Frequency of Fibromyalgia in Behcet Disease

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.

Study Overview

• Status: Completed
• Conditions: Behcet Syndrome; Fibromyalgia
• Intervention / Treatment: Diagnostic test: group 1:Patients diagnosed with Behcet disease; Diagnostic test: group 2: Patient diagnosed with fibromyalgia without Behcet disease

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 Type: Observational
• Enrollment (Actual): 146

Contacts and Locations

Study Locations

• Turkey
  • Bursa, Turkey, 16230
    • Bursa Yüksek İhtisas Education and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; group Behcet	Diagnostic test: group 1:Patients diagnosed with Behcet disease; Frequency and severity of fibromyalgia will be investigated in patient diagnosed with Behcet disease
2; group fibromyalgia	Diagnostic test: group 2: Patient diagnosed with fibromyalgia without Behcet disease; Severity of fibromyalgia will be investigated in patient diagnosed with fibromyalgia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Bursa Yüksek İhtisas Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2018
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): February 28, 2019

Study Registration Dates

• First Submitted: April 20, 2018
• First Submitted That Met QC Criteria: April 20, 2018
• First Posted (Actual): May 2, 2018

Study Record Updates

• Last Update Posted (Actual): February 25, 2020
• Last Update Submitted That Met QC Criteria: February 23, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Fibromyalgia; Trigger points; Behcet Disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Skin Diseases; Eye Diseases; Genetic Diseases, Inborn; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Stomatognathic Diseases; Mouth Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Vasculitis; Hereditary Autoinflammatory Diseases; Skin Diseases, Genetic; Skin Diseases, Vascular; Behcet Syndrome; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 2011-KAEK-25 2018/03-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No