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Trial record 21 of 243823 for:    Diseases

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

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ClinicalTrials.gov Identifier: NCT03543709
Recruitment Status : Completed
First Posted : June 1, 2018
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Koray Ayar, Bursa Yüksek İhtisas Education and Research Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Behcet's Disease Fibromyalgia Diagnostic Test: fibromyalgia 2013 criteria Other: Behcet's disease current activity form

Detailed Description:
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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 72 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Evaluation of Fibromyalgia With Disease Activity and Clinical Findings in Women With Behçet's Disease in Province Bursa
Actual Study Start Date : June 11, 2018
Actual Primary Completion Date : February 5, 2019
Actual Study Completion Date : February 5, 2019


Group/Cohort Intervention/treatment
Behcet and fibromyalgia
Women with Behcet's disease with fibromyalgia
Diagnostic Test: fibromyalgia 2013 criteria
Frequency of fibromyalgia will be investigated in women diagnosed with Behcet disease

Other: Behcet's disease current activity form
Disease activity will be investigated in women with Behçet's disease without fibromyalgia.

Behcet
Women with Behcet's disease without fibromyalgia
Diagnostic Test: fibromyalgia 2013 criteria
Frequency of fibromyalgia will be investigated in women diagnosed with Behcet disease

Other: Behcet's disease current activity form
Disease activity will be investigated in women with Behçet's disease without fibromyalgia.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Women diagnosed with Behcet disease according to international study group criteria, between age 18-75, which are not pregnant and which were not previously diagnosed with diabetes mellitus or chronic renal failure.
Criteria

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

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): NCT03543709


Locations
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Turkey
Koray
Bursa, Turkey, 16230
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: NCT03543709     History of Changes
Other Study ID Numbers: 2011-KAEK-26/105
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019

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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:
Behcet's disease
Fibromyalgia
Disease activity

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