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NCT Number: NCT03543709

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

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.

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Key information

Conditions

Behcet's Disease Behcet Syndrome Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Fibromyalgia Genetic Diseases, Inborn Hereditary Autoinflammatory Diseases Mouth Diseases Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Panuveitis Rheumatic Diseases Skin Diseases Skin Diseases, Genetic Skin Diseases, Vascular Skin and Connective Tissue Diseases Stomatognathic Diseases Uveal Diseases Uveitis Uveitis, Anterior Vascular Diseases Vasculitis

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Koray

Bursa, 16230, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fibromyalgia 2013 criteria

Diagnostic Test

Frequency of fibromyalgia will be investigated in women diagnosed with Behcet disease

Behcet's disease current activity form

Other

Disease activity will be investigated in women with Behçet's disease without fibromyalgia.

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 1, 2018
Registry last updated
Feb 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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