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Sponsored by: |
Vejle Hospital |
---|---|
Information provided by: | Vejle Hospital |
ClinicalTrials.gov Identifier: | NCT00463216 |
The aim of the study is to investigate the possibility that a diagnostic evaluation by a multidisciplinary team reduces the length of sick leave.
Condition | Intervention |
---|---|
Back Pain |
Behavioral: A multidisciplinary diagnostic evaluation |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Open Label, Placebo Control, Parallel Assignment |
Official Title: | A Coordinated Return to Work Program for Workers on Long-Term Sickness Absence Due to Musculoskeletal Disorders: a Prospective Controlled Intervention Study |
Estimated Enrollment: | 120 |
Study Start Date: | April 2004 |
Estimated Study Completion Date: | April 2006 |
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"
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | F03-05 |
Study First Received: | April 18, 2007 |
Last Updated: | April 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00463216 |
Health Authority: | Denmark: The Regional Committee on Biomedical Research Ethics |
back, neck, pain, sick leave |
Signs and Symptoms Musculoskeletal Diseases Neurologic Manifestations Pain Back Pain |
Nervous System Diseases |