Condition category
Musculoskeletal Diseases
Date applied
17/09/2003
Date assigned
23/09/2003
Last edited
30/09/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Sarah Elizabeth Lamb

ORCID ID

Contact details

Centre for Primary Health Care Studies
University of Warwick
Room 104
Avon Building
Westwood Campus
Coventry
CV4 7AL
United Kingdom
+44 024 7657 4657
s.lamb@warwick.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 01/75/01

Study information

Scientific title

Acronym

UK-BeST

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.

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

West Midlands Multi-Centred Research Ethics Committee, Birmingham UK (MRC/03/7/04) provided the ethical review and approval.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

06/10/2003

Overall trial end date

05/10/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

700

Participant exclusion criteria

Exclusions will be based on pre-specified factors associated with serious pathologies.

Recruitment start date

06/10/2003

Recruitment end date

05/10/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Primary Health Care Studies
Coventry
CV4 7AL
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2007 protocol http://www.ncbi.nlm.nih.gov/pubmed/17316434
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20189241
3. 2010 description of development of intervention in http://www.ncbi.nlm.nih.gov/pubmed/20420955
4. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21820538
5. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22226729
6. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24423146

Publication citations

  1. Protocol

    Lamb SE, Lall R, Hansen Z, Withers EJ, Griffiths FE, Szczepura A, Barlow J, Underwood MR, , Design considerations in a clinical trial of a cognitive behavioural intervention for the management of low back pain in primary care: Back Skills Training Trial., BMC Musculoskelet Disord, 2007, 8, 14, doi: 10.1186/1471-2474-8-14.

  2. Results

    Lamb SE, Hansen Z, Lall R, Castelnuovo E, Withers EJ, Nichols V, Potter R, Underwood MR, , Group cognitive behavioural treatment for low-back pain in primary care: a randomised controlled trial and cost-effectiveness analysis., Lancet, 2010, 375, 9718, 916-923, doi: 10.1016/S0140-6736(09)62164-4.

  3. Description of development of intervention

    Hansen Z, Daykin A, Lamb SE, A cognitive-behavioural programme for the management of low back pain in primary care: a description and justification of the intervention used in the Back Skills Training Trial (BeST; ISRCTN 54717854)., Physiotherapy, 2010, 96, 2, 87-94, doi: 10.1016/j.physio.2009.09.008.

  4. Results

    Nichols VP, Griffiths FE, McCarthy CJ, Lamb SE, Exploring the use of the 'Adapted Miracle Question' in the assessment of low back pain., Physiotherapy, 2011, 97, 3, 203-208, doi: 10.1016/j.physio.2010.11.003.

  5. Results

    Lamb SE, Mistry D, Lall R, Hansen Z, Evans D, Withers EJ, Underwood MR, , Group cognitive behavioural interventions for low back pain in primary care: extended follow-up of the Back Skills Training Trial (ISRCTN54717854)., Pain, 2012, 153, 2, 494-501, doi: 10.1016/j.pain.2011.11.016.

  6. Results

    Knox CR, Lall R, Hansen Z, Lamb SE, Treatment compliance and effectiveness of a cognitive behavioural intervention for low back pain: a complier average causal effect approach to the BeST data set., BMC Musculoskelet Disord, 2014, 15, 17, doi: 10.1186/1471-2474-15-17.

Additional files

Editorial Notes