Better Outcomes for Older people with Spinal Trouble (BOOST)

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 imp