Condition category
Musculoskeletal Diseases
Date applied
23/10/2000
Date assigned
23/10/2000
Last edited
06/07/2009
Prospective/Retrospective
Retrospectively 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

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 measures

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

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

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Additional files

Editorial Notes