- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00463216
A Coordinated Return to Work Program
A Coordinated Return to Work Program for Workers on Long-term Sickness Absence Due to Musculoskeletal Disorders: a Prospective Controlled Intervention Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Workers on sick leave due to back, neck or shoulder pain are randomized into 2 groups. Individuals in the intervention group are offered an extra multidisciplinary diagnostic evaluation. The multidisciplinary team consists of an occupational physician, a physiotherapist, a chiropractor, a psychologist and a social worker. The result is a coordinated evaluation of the individuals problems with suggestions as to further actions. The focus is on evaluating, if and when the individual can return to work. No treatment is given.
Verbatim exemption from the local medical ethics board:
"February 19, 2004 Journal no. VF 20040030 JK/csf Re: research project: A Coordinated Return to Work Program (KIA) The The Medical Ethics Committee of Vejle and Funen Counties has reviewed this research project at its meeting on February 9, 2004.
The entire committee decided that this project is an HTA (Health Technology Assessment) study and not a biomedical research project.
Therefore the committee decided that the project is not within the committee's legal competence areas, and is exempt from approval by a medical ethics committee before being carried out.
The committee has no further comments to this case. on behalf of the committee Sincerely Erik Laier Jette Krarup
__________________________________________________________________________________________________________________________________________________
Odense University Hospital direct telephone: +45 6541 3425 Kløvervaenget 10, 2.sal e-mail: Vejle-fynkomiteen@ouh.fyns-amt.dk 5000 Odense C fax: +45 6619 4392 Denmark"
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Vejle, Denmark, 7100
- Dept Occup Environ Med, Vejle Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- On sick leave due to back,
- Shoulder or neck pain
Exclusion Criteria:
- Pregnant,
- Other causes of sick leave
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Number of hours on sick leave in the 1 year study period
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Secondary Outcome Measures
Outcome Measure |
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Sick leave related costs
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jorgen Kilsgaard, chiropract, Vejle County, Vejle, Denmark
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- F03-05
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