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11 February 2012
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| [ Print-friendly version ] |
| The Sherbrooke Model |
| ISRCTN | ISRCTN60233560 |
| ClinicalTrials.gov identifier | |
| Public title | The Sherbrooke Model |
| Scientific title | |
| Acronym | ASE |
| Serial number at source | 3140.0001 |
| Study hypothesis | A randomised controlled trial and cost-effectiveness evaluation in employees sick-listed for a period of 2 to 6 weeks due to low back pain. |
| Lay summary | |
| Ethics approval | The study design, protocols, procedures and informed consent form were approved by the Medical Ethics Committee of VU University Medical Centre, and all participants provided written, informed consent. |
| Study design | Randomised controlled trial |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | Non specific low back pain |
| Participants - inclusion criteria | Workers on sick leave for 2 to 6 weeks due to non specific low back pain. |
| Participants - exclusion criteria |
1. Specific causes of low back pain:
1.1. Herniated discs with pareses 1.2. Paralysis 1.3. Spinal tumour 1.4. Spinal fracture 1.5. Ankylosing spondilitis 1.6. Spinal stenosis 1.7. Spondylolisthesis 1.8. Specific rheumatological diseases 1.9. Pregnancy 2. Serious psychiatric disorders 3. Legal conflict at work 4. Sick-listed due to low back pain less than one month prior to the current episode of sick leave |
| Anticipated start date | 01/01/1999 |
| Anticipated end date | 01/10/2002 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 200 |
| Interventions |
1. Participatory ergonomics
2. Graded activity 3. Usual care |
| Primary outcome measure(s) |
Return to work.
Outcome measures are assessed before randomisation (after 2 - 6 weeks on sick leave) and 12 weeks, 26 weeks and 52 weeks after first day of sick leave. |
| Secondary outcome measure(s) |
Secondary outcome measures:
1. Pain intensity 2. Functional status 3. General improvement Intermediate variables: 1. Kinesiophobia 2. Pain coping Cost-effectiveness analysis: 1. Direct and indirect costs due to low back pain Outcome measures are assessed before randomisation (after 2 - 6 weeks on sick leave) and 12 weeks, 26 weeks and 52 weeks after first day of sick leave. |
| Sources of funding |
1. The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) (ref: 3140.0001)
2. Dutch Ministries of Health, Welfare and Sports and of Social Affairs (The Netherlands) |
| Trial website | |
| Publications |
1. 2003 protocol in http://www.ncbi.nlm.nih.gov/pubmed/14629775
2. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17268258 3. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19412140 |
| Contact name | Prof Willem Van Mechelen |
| Address | van der Boechorststraat 7 |
| City/town | Amsterdam |
| Zip/Postcode | 1081 BT |
| Country | Netherlands |
| Tel | +31 (0)20 444 8410 |
| Fax | +31 (0)20 444 8387 |
| w.van_mechelen.emgo@med.vu.nl | |
| Sponsor | The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) |
| Address |
Laan van Nieuw Oost Indië 334
P.O. Box 93245 |
| City/town | The Hague |
| Zip/Postcode | 2509 AE |
| Country | Netherlands |
| Tel | +31 (0)70 349 51 11 |
| Fax | +31 (0)70 349 51 00 |
| info@zonmw.nl | |
| Date applied | 21/08/2003 |
| Last edited | 30/06/2009 |
| Date ISRCTN assigned | 22/08/2003 |
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| © 2012 ISRCTN unless otherwise stated. | |
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