘SupportBack’, provided both with and without guidance from a physiotherapist over the telephone, is effective in reducing the disability LBP causes. 806 primary care patients will be recruited for a randomised controlled trial comparing 3 groups: 1. Usual care 2. Usual care + SupportBack. 3. Usual care + SupportBack + physiotherapist telephone support. SupportBack provides 6 weeks of tailored materials online to support gradual goal setting, help with monitoring of back-related activities and to provide personal feedback. SupportBack is designed to provide advice, reassurance and encourage physical activity. It was developed with the help of 22 patients with LBP. The telephone physiotherapist support will include 3 brief calls over the first 6 weeks of SupportBack use. The telephone support is aimed to help with concerns, provide reassurance and encourage taking up and staying with activity goals. Patients will be followed up at 6 weeks, 3, 6 and 12 months and asked about how LBP is affecting their daily activities, about their level of pain intensity, and a range of other LBP-related questions. The health care services the patients use will be recorded. We will test whether SupportBack with or without physiotherapist telephone support is more effective in reducing disability related to LBP compared to usual primary care alone. In addition, we will also test whether SupportBack provides value for money. We will interview trial participants to explore their experience of the care they received over the trial period, their experience of LBP and their experience of SupportBack and the telephone support for those in the intervention groups. As well as GPs, psychologists, physiotherapists, rheumatologists and statisticians, the team will include members of the public with experience of LBP; they will provide input at all stages of the study. The results of the study will be shared around the country and internationally. If SupportBack proves to be effective, we will seek rapid roll-out into the NHS, allowing GPs and physiotherapists to offer patients SupportBack as a regular part of primary health care.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: MUSCULOSKELETAL