Title: Better Outcomes for Older people with Spinal Trouble (BOOST)
Funder: Department of Health and Social Care

Abstract: Aims and objectives To reduce the burden of low back pain (LBP) in older people living in the community, by providing evidence based treatment strategies, improved understanding of prognosis and greater knowledge. Background and rationale Intervening effectively on LBP in primary care could yield substantial benefit, but many older people either do not consult, or GPs do not prioritise LBP treatment for them. We will focus our efforts to refine and evaluate an intervention for LBP in older people on neurogenic claudication (NC) due to lumbar spinal stenosis. This is a condition commonly due to narrowing of the spinal canal, due to degeneration, placing pressure on spinal nerves and blood vessels causing pain and other symptoms. NC is sometimes managed with physiotherapy or surgery. Neither has a strong evidence base. Physiotherapy techniques are used in clinical practice, but could be enhanced by pain management, behavioural and gerontological rehabilitation strategies. Alongside we will develop a prognostic tool that will help clinicians, researchers and patients to understand better what types of LBP are serious for older people, and how LBP interacts with other factors or conditions. These two projects will share a recruitment strategy, approaching potential participants from the same GP practices which will increase research efficiency by maximising the use of the data collection opportunities. Research plan The research is planned in two phases. Phase 1 (first 30 months) comprises Project 1 and 2, along with a report at 24 months. Phase 2 (second 30 months) comprises the remaining projects. Project 1: Refinement of a physiotherapy intervention for NC We will integrate the most up to date knowledge of exercise, behavioural and pain management strategies, alongside practical issues. Project 2: Feasibility We will evaluate the feasibility of conducting a randomised controlled trial and prognostic study. We will involve a minimum of 11 GP practices in two regions (prognostic study) and have set targets to recruit between 50 and 118 people to the RCT during the feasibility phase indicating that it would be possible to conduct the full RCT. We would retain these participants in the analysis of the main RCT. We will also collect qualitative information on the intervention as experienced by participants and pilot the qualitative study design to be used alongside the definitive trial in Project 4. Project 3: Developing a prognostic tool. The sample will be 1000 people recruited through primary care with complete data at 2 year follow up. We will collect data related to LBP, generalised pain, general health and mobility that will be used to develop a prognostic tool to identify the LBP presentation likely to result in poor outcomes related to mobility (primary model), disability, frailty and falls. Project 4: A pragmatic randomised controlled trial of physiotherapy for neurogenic claudication and a parallel, longitudinal qualitative study, process and economic evaluation We will recruit a minimum of 355 patients with NC from primary care and secondary care musculoskeletal hubs. We will test the physiotherapy intervention developed in project 1. Follow up will be 1 year with a parallel, longitudinal qualitative study, process and economic evaluation. Project 5: Predictors of the participants response to treatment We will explore the role of MRI of the spinal canal in determining response to physiotherapy and examine a small selection of other sub-grouping variables to explore who will respond best to physiotherapy. Project 6: GP perspectives, project integration and preparation for implementation The process of engaging patients in our research studies will be different than those operating in routine clinical practice. We will study the perspectives of GPs through a series of focus groups to help inform the final integration of the project outputs and, if appropriate, on-going implementation studies and dissemination. Dissemination & projected outputs We will disseminate results broadly through different targeted media including web-summaries, electronic media, academic and lay publication. We will ensure full access to the intervention, and transparent reporting of all phases of our research. Relevant expertise & experience of the research team Our team is multi-disciplinary and experienced in systematic reviews, large scale epidemiological surveys, intervention development and evaluation of complex interventions, and primary care. We include experts in statistics, clinical trials, health economic analysis, surgery, physiotherapy, psychology and qualitative research. We are strongly committed to working with patient and user groups to refine and deliver research. Patient and public involvement We have a firm strategy to ensure continued effective input throughout the projects. Management & Governance, including programme management and ethical implications The programme is being run by the Centre for Rehabilitation Research, with support from the Oxford Clinical Trials Research Unit and Centre for Statistics in Medicine at the University of Oxford. We are collaborating with the University of Warwick. We will be dealing with older people, some may have cognitive impairment.

Lay abstract: Lower back pain (LBP) is now recognised as the leading disabling condition in the world. LBP is a highly variable condition, with many different causes and patterns of presentation. Over 70% of people will suffer with LBP in their lifetime, and the chance of having the most serious forms of LBP is greatest in later life. LBP is associated with mobility decline and falls in older people, and in turn, loss of independence and frailty. Conversely, this is the time in life when GPs and patients are least likely to target LBP for treatment. The reasons are complicated. In later life people are much more likely to have other health conditions which they think are a greater priority for treatment. Some older people just grin and bear the pain accepting it as part of ageing. GPs and older people may not recognise the importance of LBP to the development of frailty and decline in later life. Although there is a large body of research in LBP, this has focused almost exclusively on younger people. Hence there is little guidance appropriate to older people. We suspect older people respond and react differently to the common treatments for LBP. Our aim is twofold. The first is to help primary health care teams, patients and their carers recognise when LBP is a useful treatment target in older people, and to explore and hopefully counter prejudices held by older people and clinicians. Secondly, to provide evidence that physiotherapy might benefit people with a serious form of LBP unique to old age called neurogenic claudication (NC). NC results from narrowing of the spinal canal due to degeneration putting pressures on nerves and blood vessels. Our objectives are: To refine a physiotherapy intervention for NC (Project 1). To complete a feasibility study for a prognostic study and clinical trial of the NC intervention in the UK NHS (Project 2) To develop a tool that will help clinicians and older people recognise when and what types of LBP are important targets for treatment for older people. The outcomes will be mobility disability (primary model), disability, frailty and falls (Project 3). If feasible, to undertake a definitive randomised controlled trial demonstrating that access and participation in a physiotherapy intervention for NC can improve important outcomes including pain, disability, mobility, frailty and falls (Project 4). Explore whether MRI scans and other factors can help determine who will and will not respond to this treatment (Project 5). To integrate the findings of the trial and the prognostic tool into a package of treatments that can be used in primary care and other settings. This will include exploring GPs attitudes and beliefs to inform implementation and future research (Project 6).

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING;6.7 PHYSICAL
Health categories: NEUROLOGICAL