Frequency of Fibromyalgia in Behcet Disease

Completed

• Conditions: Behcet Syndrome; Fibromyalgia

• Registration Number: NCT03514056
• Lead Sponsor: Bursa Yüksek İhtisas Education and Research Hospital

Brief 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.

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 Timeline

• Study First Submitted: 2018-04-20
• Study First Submitted QC: 2018-04-20
• Study First Posted: 2018-05-02
• Study Start: 2018-05-30
• Primary Completion: 2019-02-01
• Study Completion: 2019-02-28
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-23
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
fibromyalgia 2013 criteria	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

Secondary Outcome Measures

Name	Time	Method
Pain thresholds	Six months	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.
Fibromyalgia impact questionnaire	Six days	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.

Trial Locations

Locations (1)

Bursa Yüksek İhtisas Education and Research Hospital; 🇹🇷 Bursa, Turkey