Fibromyalgia, SecondaryNCT03535454
Work-Related Fibromyalgia
An observational study of Fibromyalgia, Secondary, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
The research is about fibromyalgia prevalency in working population and searching work-related fibromyalgia. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Secondary
- What is being tested?
- working hours
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2018to 11 Oct 2018
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Working woman
Who may be able to join
- working at least 3 months in same working place
Who cannot join
- Diagnosed with the other musculoskeletal diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa Taksim Research and Education Hospital
Istanbul
About this study
The research is about fibromyalgia prevalency in working population and searching work-related fibromyalgia.
Read the detailed description
4 different job population will be included in the study. Totally 200 people wil be included and evaluated. All participants will be women. The investigators will diagnose fibromyalgia with 2016 updated diagnostic criteria and evaluate work related musculoskeletal pain with nordic musculoskeletal questionnaire.
- Conditions
- Fibromyalgia, Secondary
- Being tested
- working hours
- Keywords
- Fibromyalgia, Musculoskeletal Diseases, Work
- Medical subject headings
- Fibromyalgia, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
working hoursOther
weekly working hours
| Study group | Role | What they receive |
|---|---|---|
| Factory workers | Not described Receives: Other: working hours | |
| Nurses | Not described Receives: Other: working hours | |
| Janitors | Not described Receives: Other: working hours | |
| Data automation employees | Not described Receives: Other: working hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
work related fibromyalgia
fibromyalgia in working population
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start1 Mar 2018
- Primary completion1 Sep 2018
- Study completion11 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia, SecondaryStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 110 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mehmet Akif GÜLER, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03535454
- Sponsor's protocol ID
- GaziosmanpasaTREH
- Status last verified
- Oct 2018
- First submitted
- 14 May 2018
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Work-Related Fibromyalgia
- ClinicalTrials.gov ID
- NCT03535454
- Acronym / sponsor ID
- GaziosmanpasaTREH
- Conditions
- Fibromyalgia, Secondary
- Keywords
- Fibromyalgia, Musculoskeletal Diseases, Work
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 11 Oct 2018 (actual)
- First posted
- 24 May 2018 (actual)
- 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 research is about fibromyalgia prevalency in working population and searching work-related fibromyalgia.
Detailed description
4 different job population will be included in the study. Totally 200 people wil be included and evaluated. All participants will be women. The investigators will diagnose fibromyalgia with 2016 updated diagnostic criteria and evaluate work related musculoskeletal pain with nordic musculoskeletal questionnaire.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Factory workers | – | Other: working hours |
| Nurses | – | Other: working hours |
| Janitors | – | Other: working hours |
| Data automation employees | – | Other: working hours |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Working woman
Key inclusion criteria (1 listed)
- working at least 3 months in same working place
Key exclusion criteria (1 listed)
- Diagnosed with the other musculoskeletal diseases
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 |
|---|---|---|
| working hoursweekly working hours | Other | Data automation employees, Factory workers, Janitors, Nurses |
Primary outcome
work related fibromyalgia
Time frame: 3 months
fibromyalgia in working population
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 12 Oct 2018.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, Secondary, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
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 1 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 12 Oct 2018. 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 Turkey (Türkiye). 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?
work related fibromyalgia (time frame: 3 months). 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 12 Oct 2018.