Frequency of Fibromyalgia in Behcet Disease

Fibromyalgia Clinical Trial

Official title:

Frequency of Fibromyalgia in Behcet Disease in Province Bursa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03514056
• Other study ID #: 2011-KAEK-25 2018/03-14
• Status: Completed
• Start date: May 30, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: February 2020
• Source: Bursa Yüksek Ihtisas Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: February 28, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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:

• Participants which were previously diagnosed with diabetes mellitus

• Participants which were previously diagnosed with chronic renal failure

• Pregnant women

Related Conditions & MeSH terms

• Behcet Syndrome
• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Diagnostic Test:
• group 1:Patients diagnosed with Behcet disease
Frequency and severity of fibromyalgia will be investigated in patient diagnosed with Behcet disease
• group 2: Patient diagnosed with fibromyalgia without Behcet disease
Severity of fibromyalgia will be investigated in patient diagnosed with fibromyalgia

Locations

Country	Name	City	State
Turkey	Bursa Yüksek Ihtisas Education and Research Hospital	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Bursa Yüksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Six months
Secondary	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.	Six days
Secondary	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.	Six months