| - candidate number | 1854 |
| - NTR Number | NTR510 |
| - ISRCTN | ISRCTN73707379 |
| - Date ISRCTN created | 5-dec-2005 |
| - date ISRCTN requested | 2-dec-2005 |
| - Date Registered NTR | 25-nov-2005 |
| - Secondary IDs | N/A |
| - Public Title | Lumbar supports for home care workers with low back pain, an efficacy study. |
| - Scientific Title | Lumbar supports for home care workers with low back pain, an efficacy study. |
| - ACRONYM | N/A |
| - hypothesis | Results of a systematic review showed that lumbar supports are not effective in the primary prevention of low back pain, but there were positive indications for the secondary preventive use of lumbar supports in the reduction of low back pain. In this RCT we study the secondary preventive efficacy of these lumbar supports. |
| - Healt Condition(s) or Problem(s) studied | Low back pain (LBP) |
| - Inclusion criteria | 1. Reporting LBP at the start of the study, or reporting two or more episodes of LBP in the 12 months prior to the start of the study; 2. Performing medical care and/or domestic tasks as a home care worker. |
| - Exclusion criteria | 1. Suffering from specific LBP e.g. rheumatoid arthritis or vertebral fractions; 2. Pregnant at the start of the study; 3. Receiving medical treatment for high blood pressure. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | Single |
| - control | Active |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-mei-2003 |
| - planned closingdate | 30-nov-2004 |
| - Target number of participants | 360 |
| - Interventions | A lumbar support was provided to the intervention group in addition to usual care (primary and secondary care for the management of LBP, available as usual). |
| - Primary outcome | 1. Number of days low back pain per month; 2. Number of days sick leave per year (calendar days); 3. Cost effectiveness. |
| - Secondary outcome | 1. Severity of experienced low back pain (11 point NRS); 2. Functional status (Quebec Back Pain Disability Scale); 3. Compliance. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | stopped: trial finished |
| - CONTACT FOR PUBLIC QUERIES | Prof. dr. B.W. Koes |
| - CONTACT for SCIENTIFIC QUERIES | MSc. P.D.D.M. Roelofs |
| - Sponsor/Initiator | Erasmus Medical Center, Department of General Practice |
| - Funding (Source(s) of Monetary or Material Support) | ZON-MW, The Netherlands Organization for Health Research and Development |
| - Publications | 1. Jellema P, Bierma-Zeinstra SM, Van Poppel MN, Bernsen RM, Koes BW. Feasibility of lumbar supports for home care workers with low back pain. Occup Med (Lond) 2002; 52:317-23. 2. Ann Intern Med. 2007 Nov 20;147(10):685-92. |
| - Brief summary | LBP is a major problem among home care workers. Annual prevalences range from 44-72%. There are indications of positive effects, when using a lumbar support as a secondary preventive measure against LBP. This RCT studies the efficacy of using lumbar supports in the secondary prevention of LBP among home care workers. |
| - Main changes (audit trail) | |
| - RECORD | 25-nov-2005 - 16-jun-2008 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl