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

Sponsor
Bursa Yüksek İhtisas Education and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03543709
Collaborator
(none)
72
1
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Study Details

Study Description

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 Phase
  • 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.

Study Design

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

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Fibromyalgia 2013 criteria [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Koray Bursa Turkey 16230

Sponsors and Collaborators

  • Bursa Yüksek İhtisas Education and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Koray Ayar, Assistant Professor, Bursa Yüksek İhtisas Education and Research Hospital
ClinicalTrials.gov Identifier:
NCT03543709
Other Study ID Numbers:
  • 2011-KAEK-26/105
First Posted:
Jun 1, 2018
Last Update Posted:
Feb 6, 2019
Last Verified:
Feb 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Koray Ayar, Assistant Professor, Bursa Yüksek İhtisas Education and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 6, 2019