Lumbar supports for home care workers with low back pain, an efficacy study
| ISRCTN | ISRCTN73707379 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73707379 |
| Secondary identifying numbers | N/A |
- Submission date
- 05/12/2005
- Registration date
- 05/12/2005
- Last edited
- 06/04/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof B.W. Koes
Scientific
Scientific
Erasmus Medical Center
Department of General Practice
P.O. Box 1738
Rotterdam
3000 DR
Netherlands
| Phone | +31 (0)10 4087620 |
|---|---|
| b.koes@erasmusmc.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Results of a systematic review showed that lumbar supports are not effective in the primary prevention of Low Back Pain (LBP), but there were positive indications for the secondary preventive use of lumbar supports in the reduction of low back pain. In this randomised controlled trial (RCT) we study the secondary preventive efficacy of these lumbar supports. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Low back pain (LBP) |
| Intervention | 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). |
| Intervention type | Other |
| Primary outcome measure | 1. Number of days low back pain per month 2. Number of days sick leave per year (calendar days) 3. Cost effectiveness |
| Secondary outcome measures | 1. Severity of experienced low back pain (11 point NRS) 2. Functional status (Quebec Back Pain Disability Scale) 3. Compliance |
| Overall study start date | 01/05/2003 |
| Completion date | 30/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 360 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2003 |
| Date of final enrolment | 30/12/2004 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Center
Rotterdam
3000 DR
Netherlands
3000 DR
Netherlands
Sponsor information
Erasmus Medical Center (The Netherlands) - Department of General Practice
University/education
University/education
P.O. Box 1738
Rotterdam
3000 DR
Netherlands
"ROR" |
https://ror.org/018906e22 |
|---|
Funders
Funder type
Research organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
No information available
Results and Publications
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2002 | Yes | No | |
| Results article | results | 20/11/2007 | Yes | No | |
| Results article | results | 15/12/2010 | Yes | No |
