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| UK-Back Skills Training Trial (UK-BeST) A multi-centred randomised controlled trial of a primary-care based cognitive behavioural program (CBP) for low back pain (LBP) |
| Source of record | UK Trials |
| ISRCTN | ISRCTN54717854 |
| Date ISRCTN assigned | 23/09/2003 |
| Local reference number(s) | HTA 01/75/01 |
| Public title | UK-Back Skills Training Trial (UK-BeST) A multi-centred randomised controlled trial of a primary-care based cognitive behavioural program (CBP) for low back pain (LBP) |
| Scientific title | |
| Acronym | UK-BeST |
| Disease/condition/study domain | Low Back Pain |
| Study hypothesis | 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | West Midlands Multi-Centred Research Ethics Committee, Birmingham UK (MRC/03/7/04) provided the ethical review and approval. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. People with at least moderately troublesome low back pain of six weeks duration 2. Able to give informed consent 3. Aged over 18 years |
| Participants - exclusion criteria | Exclusions will be based on pre-specified factors associated with serious pathologies. |
| Patient information material | |
| Anticipated start date | 06/10/2003 |
| Anticipated end date | 05/10/2008 |
| Status of trial | Ongoing |
| Target number of participants | 700 |
| Interventions | Please note that, as of 15 January 2008, the start and anticipated end date of this trial have been updated from 1 October 2003 and 30 September 2006 to 6 October 2003 and 5 October 2008, respectively. Interventions: Group CBP, utilising an individualised assessment and promotion of self-management by 1. Patient education to counter negative beliefs about LBP 2. Use of cognitive re-structuring techniques to improve coping skills and self-efficacy (focusing on occupation and activity) 3. Goal setting, led by the paticipants 4. Pacing skills 5. Graded physical activity programme 6. Effective communication with health professionals. Groups will allow for up to 6 hours of face-to-face contact with therapists, and will be conducted in a community or primary care facility. |
| Primary outcome measure(s) | 1. Pain and Disability measured using the Roland and Morris Questionnaire at months 0, 3, 6, 12 2. Pain measured using the Von Korff Scale at months 0, 3, 6, 12 |
| Secondary outcome measure(s) | Secondary outcome measures: 1. Occupational and other limitations measured by the numbers of days off work, reduced activity and bed rest at months 0, 3, 6, 12 2. Health related quality of life including physical and mental health measured by Short Form 12 version 2 at months 0, 3, 6, 12 3. Back Pain Beliefs measured using Fear avoidance scale (1st five items only)* at months 0, 3, 6, 12 4. Self-efficacy measured using the Pain self-efficacy questionnaire at months 0, 3, 6, 12 5. Satisfaction with treatment measured using the single item rating of satisfaction with treatment at months 12 Economic analysis: 1. Resource Use measured using the resource use questionnaire at months 6 and 12 2. Health related quality of life; time trade off score measured using the EQ-5D (health utility) at months 0, 6, 12 |
| Publications | Study protocol: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids= 17316434 |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Sponsor name | Department of Health (UK) |
| Sponsor details | Quarry House Quarry Hill Leeds United Kingdom LS2 7UE |
| Sponsor email | Sheila.Greener@doh.gsi.gov.uk |
| Sponsor website | http://www.dh.gov.uk/en/index.htm |
| Contact name | Prof Sarah Elizabeth Lamb |
| Contact details | Centre for Primary Health Care Studies University of Warwick Room 104 Avon Building Westwood Campus Coventry United Kingdom CV4 7AL |
| Contact telephone | +44 024 7657 4657 |
| Contact email | s.lamb@warwick.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN54717854 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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