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

Overview

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.

Full Title of Study: “Evaluation of Fibromyalgia With Disease Activity and Clinical Findings in Women With Behçet’s Disease in Province Bursa”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 5, 2019

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Behcet and fibromyalgia
    • Women with Behcet’s disease with fibromyalgia
  • Behcet
    • Women with Behcet’s disease without fibromyalgia

Clinical Trial Outcome Measures

Primary Measures

  • Fibromyalgia 2013 criteria
    • Time Frame: 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 Measures

  • Behcet’s disease current activity form
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bursa Yüksek İhtisas Education and Research Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Koray Ayar, Assistant Professor – Bursa Yüksek İhtisas Education and Research Hospital

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