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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03514056
Other study ID # 2011-KAEK-25 2018/03-14
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 30, 2018
Est. completion date February 28, 2019

Study information

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]

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
group 1:Patients diagnosed with Behcet disease
Frequency and severity of fibromyalgia will be investigated in patient diagnosed with Behcet disease
group 2: Patient diagnosed with fibromyalgia without Behcet disease
Severity of fibromyalgia will be investigated in patient diagnosed with fibromyalgia

Locations

Country Name City State
Turkey Bursa Yüksek Ihtisas Education and Research Hospital 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 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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