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
Protocol serial number	HTA 01/75/01
Sponsor	Department of Health (UK)
Funder	NIHR Health Technology Assessment Programme - HTA (UK)

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

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
Email	s.lamb@warwick.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(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
Key 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
Completion date	05/10/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Centre for Primary Health Care Studies

Coventry
CV4 7AL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	13/03/2010	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
Protocol article	protocol	22/02/2007	Yes	No
Other publications	description of development of intervention	01/06/2010	Yes	No