FibromyalgiaNCT03514056
Frequency of Fibromyalgia in Behcet Disease
An observational study of Fibromyalgia and Behcet Syndrome, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In various studies, the incidence of fibromyalgia in Behçet's patients is widely distributed. It was aimed to investigate the frequency and severity of fibromyalgia in Behcet disease in province Bursa. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fibromyalgia, Behcet Syndrome
- What is being tested?
- group 1:Patients diagnosed with Behcet disease and group 2: Patient diagnosed with fibromyalgia without Behcet disease
- How many people
- 146 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2018to 28 Feb 2019
- How long will I take part?
- 1 Day
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population consists of participants who are between age 18-75, not pregnant and who were not diagnosed previously with diabetes mellitus or chronic renal failure
Who may be able to join
- Patients diagnosed with Behcet disease according to international study group criteria
- Patients diagnosed with fibromyalgia according to classification criteria that were defined by the American Collage of Rheumatology in 2010 and updated in 2013
- Patients older than 18
- Patients younger than 75
Who cannot join
- Participants which were previously diagnosed with diabetes mellitus
- Participants which were previously diagnosed with chronic renal failure
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Yüksek İhtisas Education and Research Hospital
Bursa, 16230
About this study
Official title: Frequency of Fibromyalgia in Behcet Disease in Province Bursa
In various studies, the incidence of fibromyalgia in Behçet's patients is widely distributed. It was aimed to investigate the frequency and severity of fibromyalgia in Behcet disease in province Bursa.
Read the detailed description
There are few studies in the literature investigating the frequency of fibromyalgia in Behçet's disease. In various studies, the incidence of fibromyalgia in Behçet's disease was 5.7% -37.1%, which is widely distributed. There are no studies in literature comparing disease severity and pain thresholds at trigger points in fibromyalgia with and without Behcet's disease. In this study, it was aimed to investigate the frequency of fibromyalgia in Behcet's disease according to the criteria defined by the American Colloge of Rheuatology in 2010 and updated in 2013. It was also aimed to compare the severity of disease in fibromyalgia with and without Behcet's disease.
- Conditions
- Fibromyalgia, Behcet Syndrome
- Being tested
- group 1:Patients diagnosed with Behcet disease, group 2: Patient diagnosed with fibromyalgia without Behcet disease
- Keywords
- Fibromyalgia, Behcet Disease, Trigger points
- Medical subject headings
- Fibromyalgia, Behcet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group 1:Patients diagnosed with Behcet diseaseDiagnostic test
Frequency and severity of fibromyalgia will be investigated in patient diagnosed with Behcet disease
group 2: Patient diagnosed with fibromyalgia without Behcet diseaseDiagnostic test
Severity of fibromyalgia will be investigated in patient diagnosed with fibromyalgia
| Study group | Role | What they receive |
|---|---|---|
| 1 | group Behcet Receives: Diagnostic Test: group 1:Patients diagnosed with Behcet disease | |
| 2 | group fibromyalgia Receives: Diagnostic Test: group 2: Patient diagnosed with fibromyalgia without Behcet disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
fibromyalgia 2013 criteria
Fibromyalgia 2013 criteria were derived from the 10-item symptom score from the Symptom Impact Questionnaire (SIQR) symptoms and the 28-area pain location inventory (PLI). If the patients PLI score is above 17 (range 0-28) and an SIQR symptom score is above 21 (range 0-50), the participant will be diagnosed with fibromyalgia
Measured: Six months
Secondary outcomes (2)
Fibromyalgia impact questionnaire
The fibromyalgia impact questionnaire (FIQ) has 21 individual questions . All questions are based on an 11-point numeric rating scale of 0 to 10, with 10 being 'worst'. In the FIQ, all questions are framed in the context of the past 7 days. The total maximal score of the FIQ is 100.
Measured: Six days
Pain thresholds
Pain thresholds will be recorded by applying pressure to the 28 sensitive points until the participants demonstrate pain. Manual algometry device will be used to measure the pain threshold.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start30 May 2018
- Primary completion1 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 146 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Koray Ayar, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514056
- Sponsor's protocol ID
- 2011-KAEK-25 2018/03-14
- Status last verified
- Feb 2020
- First submitted
- 20 Apr 2018
- Last updated
- 25 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Fibromyalgia in Behcet Disease in Province Bursa
- ClinicalTrials.gov ID
- NCT03514056
- Acronym / sponsor ID
- 2011-KAEK-25 2018/03-14
- Conditions
- Fibromyalgia, Behcet Syndrome
- Keywords
- Fibromyalgia, Behcet Disease, Trigger points
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 30 May 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 2 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.
In various studies, the incidence of fibromyalgia in Behçet's patients is widely distributed. It was aimed to investigate the frequency and severity of fibromyalgia in Behcet disease in province Bursa.
Detailed description
There are few studies in the literature investigating the frequency of fibromyalgia in Behçet's disease. In various studies, the incidence of fibromyalgia in Behçet's disease was 5.7% -37.1%, which is widely distributed. There are no studies in literature comparing disease severity and pain thresholds at trigger points in fibromyalgia with and without Behcet's disease. In this study, it was aimed to investigate the frequency of fibromyalgia in Behcet's disease according to the criteria defined by the American Colloge of Rheuatology in 2010 and updated in 2013. It was also aimed to compare the severity of disease in fibromyalgia with and without Behcet's disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Diagnostic Test: group 1:Patients diagnosed with Behcet diseasegroup Behcet |
| 2 | – | Diagnostic Test: group 2: Patient diagnosed with fibromyalgia without Behcet diseasegroup fibromyalgia |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population consists of participants who are between age 18-75, not pregnant and who were not diagnosed previously with diabetes mellitus or chronic renal failure
Key inclusion criteria (4 listed)
- Patients diagnosed with Behcet disease according to international study group criteria
- Patients diagnosed with fibromyalgia according to classification criteria that were defined by the American Collage of Rheumatology in 2010 and updated in 2013
- Patients older than 18
- Patients younger than 75
Key exclusion criteria (3 listed)
- Participants which were previously diagnosed with diabetes mellitus
- Participants which were previously diagnosed with chronic renal failure
- Pregnant women
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 |
|---|---|---|
| group 1:Patients diagnosed with Behcet diseaseFrequency and severity of fibromyalgia will be investigated in patient diagnosed with Behcet disease | Diagnostic test | 1 |
| group 2: Patient diagnosed with fibromyalgia without Behcet diseaseSeverity of fibromyalgia will be investigated in patient diagnosed with fibromyalgia | Diagnostic test | 2 |
Primary outcome
fibromyalgia 2013 criteria
Time frame: Six months
Fibromyalgia 2013 criteria were derived from the 10-item symptom score from the Symptom Impact Questionnaire (SIQR) symptoms and the 28-area pain location inventory (PLI). If the patients PLI score is above 17 (range 0-28) and an SIQR symptom score is above 21 (range 0-50), the participant will be diagnosed with fibromyalgia
2 secondary outcomes
Fibromyalgia impact questionnaire
Time frame: Six days
Pain thresholds
Time frame: Six months
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 25 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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 and Behcet Syndrome, run by Bursa Yuksek Ihtisas Training and Research 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 4 inclusion and 3 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 25 Feb 2020. 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?
fibromyalgia 2013 criteria (time frame: Six 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 25 Feb 2020.