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)
| ISRCTN | ISRCTN54717854 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54717854 |
| Secondary identifying numbers | HTA 01/75/01 |
- Submission date
- 17/09/2003
- Registration date
- 23/09/2003
- Last edited
- 30/09/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Sarah Elizabeth Lamb
Scientific
Scientific
Centre for Primary Health Care Studies
University of Warwick
Room 104
Avon Building
Westwood Campus
Coventry
CV4 7AL
United Kingdom
| Phone | +44 024 7657 4657 |
|---|---|
| s.lamb@warwick.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Scientific title | |
| Study acronym | UK-BeST |
| Study objectives | 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. More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/017501 Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0016/50614/PRO-01-75-01.pdf On 15/01/2008 the anticipated start and end date of this trial were changed from 01/10/2003 and 30/09/2006 to 06/10/2003 and 05/10/2008, respectively. |
| Ethics approval(s) | West Midlands Multi-Centred Research Ethics Committee, Birmingham UK (MRC/03/7/04) provided the ethical review and approval. |
| Health condition(s) or problem(s) studied | Low Back Pain |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | 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 measures | 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 |
| Overall study start date | 06/10/2003 |
| Completion date | 05/10/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 700 |
| Key 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 |
| Key exclusion criteria | Exclusions will be based on pre-specified factors associated with serious pathologies. |
| Date of first enrolment | 06/10/2003 |
| Date of final enrolment | 05/10/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Centre for Primary Health Care Studies
Coventry
CV4 7AL
United Kingdom
CV4 7AL
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
| Phone | +44 (0)1132 545 843 |
|---|---|
| Sheila.Greener@doh.gsi.gov.uk | |
| Website | http://www.dh.gov.uk/en/index.htm |
"ROR" |
https://ror.org/03sbpja79 |
Funders
Funder type
Government
NIHR Health Technology Assessment Programme - HTA (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 22/02/2007 | Yes | No | |
| Results article | results | 13/03/2010 | Yes | No | |
| Other publications | description of development of intervention | 01/06/2010 | Yes | No | |
| Results article | results | 01/09/2011 | Yes | No | |
| Results article | results | 01/02/2012 | Yes | No | |
| Results article | results | 14/01/2014 | Yes | No |
