NCT03514056

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 2, 2018

Completed
28 days until next milestone

Study Start

First participant enrolled

May 30, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

8 months

First QC Date

April 20, 2018

Last Update Submit

February 23, 2020

Conditions

Keywords

FibromyalgiaBehcet DiseaseTrigger points

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Fibromyalgia impact questionnaire

    Six days

  • Pain thresholds

    Six months

Study Arms (2)

1

group Behcet

Diagnostic Test: group 1:Patients diagnosed with Behcet disease

2

group fibromyalgia

Diagnostic Test: group 2: Patient diagnosed with fibromyalgia without Behcet disease

Interventions

Frequency and severity of fibromyalgia will be investigated in patient diagnosed with Behcet disease

1

Severity of fibromyalgia will be investigated in patient diagnosed with fibromyalgia

2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • Participants which were previously diagnosed with diabetes mellitus
  • Participants which were previously diagnosed with chronic renal failure
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Yüksek İhtisas Education and Research Hospital

Bursa, 16230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

FibromyalgiaBehcet Syndrome

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesMouth DiseasesStomatognathic DiseasesUveitis, AnteriorPanuveitisUveitisUveal DiseasesEye DiseasesVasculitisVascular DiseasesCardiovascular DiseasesHereditary Autoinflammatory DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Vascular

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 20, 2018

First Posted

May 2, 2018

Study Start

May 30, 2018

Primary Completion

February 1, 2019

Study Completion

February 28, 2019

Last Updated

February 25, 2020

Record last verified: 2020-02

Locations