Title: Refining Community-based Rehabilitation and Improving the Care Pathway for People with Spinal Stenosis
Funder: Health Education England

Abstract: Lumbar spinal stenosis (LSS) is a common condition in older adults where the spaces around the spinal nerves become narrowed because of degenerative changes. Typical symptoms of leg pain and numbness are provoked by walking and often significantly impact on activity levels, increasing the risks of comorbidities, falls, and loss of independence, and leading to substantial health costs. The growing number of people seeking care for LSS symptoms due to our ageing population is likely to impact significantly on healthcare resources in the future. There is no definitive cure or optimal treatment. Various treatments likely provide some benefit, including advice, pain medications, exercise and rehabilitation programmes, and surgery. Current guidelines consistently recommend non-surgical options first. However, there is little evidence to inform the selection, dose or sequencing of non-surgical treatments, resulting in variability in care, potentially leading to poor outcomes, unnecessary use of more invasive treatments and inefficient use of healthcare resources. A large clinical trial (BOOST) is currently evaluating effectiveness of a rehabilitation programme specifically designed for patients with LSS based on empirical and limited research evidence. Even if effective, it is unlikely to be appropriate or affordable for everyone diagnosed with LSS to be offered this 12-week rehabilitation programme in routine NHS care, and there is therefore a need for stratification to maximise uptake and streamline resource use. The aims of the proposed reserach are to develop an agreed, evidence-based care pathway for LSS, and a refined rehabilitation option which delivers targeted treatment content and dose. The specific objectives will be to 1) understand how treatment content and dose affect outcomes and costs in rehabilitation2) understand variability in response to rehabilitation3) design a care pathway from diagnosis through appropriate steps of treatment, incorporating a refined rehabilitation package These areas will be explored fully using mixed research methodology: firstly, structured analysis of existing research literature and secondary analysis of BOOST trial data will inform the refinement of the rehabilitation programme content; secondly additional data collected from BOOST participants will be analysed to understand dose-response and variability in treatment response, and secondary analysis of BOOST trial data will be used to estimate dose-related costs; and finally consensus building methods will be used to design the refined rehabilitation option(s) and the overall stepped care pathway. Embedding parts of the proposed research work in the established NIHR Programme Grant- funded BOOST trial will ensure high-quality trial data for secondary analysis of treatment content and dose. Collection of additional data from trial participants has been planned in collaboration with the BOOST research team to evaluate dose-response and variability in treatment response. The Delphi consensus process will target international LSS experts and subsequent surveys and structured focus groups will target UK-based stakeholder groups to ensure the final pathway design is relevant to the NHS. The proposed research fits directly with HEE priorities in addressing a clinical need for improved community-based rehabilitation for long-term conditions, and a service-provision need to optimise use of healthcare resources. The knowledge generated from the planned analyses will have immediate impact for clinical guidance and informing treatment choice for patients with LSS, and will support the continued development of my clinical and research expertise in nonsurgical treatments for LSS. Beyond this clinical lectureship, I would aim to evaluate clinical and cost-effectiveness of the resultant care pathway in a randomised controlled trial as part of an NIHR senior clinical lectureship. Wider benefits will be the development of clinical and academic leadership skills, in addition to methodological skills in analysing treatment response which will be transferrable to many other long-term musculoskeletal conditions providing a direction of travel for future research.

Lay abstract: Lumbar spinal stenosis (LSS) is a common condition especially in people over the age of 65 years, which results from wear in the spine causing narrowing of the spaces around the spinal nerves. The condition can lead to significant pain and loss of mobility.Typical symptoms of pain, heaviness and numbness in the legs are brought on by walking and relieved by sitting down or bending forward which widens the space for the spinal nerves. Because symptoms are made worse by walking, LSS can affect people's activity levels and independence. Some patients benefit from available treatments which vary from advice on managing symptoms, pain medications, to exercise treatments, spinal injections and spinal surgery, but we do not know which treatments are best offered to which patients.Non-surgical treatments are the first choice for most people with LSS, but we do not yet have a clear understanding of what we should include in a package of non-surgical care or how to tailor treatments to different individuals. Currently, treatment varies widely according to what is available, patient preference or what individual clinicians believe will work best, but there are no clear guidelines to help make fully informed choices. An important objective of the proposed research is to develop a clear treatment pathway. This would provide a treatment guide from the point of diagnosis through a series of appropriate treatment steps. The goal of stepped care is for each patient to be given the treatment they need reserving more intensive treatments for people unable to manage with the less intensive treatments. People who manage their symptoms successfully with the least intensive treatments will not need to proceed to more intensive treatments which generally have greater risks and burden for patients and higher costs. The aim is to provide a high standard of care to people with LSS, whilst making the best use of healthcare resources. Development of this treatment pathway will be achieved by using both evidence from analysing research data and from a panel of research and cinical experts and patients with LSS. The second objective will be to fine-tune a rehabilitation programme which will be integrated as one of the steps in the treatment pathway. Based on current research evidence, we believe that a rehabilitation programme which includes exercises for improving strength, general fitness and balance, and approaches to improve coping mechanisms is likely to be beneficial at least for some people with LSS. I am currently involved in a UK-wide clinical trial (the BOOST trial) set up by the University of Oxford which will look at the benefits of a 12-week programme of group classes incorporating all of these treatment elements. One of the tensions that we have in conducting high quality research like this is that even if found to be effective, it is unlikely that a full 12-week rehabilitation programme can be provided to all patients who are diagnosed with LSS each time they require treatment, given the increasingly stretched resources of the NHS. I have therefore worked with the BOOST research team in Oxford, and with a research team in Leeds to plan this application which aims to understand what dose and which types of non-surgical treatment work best. We will analyse which elements of the BOOST rehabilitation programme are most beneficial (for example are strengthening exercises more beneficial than fitness exercises?) so that the programme can be further refined. We will also analyse data to see how different participants respond (some people may do well after 3 classes and not need all 12 classes in the BOOST programme, while others may not benefit even from the full 12-week programme). To understand this, we will ask each participant questions about how they are managing and how their symptoms are affecting their walking at regular intervals during the 12-week programme sto monitor individual patterns of response to treatment. The overall aim of the research in this fellowship is to improve patient care for people with LSS and to make the best use healthcare resources by producing a clear treatment pathway based on evidence, and developing a refined rehabilitation programme within it. Public and service users who have already been involved in the design of the proposed research will continue to support the development of the stepped care pathway. The results of this research will be used to inform clinical pathway decisions in the future, and will be shared through public and patient forums, as well as using traditional research and professional channels of journal publications and conference presentations.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;7.3 MANAGEMENT AND DECISION MAKING
Health categories: MUSCULOSKELETAL;NEUROLOGICAL