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A Coordinated Return to Work Program

This study has been completed.
Sponsor:
Information provided by:
Vejle Hospital
ClinicalTrials.gov Identifier:
NCT00463216
First received: April 18, 2007
Last updated: February 5, 2010
Last verified: March 2007
History of Changes
  Purpose

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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Coordinated Return to Work Program for Workers on Long-term Sickness Absence Due to Musculoskeletal Disorders: a Prospective Controlled Intervention Study

Resource links provided by NLM:

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Further study details as provided by Vejle Hospital:

Primary Outcome Measures:
  • Number of hours on sick leave in the 1 year study period

Secondary Outcome Measures:
  • Sick leave related costs

Estimated Enrollment: 120
Study Start Date: April 2004
Estimated Study Completion Date: April 2006
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"

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • On sick leave due to back,
  • Shoulder or neck pain

Exclusion Criteria:

  • Pregnant,
  • Other causes of sick leave
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00463216

Locations
Denmark
Dept Occup Environ Med, Vejle Hospital
Vejle, Denmark, 7100
Sponsors and Collaborators
Vejle Hospital
Investigators
Principal Investigator: Jorgen Kilsgaard, chiropract Vejle County, Vejle, Denmark
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00463216     History of Changes
Other Study ID Numbers: F03-05
Study First Received: April 18, 2007
Last Updated: February 5, 2010
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Vejle Hospital:
back, neck, pain, sick leave

Additional relevant MeSH terms:
Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013