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

Completed

• Conditions: Behcet's Disease; Fibromyalgia
• Interventions: Diagnostic Test: fibromyalgia 2013 criteria; Other: Behcet's disease current activity form

• Registration Number: NCT03543709
• Lead Sponsor: Bursa Yüksek İhtisas Education and Research Hospital

Brief Summary

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.

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 Timeline

• Study First Submitted: 2018-05-21
• Study First Submitted QC: 2018-05-21
• Study First Posted: 2018-06-01
• Study Start: 2018-06-11
• Status Verified: 2019-02
• Primary Completion: 2019-02-05
• Study Completion: 2019-02-05
• Last Update Submitted: 2019-02-05
• Last Update Posted: 2019-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Behcet and fibromyalgia	fibromyalgia 2013 criteria	Women with Behcet's disease with fibromyalgia
Behcet and fibromyalgia	Behcet's disease current activity form	Women with Behcet's disease with fibromyalgia
Behcet	Behcet's disease current activity form	Women with Behcet's disease without fibromyalgia
Behcet	fibromyalgia 2013 criteria	Women with Behcet's disease without fibromyalgia

Primary Outcome Measures

Name	Time	Method
Fibromyalgia 2013 criteria	5 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
Behcet's disease current activity form	5 months	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.

Trial Locations

Locations (1)

Koray; 🇹🇷 Bursa, Turkey