Details of HTA project
Last updated: 31 August 2010 - Next update due: 7 September 2010
Research type: |
Primary Research (e.g. trial) |
Project title: |
A multi-centred randomised controlled trial of a primary-care based cognitive behavioural programme for low back pain (UK-Best) |
 Outputs in journals arising from this project
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Project ref: |
01/75/01 |
Cost: |
£1,014,245 |
Chief Investigator : |
Professor Sarah (Sallie) Lamb, Director, Warwick Clinical Trials Unit, Warwick Clinical Trials Unit, University of Warwick |
Start Date: |
October 2003 |
Estimated date of publication in HTA journal series: |
Mid 2011. This date takes account of time for report preparation and printing based on current average times for these activities. |
Plain English Summary |
Background The management of low back pain remains a challenge to primary care. Considerable improvements have been made in identifying risk factors, and also in understanding the processes involved in the development of chronic low back pain (LBP). Previous studies have shown the importance of psychological and social risk factors in the development of LBP. These factors include psychological distress, occupational factors such as work dissatisfaction and poor health behaviours such as physical inactivity. This study is designed to determine whether a Cognitive Behavioural Approach (CBA), designed to address these risk factors, is effective in preventing disability, work absence and health services use associated with low back pain. Aim 1.To estimate the clinical effectiveness of active management in general practice versus active management in general practice plus a cognitive behavioural package for low back pain. 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. Methods The study is taking place in various locations across England. Research nurses working in general practices will recruit participants. Eligible participants should be aged 18 or over, have low back pain of moderate troublesomness for at least 6 weeks and be able to give informed consent. Once the research nurse has assessed eligible participants a computer programme will decide which group they will be allocated to. One group will receive active care from the general practice and the other group will receive active care together with a course involving CBA. This approach involves participants being assessed by a specially trained therapist and attending 6 group sessions which will promote self-management and behavioural change. All participants will be followed up at 3, 6 and 12 months with postal questionnaires. We hope to achieve the following: reduction of disability associated with LBP including activity limitations and occupational disability; reduction of pain or improved tolerance of pain symptoms; reduction of further medical, rehabilitation or surgical treatment for LBP; improvements in quality of life. Back Skills Training (BeST) Trial The University of Warwick Centre for Primary Health Care MRC General Practice Research Framework A randomised study of treatments for back pain in primary care, funded by the NHS R&D HTA programme (ISRCTN54717854) |
Project Abstract: |
The problem: Low back pain (LBP) is a major public health problem. In any year, about 37% of the UK population report LBP, but not all people consult their general practitioner, or have long lasting symptoms. LBP has a substantial impact on the UK economy. Direct health care costs associated with LBP were estimated to be £1,628 million in 1998. Indirect costs, including lost production are even higher. Cognitive Behavioural Therapy (CBT): Over the recent years there has been considerable interest in CBT as a treatment for LBP, but few large controlled trials. CBT aims to empower people to better manage their back pain by learning skills of self-management. Important components of CBT are learning coping and pacing skills, non-pharmacological management of pain, countering negative beliefs about back pain and a graded activity programme in which people learn how to set themselves realistic goals. We have decided to use a group setting to deliver CBT as opposed to an individual treatment. We hope that people will be able to gain benefit from talking to one another, as has been shown in CBT programmes designed for other conditions. The study: Up to 700 people with a diagnosis of LBP, resulting in at least moderately troublesome symptoms and of at least 6 weeks duration will be identified through 93 practices of the Medical Research Council's General Practice Research Framework http://www.mrc-gprf.ac.uk/index.html. Potential participants will be invited to participate in a trial in which they will be allocated on a random basis to one of two treatment arms (1) advice from their general practice (2) advice plus a group based cognitive behavioural program. The costs of each strategy, and the clinical effects of the treatment will be monitored for a year. |
MeSH* index primary terms: |
LOW-BACK-PAIN Q-therapy; COGNITIVE-THERAPY; FAMILY-PRACTICE |
MeSH* index secondary terms: |
HUMAN; ADOLESCENT; ADULT; MIDDLE-AGED; AGED; MULTICENTER-STUDY; RANDOMIZED-CONTROLLED-TRIAL; CLINICAL-TRIAL |
NRR* number, if applicable: |
N0484131804 (*National Research Register). The National Research Register was a public database of ongoing and recently completed research projects funded by, or of interest to, the United Kingdom's National Health Service (NHS). It is now an archive of projects from early 2000 to September 2007. Search the NRR archive. |
ISRCTN* number: | ISRCTN 54717854 (*International Standard Randomised Controlled Trial Number) URL of this project on the Controlled Trials Website: http://www.controlled-trials.com/ISRCTN54717854 |
Project Protocol: |
Project protocol (pdf format, 118 kbytes) |
URL of this page: |
http://www.hta.ac.uk/1358 |
Outputs from this project
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