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| [ Print-friendly version ] |
| The UK Back pain, Exercise Active management and Manipulation trial |
| ISRCTN | ISRCTN32683578 |
| DOI | 10.1186/ISRCTN32683578 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | The UK Back pain, Exercise Active management and Manipulation trial |
| Scientific title | |
| Acronym | UK BEAM |
| Serial number at source | G9628230 |
| Study hypothesis | To evaluate the effectiveness of different physical interventions for back pain in primary care. |
| Lay summary | |
| Ethics approval | Not provided at time of registration |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Primary care |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/09/1997 |
| Anticipated end date | 30/04/2001 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 1350 |
| Interventions |
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. |
| Primary outcome measure(s) | 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 measure(s) | Not provided at time of registration |
| Sources of funding | Medical Research Council (UK) |
| Trial website | |
| Publications |
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 |
| Contact name | Mr Simon Coulton |
| Address |
University of Kent
Centre for Health Services Studies (CHSS) George Allen Wing Cornwallis Building Canterbury |
| City/town | Kent |
| Zip/Postcode | CT2 7NF |
| Country | United Kingdom |
| s.coulton@kent.ac.uk | |
| Sponsor | Medical Research Council (UK) |
| Address | 20 Park Crescent |
| City/town | London |
| Zip/Postcode | W1B 1AL |
| Country | United Kingdom |
| Tel | +44 (0)20 7636 5422 |
| Fax | +44 (0)20 7436 6179 |
| clinical.trial@headoffice.mrc.ac.uk | |
| Sponsor website: | http://www.mrc.ac.uk |
| Date applied | 23/10/2000 |
| Last edited | 06/07/2009 |
| Date ISRCTN assigned | 23/10/2000 |
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