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Lumbar supports for home care workers with low back pain, an efficacy study
ISRCTN ISRCTN73707379
DOI 10.1186/ISRCTN73707379
ClinicalTrials.gov identifier
EudraCT number
Public title Lumbar supports for home care workers with low back pain, an efficacy study
Scientific title
Acronym N/A
Serial number at source N/A
Study hypothesis 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.
Lay summary
Ethics approval Ethics approval received from the local medical ethics committee
Study design Randomised controlled trial
Countries of recruitment Netherlands
Disease/condition/study domain Low back pain (LBP)
Participants - 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
Participants - 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
Anticipated start date 01/05/2003
Anticipated end date 30/12/2004
Status of trial Completed
Patient information material
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 measure(s) 1. Number of days low back pain per month
2. Number of days sick leave per year (calendar days)
3. Cost effectiveness
Secondary outcome measure(s) 1. Severity of experienced low back pain (11 point NRS)
2. Functional status (Quebec Back Pain Disability Scale)
3. Compliance
Sources of funding The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Trial website
Publications 1. 2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12361993
2. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/18025444
3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20823783
Contact name Prof  B.W.  Koes
  Address Erasmus Medical Center
Department of General Practice
P.O. Box 1738
  City/town Rotterdam
  Zip/Postcode 3000 DR
  Country Netherlands
  Tel +31 (0)10 4087620
  Email b.koes@erasmusmc.nl
Sponsor Erasmus Medical Center (The Netherlands) - Department of General Practice
  Address P.O. Box 1738
  City/town Rotterdam
  Zip/Postcode 3000 DR
  Country Netherlands
Date applied 05/12/2005
Last edited 06/04/2011
Date ISRCTN assigned 05/12/2005
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