Contact information
Type
Scientific
Primary contact
Mr Simon Coulton
ORCID ID
Contact details
University of Kent
Centre for Health Services Studies (CHSS)
George Allen Wing
Cornwallis Building
Canterbury
Kent
CT2 7NF
United Kingdom
s.coulton@kent.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G9628230
Study information
Scientific title
Acronym
UK BEAM
Study hypothesis
To evaluate the effectiveness of different physical interventions for back pain in primary care.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Primary care
Intervention
General practices randomised between:
I. An active management training programme and conventional management
Patients within practices randomised between:
II. A spinal manipulation package agreed recently by representatives of the chiropractic, osteopathy and physiotherapy professions and delivered in private premises, the same package delivered in NHS premises and conventional management
III. A promising progressive exercise package supported by representatives of the physiotherapy profession and conventional management
Please note that, as of 14/02/2007, the anticipated end date of this trial has been updated to 31/08/2004.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
The primary outcome measure is the change in Roland Disability Questionnaire (RDQ) score at 3 and 12 months. A change of 2.5 points on the scale has been agreed by the UK BEAM Working Party and Trial Steering Committee as clinically significant.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/1997
Overall trial end date
30/04/2001
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Primary care back pain consultors aged between 18 and 65 years
2. Non-specific back pain
3. Referred leg pain must be predominantly above knee
4. Fluent in English - able to read and write
5. No physical therapies in previous 3 months
6. Duration at least 4 weeks
7. Roland Disability Questionnaire (RDQ) score of 4 or more
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1350
Participant exclusion criteria
1. People over 65
2. Clinical indications for the investigation of possible serious spinal or neurological pathology, or for urgent surgical referral
3. Nerve root pain
4. Previous spinal surgery
5. Major psychological complication or abnormal illness behaviour, referred to a tertiary pain management programme
6. Other musculoskeletal disorders which would interfere with therapy
7. History of psychosis or major alcohol abuse
8. Other concurrent medical conditions, including cardiovascular disease
9. Moderate to severe hypertension
10. Long-term steroid use
11. Anti-coagulant therapy
12. Perceived inability to walk 100 metres when free of pain
13. Unable to get up and down off floor unaided
14. Physical therapy (including acupuncture) in the previous 3 months
15. Unable to read and write fluently in English
16. Roland Disability questionnaire score of 3 or less on the day of randomisation
Recruitment start date
01/09/1997
Recruitment end date
30/04/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Kent
Kent
CT2 7NF
United Kingdom
Sponsor information
Organisation
Medical Research Council (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
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
Basic results (scientific)
Publication list
1. 2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12892566
2. 2004 results on effectiveness in http://www.ncbi.nlm.nih.gov/pubmed/15556955
3. 2004 results on cost effectiveness in http://www.ncbi.nlm.nih.gov/pubmed/15556954
4. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16418201
5. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19519911
Publication citations
-
Results
Underwood MR, Harding G, Klaber Moffett J, , Patient perceptions of physical therapy within a trial for back pain treatments (UK BEAM) [ISRCTN32683578]., Rheumatology (Oxford), 2006, 45, 6, 751-756, doi: 10.1093/rheumatology/kei254.
-
Results
Froud R, Eldridge S, Lall R, Underwood M, Estimating the number needed to treat from continuous outcomes in randomised controlled trials: methodological challenges and worked example using data from the UK Back Pain Exercise and Manipulation (BEAM) trial., BMC Med Res Methodol, 2009, 9, 35, doi: 10.1186/1471-2288-9-35.
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Brealey S, Burton K, Coulton S, Farrin A, Garratt A, Harvey E, Letley L, Martin J, Klaber MJ, Russell I, Torgerson D, Underwood M, Vickers M, Whyte K, Williams M, , UK Back pain Exercise And Manipulation (UK BEAM) trial--national randomised trial of physical treatments for back pain in primary care: objectives, design and interventions [ISRCTN32683578]., BMC Health Serv Res, 2003, 3, 1, 16, doi: 10.1186/1472-6963-3-16.
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United Kingdom back pain exercise and manipulation (UK BEAM) randomised trial: effectiveness of physical treatments for back pain in primary care., BMJ, 2004, 329, 7479, 1377, doi: 10.1136/bmj.38282.669225.AE.
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United Kingdom back pain exercise and manipulation (UK BEAM) randomised trial: cost effectiveness of physical treatments for back pain in primary care., BMJ, 2004, 329, 7479, 1381, doi: 10.1136/bmj.38282.607859.AE.