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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03543709
• Other study ID #: 2011-KAEK-26/105
• Status: Completed
• Start date: June 11, 2018
• Est. completion date: February 5, 2019

Study information

• Verified date: February 2019
• Source: Bursa Yüksek Ihtisas Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 5, 2019
• Est. primary completion date: February 5, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Behcet Syndrome
• Behcet's Disease
• Fibromyalgia
• Myofascial Pain Syndromes
• Signs and Symptoms

Intervention

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.

Locations

Country	Name	City	State
Turkey	Koray	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Bursa Yüksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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