Fibromyalgia Clinical Trial
Official title:
Frequency of Fibromyalgia in Behcet Disease in Province Bursa
Verified date | February 2020 |
Source | Bursa Yüksek Ihtisas Education and Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 146 |
Est. completion date | February 28, 2019 |
Est. primary completion date | February 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Bursa Yüksek Ihtisas Education and Research Hospital | Bursa |
Lead Sponsor | Collaborator |
---|---|
Bursa Yüksek Ihtisas Education and Research Hospital |
Turkey,
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 | Six months | |
Secondary | Fibromyalgia impact questionnaire | 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. | Six days | |
Secondary | Pain thresholds | 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. | Six months |
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