Title: Improving outcomes from the treatment of back pain
Funder: Department of Health (England)

Abstract: Low back pain (LBP) is a common and costly disorder. Several therapist-delivered interventions are available for LBP; but effect sizes are, typically, small to moderate. Draft NICE guidance suggests that acupuncture, manual therapy, and exercise programmes should be available for all patients with low back pain lasting for more than six weeks and less than one year.[1] Additionally, our recently completed trial of a group cognitive behavioural approach, mainly delivered by physiotherapists, found this approach to be effective (BeST).[2] The selection of treatment modalities usually takes place at the first physiotherapy consultation; increasingly this will be after self-referral.[3] There is considerable variation in current practice for treating LBP.[4-5] This research focuses on how to match back pain patients attending for physiotherapy to different treatments. The aim is to improve the provision of effective and cost-effective back pain treatments by the NHS. Successfully identifying sub-groups of LBP patients who will gain greatest benefit from different treatments is a high international research priority.[6] This challenging research question does not lend itself to being tested in a randomised controlled trial (RCT). Any RCT designed to test use of sub-grouping will be several times larger than the largest existing RCTs Even if such a trial were run, any simple design would only test use of one screening tool to choose between two interventions with only one outcome measure. More complex designs testing multiple baseline measures, and multiple interventions, would be implausibly large. We are proposing a mixed methods programme of research to produce the evidence needed by patients, their clinical advisors, and health service purchasers to deliver the “right treatment, to the right person at the right time”.[7] To achieve this there will be six linked work streams which will explore the complex relationship between patient preferences, demographic factors, patient history, clinical findings, and outcomes from different treatments. The clinical aspects of this programme will be based in the physiotherapy department at Coventry PCT which receives around 3,600 new referrals for back pain treatment per year. Workstream A We will describe and explore the origins, patterns of change and effects of patients’ preferences, priorities and expectations in relation to their back pain and its treatment, how they value different health outcomes, and what they consider meaningful treatment benefit. We will do: 1) a systematic review, 2) a qualitative cohort study, 3) video studies of the decision making process, 4) qualitative studies on expectations from treatment , 5) conjoint analyses to elicit patient preferences over process and outcomes These studies, as well as producing important data in their own right, will inform subsequent statistical analyses and economic modelling. Workstream B To facilitate our quantitative analyses, we will develop a repository of individual patient data from RCTs testing therapist-delivered interventions for LBP. Workstream C Examining the validity and reliability of commonly used physical measurements and patient reported measures used in LBP. This will involve reviews of existing literature and selected new data collection on both patient completed measures and clinical examination. This will inform choice of measures used in workstream D. Workstream D Will seek to identity practical clinical prediction rules that can be used to inform management of LBP. Informed by work stream A & C, this will include systematically reviewing existing studies and new analyses of pooled datasets generated in work steam B. Workstream E Drawing on work streams A-D we will develop a health economic model that will allow us to estimate the incremental cost-effectiveness of different strategies for the use of treatments for LBP. Workstream F Finally, we will draw together all the findings from this programme of work, and other ongoing work, to produce an overall synthesis of how best to guide patients and their clinical advisors in choosing back pain treatments. This proposed programme of work is a result of collaboration between; primary care, academic institutions and patient and user organisations, namely: Coventry Teaching PCT, Warwick Medical School Clinical Trials Unit (CTU), the Health Economics Research Group at Brunel University, Innovation, Knowledge & Organizational Networks (IKON) group at Warwick Business School, BackCare, and Universities/User Teaching and Research Action Partnership (UNTRAP).[8] There will be two user groups; drawn nationally from BackCare’s helpline volunteers and locally from UNTRAP to include a wide spectrum of people with back pain who can inform this work.


Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: MUSCULOSKELETAL;NEUROLOGICAL