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Frequency of Fibromyalgia in Behcet Disease

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ClinicalTrials.gov Identifier: NCT03514056
Recruitment Status : Recruiting
First Posted : May 2, 2018
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Koray Ayar, Bursa Yüksek İhtisas Education and Research Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Fibromyalgia Behcet Syndrome Diagnostic Test: group 1:Patients diagnosed with Behcet disease Diagnostic Test: group 2: Patient diagnosed with fibromyalgia without Behcet disease

Detailed Description:
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Frequency of Fibromyalgia in Behcet Disease in Province Bursa
Actual Study Start Date : May 30, 2018
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : February 1, 2019


Group/Cohort Intervention/treatment
1
group Behcet
Diagnostic Test: group 1:Patients diagnosed with Behcet disease
Frequency and severity of fibromyalgia will be investigated in patient diagnosed with Behcet disease

2
group fibromyalgia
Diagnostic Test: group 2: Patient diagnosed with fibromyalgia without Behcet disease
Severity of fibromyalgia will be investigated in patient diagnosed with fibromyalgia




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study population consists of participants who are between age 18-75, not pregnant and who were not diagnosed previously with diabetes mellitus or chronic renal failure
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514056


Contacts
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Contact: Koray Ayar, 1 +902242955000 ext 1652 ayarkoray@hotmail.com
Contact: Burcu Okmen, 2 +902242955000 burcumetinokmen@gmail.com

Locations
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Turkey
Bursa Yüksek İhtisas Education and Research Hospital Recruiting
Bursa, Turkey, 16230
Contact: koray Ayar    +902242955000    ayarkoray@hotmail.com   
Sponsors and Collaborators
Bursa Yüksek İhtisas Education and Research Hospital

Additional Information:

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Responsible Party: Koray Ayar, Assistant Professor, Bursa Yüksek İhtisas Education and Research Hospital
ClinicalTrials.gov Identifier: NCT03514056     History of Changes
Other Study ID Numbers: 2011-KAEK-25 2018/03-14
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Koray Ayar, Bursa Yüksek İhtisas Education and Research Hospital:
Fibromyalgia
Behcet Disease
Trigger points

Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Behcet Syndrome
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Mouth Diseases
Stomatognathic Diseases
Uveitis, Anterior
Panuveitis
Uveitis
Uveal Diseases
Eye Diseases
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Hereditary Autoinflammatory Diseases
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases
Skin Diseases, Vascular