Return to WorkNCT03010384
Contact to a Physician Specialized in Social Medicine and Return to Work
A study testing Rehabilitation program in people with Return to Work and Musculoskeletal Disease, run by Kirsten Fonager.
Trial summary
The aim of this study was to investigate the impact of a rehabilitation program including a physician specialized in social medicine parallel to treatment for suspected spinal disc herniation. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Return to Work, Musculoskeletal Disease
- What is being tested?
- Rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 443 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Jul 2014
- 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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age ≥ 18 and < 60 years old,
- not receiving disability pension and not on maternity leave.
- sick leave over the past year for more than ten days
- low self-rated work ability for the next two years
- health anxiety
Who cannot join
- -
About this study
Official title: Contact to a Physician Specialized in Social Medicine and the Impact on Return to Workforce in Patients Suspected of Disc Herniation? - a Randomized Controlled Trial
The aim of this study was to investigate the impact of a rehabilitation program including a physician specialized in social medicine parallel to treatment for suspected spinal disc herniation.
Read the detailed description
In a two-year time period (2011 to 2012) 443 patients of suspected of disc herniation and risk of low work ability - based on questionnaires participated in a randomized control trial. The patients were randomized to either the intervention group (n=220) or control group (n=223). The intervention group were invited to the Department of Social Medicine two to four weeks after their first contact to Department of Rheumatology for a consultation with a physician specialized in social medicine. Together with the patient a return-to-work (RTW) schedule was made to ascertain the need for contact to the workplace (to adjust work functions), municipality, general practitioner or short-term supportive consultations with a psychologist. Throughout the intervention, the patients received their usual treatment from the Department of Rheumatology like patients from the control group. Outcome was return to the work force at one year follow up using information from a national registry.
- Conditions
- Return to Work, Musculoskeletal Disease
- Being tested
- Rehabilitation program
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation programOther
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Consultation with a physician specialized in social medicine. The consultation lasted about one hour. Together with the patient a return-to-work (RTW) schedule was made to ascertain the need for contact to the workplace (to adjust work functions), municipality, general practitioner or short-term supportive consultations with a psychologist. If relevant, patients were offered up till 5 sessions with a psychologist. Receives: Other: Rehabilitation program |
| Control | No intervention | Standard treatment from the Department of Rheumatology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to Work (register based information)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startJan 2011
- Primary completionDec 2012
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Return to WorkStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 443 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsten Fonager
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kirsten Fonager, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010384
- Sponsor's protocol ID
- Reuma-2011
- Status last verified
- Jan 2017
- First submitted
- 6 Dec 2016
- Last updated
- 5 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contact to a Physician Specialized in Social Medicine and the Impact on Return to Workforce in Patients Suspected of Disc Herniation? - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03010384
- Acronym / sponsor ID
- Reuma-2011
- Conditions
- Return to Work, Musculoskeletal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 443 participants (actual)
- Lead sponsor
- Kirsten FonagerUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 5 Jan 2017 (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 this study was to investigate the impact of a rehabilitation program including a physician specialized in social medicine parallel to treatment for suspected spinal disc herniation.
Detailed description
In a two-year time period (2011 to 2012) 443 patients of suspected of disc herniation and risk of low work ability - based on questionnaires participated in a randomized control trial. The patients were randomized to either the intervention group (n=220) or control group (n=223). The intervention group were invited to the Department of Social Medicine two to four weeks after their first contact to Department of Rheumatology for a consultation with a physician specialized in social medicine. Together with the patient a return-to-work (RTW) schedule was made to ascertain the need for contact to the workplace (to adjust work functions), municipality, general practitioner or short-term supportive consultations with a psychologist. Throughout the intervention, the patients received their usual treatment from the Department of Rheumatology like patients from the control group. Outcome was return to the work force at one year follow up using information from a national registry.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Other: Rehabilitation programConsultation with a physician specialized in social medicine. The consultation lasted about one hour. Together with the patient a return-to-work (RTW) schedule was made to ascertain the need for contact to the workplace (to adjust work functions), municipality, general practitioner or short-term supportive consultations with a psychologist. If relevant, patients were offered up till 5 sessions with a psychologist. |
| Control | No intervention | –Standard treatment from the Department of Rheumatology |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- age ≥ 18 and < 60 years old,
- not receiving disability pension and not on maternity leave.
- sick leave over the past year for more than ten days
- low self-rated work ability for the next two years
- health anxiety
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Rehabilitation program | Other | Intervention |
Primary outcome
Return to Work (register based information)
Time frame: one year
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 5 Jan 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation program in people with Return to Work and Musculoskeletal Disease, run by Kirsten Fonager.
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 5 inclusion and 1 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 5 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Return to Work (register based information) (time frame: one year). 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 5 Jan 2017.