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Cost effectiveness of an occupational physical therapy programme on primary and secondary prevention of low back pain: economic evaluation alongside a cluster randomised controlled trial.


- candidate number1774
- NTR NumberNTR395
- ISRCTNISRCTN42542680
- Date ISRCTN created2-nov-2005
- date ISRCTN requested28-okt-2005
- Date Registered NTR19-okt-2005
- Secondary IDsN/A 
- Public TitleCost effectiveness of an occupational physical therapy programme on primary and secondary prevention of low back pain: economic evaluation alongside a cluster randomised controlled trial.
- Scientific TitleCost effectiveness of an occupational physical therapy programme on primary and secondary prevention of low back pain: economic evaluation alongside a cluster randomised controlled trial.
- ACRONYMN/A
- hypothesisWhat 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?
- Healt Condition(s) or Problem(s) studiedLow back pain (LBP)
- Inclusion criteriaThe study population is recruited from companies throughout The Netherlands. Companies who want to take up the programme from the occupational health consultance 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 participate in the study.
- Exclusion criteriaN/A
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-jan-2001
- planned closingdate15-aug-2005
- Target number of participants500
- InterventionsThe 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 company’s 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.
- Primary outcomeThe primary outcome measure is the occurrence and duration of LBP and subsequent sickness absence.
- Secondary outcomeSecondary 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.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES W. IJzelenberg
- CONTACT for SCIENTIFIC QUERIES A. Burdorf
- Sponsor/Initiator Erasmus Medical Center, Department of Public Health
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsSpine. 2007 Apr 1;32(7):711-9.
- Brief summaryLBP accounts for high economical costs in Western societies. Little is known on cost-effectiveness of prevention programmes for LBP. Our objective is to evaluate the effectiveness and cost-effectiveness of a physical therapy programme on primary and secondary prevention of low back pain compared to usual care in an occupational setting. We therefore will perform a cluster randomised controlled trial and full economic evaluation with 12 months follow-up, with the work-unit as the unit of randomization. Companies who want to take up the programme from the occupational health consultance that executes the intervention under study within a year, are asked to participate in the study. In each company 2 work units are allocated at random to the intervention group or the usual care group. All workers in the allocated work units who work at least 3 days a week are asked to participate in the study. The physical therapy programme consists of an integrated approach of a primary prevention programme, including counseling and ergonomic training of working techniques/ skillls tailored for each company’s specific work-site aimed at preventing back complaints, and a secondary prevention programme that consisted of a quick intervention with easy accessible incompany physical therapy in the origin of (absenteeism due to) back complaints. Usual care is provided by the general prartitioner or occupational physician according to Dutch health care guidelines. The primary outcome measure are the occurrence and duration of LBP and subsequent sickness absence. 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 included both direct and indirect costs due to LBP.
- Main changes (audit trail)
- RECORD19-okt-2005 - 5-sep-2008


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