The UK Back pain, Exercise Active management and Manipulation trial

Completed

Conditions: Primary care
Musculoskeletal Diseases
Dorsalgia

Registration Number: ISRCTN32683578

Lead Sponsor: Medical Research Council (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 1350

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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