Contact information
Type
Scientific
Primary contact
Dr W. IJzelenberg
ORCID ID
Contact details
Erasmus Medical Center Rotterdam
Department of Public Health
P.O. Box 1738
Rotterdam
3000 DR
Netherlands
+31 (0)10 4087718
w.ijzelenberg@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR395
Study information
Scientific title
Acronym
Study hypothesis
What is the cost-effectiveness of a back training programme consisting of a combination of three parts: counselling and training to prevent back complaints, analysis and ergonomic adaptation of the work station, and quick intervention in the origin of (absenteeism due to) back complaints?
Ethics approval
Received from a local medical ethics committee
Study design
Economic evaluation alongside a cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Low back pain (LBP)
Intervention
The physical therapy programme consists of an integrated approach of a primary prevention programme, including counselling and ergonomic training of working techniques/skills tailored for each companys specific work-site aimed at preventing back complaints, and a secondary prevention programme that consisted of a quick intervention with easy accessible in-company physical therapy in the origin of (absenteeism due to) back complaints.
Usual care is provided by the general practitioner or occupational physician according to Dutch health care guidelines.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The primary outcome measure is the occurrence and duration of LBP and subsequent sickness absence.
Secondary outcome measures
Secondary outcome measures are pain intensity, functional disability due to low back pain complaints, general health and quality of life. The economic evaluation is conducted from a societal perspective and includes both direct and indirect costs due to LBP.
Overall trial start date
15/01/2001
Overall trial end date
15/08/2005
Reason abandoned
Eligibility
Participant inclusion criteria
The study population is recruited from companies throughout the Netherlands. Companies who want to take up the programme from the occupational health consultancy that executes the intervention under study within a year are asked to participate in the study.
Inclusion criteria for companies are:
1. Willingness to participate in the study
2. The possibility of forming a control group within the same company with workers with approximately the same physically demanding jobs and high prevalence of musculoskeletal complaints
3. Willingness to concur with randomisation of the intervention and study protocol.
Inclusion criteria for workers:
All workers in the work units of these companies who are working at least 3 days per week, are willing to comply with the research protocol and follow-up measurements are asked to participate in the study.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
500
Participant exclusion criteria
Does not comply with the above inclusion criteria
Recruitment start date
15/01/2001
Recruitment end date
15/08/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Center Rotterdam
Rotterdam
3000 DR
Netherlands
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17414902
Publication citations
-
Results
IJzelenberg H, Meerding WJ, Burdorf A, Effectiveness of a back pain prevention program: a cluster randomized controlled trial in an occupational setting., Spine, 2007, 32, 7, 711-719, doi: 10.1097/01.brs.0000259072.14859.d9.