Back PainNCT00463216
A Coordinated Return to Work Program
A study testing A multidisciplinary diagnostic evaluation in people with Back Pain, run by Vejle Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Back Pain
- What is being tested?
- A multidisciplinary diagnostic evaluation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2004to Apr 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- On sick leave due to back,
- Shoulder or neck pain
Who cannot join
- Pregnant,
- Other causes of sick leave
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Coordinated Return to Work Program for Workers on Long-term Sickness Absence Due to Musculoskeletal Disorders: a Prospective Controlled Intervention Study
The aim of the study is to investigate the possibility that a diagnostic evaluation by a multidisciplinary team reduces the length of sick leave.
Read the 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"
- Conditions
- Back Pain
- Being tested
- A multidisciplinary diagnostic evaluation
- Keywords
- back, neck, pain, sick leave
- Medical subject headings
- Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A multidisciplinary diagnostic evaluationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hours on sick leave in the 1 year study period
Secondary outcomes (1)
Sick leave related costs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2007 (estimated)
- Study startApr 2004
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jorgen Kilsgaard, chiropract, Principal investigator, Vejle County, Vejle, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00463216
- Sponsor's protocol ID
- F03-05
- Status last verified
- Mar 2007
- First submitted
- 18 Apr 2007
- Last updated
- 8 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Coordinated Return to Work Program for Workers on Long-term Sickness Absence Due to Musculoskeletal Disorders: a Prospective Controlled Intervention Study
- ClinicalTrials.gov ID
- NCT00463216
- Acronym / sponsor ID
- F03-05
- Conditions
- Back Pain
- Keywords
- back, neck, pain, sick leave
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- Apr 2004
- Study completion
- Apr 2006
- First posted
- 20 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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"
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- On sick leave due to back,
- Shoulder or neck pain
Key exclusion criteria (2 listed)
- Pregnant,
- Other causes of sick leave
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A multidisciplinary diagnostic evaluation | Behavioural | – |
Primary outcome
Number of hours on sick leave in the 1 year study period
1 secondary outcome
Sick leave related costs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorgen Kilsgaard, chiropract principal investigator
Vejle County, Vejle, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A multidisciplinary diagnostic evaluation in people with Back Pain, run by Vejle Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of hours on sick leave in the 1 year study period. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2010.