A multi-centred randomised controlled trial of Primary-care based cognitive behavioural program for low back pain (BEST)

Lead Research Organisation: Medical Research Council

Abstract

Low back pain (LBP) constitutes a major public health problem in western industrialised societies. This study aims to investigate the effectiveness of a clinically accepted cognitive behavioural program for treating back pain in comparison with care from general practice. The study will also investigate the cost effectiveness of the cognitive behavioural program in comparison to GP care. The study is a multi-centred randomised controlled test, with blinded assessment of outcomes.

Technical Summary

Low back pain (LBP) constitutes a major public health problem in western industrialised societies. The annual rate of BP is approximately 37% and a third of people with LB experience symptoms for more than four weeks. Not all people with LBP consult a general practitioner. A recent survey reported 75% of people consulting for LBP in primary care had symptoms one year later and about 30% develop persistent disabling LBP.||The overall aim is to undertake a high-quality definitive trial of a clinically accepted cognitive behavioural program (CBA) that can be readily disseminated into primary care if successful. The model of CBA selected has the potential, if clinically effective, to be highly cost-effective. Evidence to support CBA is controversial and very limited. Unlike previous trials this study will be of sufficient quality and size to detect differences in disability, occupational variables and cost at 12 months. Occupation will include unpaid and paid work. Several systematic reviews have suggested the need for studies to identify who benefits most from CBA approaches. This has been built in to the study in a pre-defined analysis to identify important covariates in determining response to treatment.||The two main aims of BEST are:|1. To estimate the clinical effectiveness of active management in general practice versus active management in general practice plus a group based, professionally led cognitive behavioural package (CBA) for low back pain (LBP) of at least moderate troublesomeness and six weeks duration, in|(a) reduction of disability associated with LBP including activity limitations and occupational disability|(b) reduction of pain or improved tolerance of pain symptoms|(c) reduction of further medical, rehabilitation or surgical treatment for LBP|(d) Improvements in quality of life||2. To measure the cost of each strategy, including treatment and subsequent health care costs, over a period of 12 months and to estimate cost-effectiveness. |The study is a multi-centred randomised controlled test, with blinded assessment of outcomes. Participants will be randomised individually. The study will be investigator blind. Double blinding is impossible therefore a treatment credibility analysis will be used. |This study is funded by the Department of Health Research and Development Health Technology Assessment Programme

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