Evaluation of Fibromyalgia With Disease Activity and Clinical Findings in Women With Behçet's Disease

Evaluation of Fibromyalgia With Disease Activity and Clinical Findings in Women With Behçet's Disease in Province Bursa

In the literature, the relationship between fibromyalgia and disease activity has been assessed in a few studies without discrimination between women and men.In this study, it was aimed to evaluate the relationship between fibromyalgia and disease activity in women with Behçet's disease.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia; Behcet's Disease
• Intervention / Treatment: Diagnostic test: fibromyalgia 2013 criteria; Other: Behcet's disease current activity form

Detailed Description

There are only a few studies in the literature evaluating the association of fibromyalgia with disease activity and clinical findings in Behçet's disease. In the literature, the relationship between fibromyalgia and disease activity has been assessed without discrimination between women and men. Behçet's disease is more active in men and fibromyalgia is more frequent in women. Evaluating the relationship between fibromyalgia and disease activity in Behçet's disease without gender discrimination may not be objective.There is not any study in literature evaluating relationship between fibromyalgia and disease activity in women with Behçet's disease.In this study, it was aimed to evaluate the relationship between fibromyalgia and disease activity in women with Behçet's disease.

• Study Type: Observational
• Enrollment (Actual): 72

Contacts and Locations

Study Locations

• Turkey
  • Bursa, Turkey, 16230
    • Koray

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Women diagnosed with Behcet disease according to international study group criteria, between age 18-75, which are not pregnant and which were not previously diagnosed with diabetes mellitus or chronic renal failure.

Description

Inclusion Criteria:

• Women diagnosed with Behcet disease according to international study group criteria
• 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
Behcet and fibromyalgia; Women with Behcet's disease with fibromyalgia	Diagnostic test: fibromyalgia 2013 criteria; Frequency of fibromyalgia will be investigated in women diagnosed with Behcet disease; Other: Behcet's disease current activity form; Disease activity will be investigated in women with Behçet's disease without fibromyalgia.
Behcet; Women with Behcet's disease without fibromyalgia	Diagnostic test: fibromyalgia 2013 criteria; Frequency of fibromyalgia will be investigated in women diagnosed with Behcet disease; Other: Behcet's disease current activity form; Disease activity will be investigated in women with Behçet's disease without 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	5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behcet's disease current activity form	Twelve items on the Behcet's disease current activity form, a potential unidimensional scale, will be used for the analysis as well as the two questions which assess disease activity from the patient's and clinician's perspective. These items are: a Likert scale, represented by 'smiley' faces ranging from very bad to very good, to indicate how the patient or the clinician felt the disease had been over the past 4 weeks, and the presence or absence (over the last 4 weeks prior to the clinic visit) of arthralgia, arthritis, diarrhoea, erythema nodosum, eye inflammation, genital ulcers, headaches, mouth ulcers, nausea/vomiting, new central nervous system involvement, new major vessel inflammation, and pustules.	5 months

Collaborators and Investigators

• Sponsor: Bursa Yüksek İhtisas Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2018
• Primary Completion (Actual): February 5, 2019
• Study Completion (Actual): February 5, 2019

Study Registration Dates

• First Submitted: May 21, 2018
• First Submitted That Met QC Criteria: May 21, 2018
• First Posted (Actual): June 1, 2018

Study Record Updates

• Last Update Posted (Actual): February 6, 2019
• Last Update Submitted That Met QC Criteria: February 5, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Fibromyalgia; Disease activity; Behcet's 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-26/105

Drug and device information, study documents

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