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CompletedNCT03514056Updated Feb 25, 2020

Frequency of Fibromyalgia in Behcet Disease

An observational study in Fibromyalgia and Behcet Syndrome, sponsored by Bursa Yüksek İhtisas Education and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-02-25.

Sponsored by Bursa Yüksek İhtisas Education and Research Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
146
Ages
18 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Fibromyalgia
  • Behcet Syndrome

Keywords

  • Fibromyalgia
  • Behcet Disease
  • Trigger points
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In context

Fibromyalgia

1,336 studies on the registry are indexed under Fibromyalgia; 266 are open to participants now.

This study's enrollment of 146 is above the median of 100 across 270 observational studies indexed under Fibromyalgia.

Browse Fibromyalgia studies →

Lead sponsor

Bursa Yüksek İhtisas Education and Research Hospital is the lead sponsor of 62 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Participants which were previously diagnosed with diabetes mellitus
  • Participants which were previously diagnosed with chronic renal failure
  • Pregnant women
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
146 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • 1

    group Behcet

    Diagnostic Test: group 1:Patients diagnosed with Behcet disease

  • 2

    group fibromyalgia

    Diagnostic Test: group 2: Patient diagnosed with fibromyalgia without Behcet disease

Interventions

  • Diagnostic testgroup 1:Patients diagnosed with Behcet disease

    Frequency and severity of fibromyalgia will be investigated in patient diagnosed with Behcet disease

  • Diagnostic testgroup 2: Patient diagnosed with fibromyalgia without Behcet disease

    Severity of fibromyalgia will be investigated in patient diagnosed with fibromyalgia

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Six months

Secondary outcomes

  1. 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.

    Time frame: Six days

  2. 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.

    Time frame: Six months

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Study locations

1 site
  • Bursa Yüksek İhtisas Education and Research Hospital
    Bursa, 16230, Turkey
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03514056
Lead sponsor
Bursa Yüksek İhtisas Education and Research Hospital
Responsible party
Koray Ayar (Assistant Professor, Bursa Yüksek İhtisas Education and Research Hospital) — Principal investigator
First posted
May 2, 2018
Start date
May 30, 2018
Primary completion
Feb 1, 2019
Completion
Feb 28, 2019
Last update
Feb 25, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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