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NCT Number: NCT03514056

Frequency of Fibromyalgia in Behcet Disease

In various studies, the incidence of fibromyalgia in Behçet's patients is widely distributed. It was aimed to investigate the frequency and severity of fibromyalgia in Behcet disease in province Bursa.

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Key information

Conditions

Fibromyalgia Behcet Syndrome Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases 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

All sexes

Study type

Observational

Primary location

Bursa Yüksek İhtisas Education and Research Hospital

Bursa, 16230, Turkey (Türkiye)

About this study

There are few studies in the literature investigating the frequency of fibromyalgia in Behçet's disease. In various studies, the incidence of fibromyalgia in Behçet's disease was 5.7% -37.1%, which is widely distributed. There are no studies in literature comparing disease severity and pain thresholds at trigger points in fibromyalgia with and without Behcet's disease. In this study, it was aimed to investigate the frequency of fibromyalgia in Behcet's disease according to the criteria defined by the American Colloge of Rheuatology in 2010 and updated in 2013. It was also aimed to compare the severity of disease in fibromyalgia with and without Behcet's disease.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients diagnosed with Behcet disease according to international study group criteria
  • Patients diagnosed with fibromyalgia according to classification criteria that were defined by the American Collage of Rheumatology in 2010 and updated in 2013
  • 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

group 1:Patients diagnosed with Behcet disease

Diagnostic Test

Frequency and severity of fibromyalgia will be investigated in patient diagnosed with Behcet disease

group 2: Patient diagnosed with fibromyalgia without Behcet disease

Diagnostic Test

Severity of fibromyalgia will be investigated in patient diagnosed with fibromyalgia

Primary outcomes

  1. fibromyalgia 2013 criteria

    Time frame: Six 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. Fibromyalgia impact questionnaire

    Time frame: Six days

    The fibromyalgia impact questionnaire (FIQ) has 21 individual questions . All questions are based on an 11-point numeric rating scale of 0 to 10, with 10 being 'worst'. In the FIQ, all questions are framed in the context of the past 7 days. The total maximal score of the FIQ is 100.

  2. Pain thresholds

    Time frame: Six months

    Pain thresholds will be recorded by applying pressure to the 28 sensitive points until the participants demonstrate pain. Manual algometry device will be used to measure the pain threshold.

Sponsors and collaborators

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Other Gov

Registry information

Official study title

Frequency of Fibromyalgia in Behcet Disease in Province Bursa

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 2, 2018
Registry last updated
Feb 25, 2020

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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