The UK Back pain, Exercise Active management and Manipulation trial

ISRCTN	ISRCTN32683578
DOI	https://doi.org/10.1186/ISRCTN32683578
Secondary identifying numbers	G9628230

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Simon Coulton
Scientific

University of Kent
Centre for Health Services Studies (CHSS)
George Allen Wing
Cornwallis Building
Canterbury
Kent
CT2 7NF
United Kingdom

Email	s.coulton@kent.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study acronym	UK BEAM
Study objectives	To evaluate the effectiveness of different physical interventions for back pain in primary care.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
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 study start date	01/09/1997
Completion date	30/04/2001

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	Both
Target number of participants	1350
Key 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
Key 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
Date of first enrolment	01/09/1997
Date of final enrolment	30/04/2001

University of Kent

Kent
CT2 7NF
United Kingdom

Medical Research Council (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone	+44 (0)20 7636 5422
Email	clinical.trial@headoffice.mrc.ac.uk
Website	http://www.mrc.ac.uk

Research council

Medical Research Council (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

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

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	01/08/2003	Yes	No
Results article	results on cost effectiveness	11/12/2004	Yes	No
Results article	results on effectiveness	11/12/2004	Yes	No
Results article	results	01/06/2006	Yes	No
Results article	results	11/06/2009	Yes	No