A Coordinated Return to Work Program
Primary Purpose
Back Pain
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
A multidisciplinary diagnostic evaluation
Sponsored by
About this trial
This is an interventional diagnostic trial for Back Pain focused on measuring back, neck, pain, sick leave
Eligibility Criteria
Inclusion Criteria:
- On sick leave due to back,
- Shoulder or neck pain
Exclusion Criteria:
- Pregnant,
- Other causes of sick leave
Sites / Locations
- Dept Occup Environ Med, Vejle Hospital
Outcomes
Primary Outcome Measures
Number of hours on sick leave in the 1 year study period
Secondary Outcome Measures
Sick leave related costs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00463216
Brief Title
A Coordinated Return to Work Program
Official Title
A Coordinated Return to Work Program for Workers on Long-term Sickness Absence Due to Musculoskeletal Disorders: a Prospective Controlled Intervention Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Vejle Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to investigate the possibility that a diagnostic evaluation by a multidisciplinary team reduces the length of sick leave.
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"
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain
Keywords
back, neck, pain, sick leave
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
A multidisciplinary diagnostic evaluation
Primary Outcome Measure Information:
Title
Number of hours on sick leave in the 1 year study period
Secondary Outcome Measure Information:
Title
Sick leave related costs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
On sick leave due to back,
Shoulder or neck pain
Exclusion Criteria:
Pregnant,
Other causes of sick leave
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorgen Kilsgaard, chiropract
Organizational Affiliation
Vejle County, Vejle, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept Occup Environ Med, Vejle Hospital
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
A Coordinated Return to Work Program
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