Central Sensitization in Familial Mediterranean Fever (FMF)

checkorphan
Learn more about:
Familial Mediterranean fever
Related Clinical Trial
Study of Colchicine Resistance in Familial Mediterranean Fever Safety and Efficacy of RPH-104 Used to Prevent Recurrent Fever Attacks in Adult Patients With Colchicine Resistant or Colchicine Intolerant Familial Mediterranean Fever Central Sensitization in Familial Mediterranean Fever (FMF) Efficacy and Safety of RPH-104 for Resolution and Prevention of Recurring Attacks in Adult Subjects With Familial Mediterranean Fever With Resistance to or Intolerance of Colchicine Effects of Online Aerobic Exercise Training and Physical Activity Counseling in Juvenile Familial Mediterranean Fever Characterization of a Functional Test for Mediterranean Family Fever Screening – 2 Study of the Safety and Efficacy of NC-503 in Secondary (AA) Amyloidosis Heat Intolerance in the Group of FMF Patients Magnetic Resonance (MR) Spectroscopy In Familial Mediterranean Fever (FMF) Patients Pharmacokinetics Study of Colchicine in Familial Mediterranean Fever (FMF) Patients The Comparison of the Efficacy of Once and Twice Daily Colchicine Dosage in Pediatric Patients With FMF Inflammatory Proteins in Familial Mediterranean Fever During Attack and Remission Tocilizumab for the Treatment of Familial Mediterranean Fever Controlled Ceasing of Colchicine Therapy in Familial Mediterranean Fever (FMF) Patients With Single MEFV (Mediterranean Fever) Gene Mutation The Effect of Probiotics on Response to Therapy and on Adverse Effect in Patients Treated With Colchicine for Familial Mediterranean Fever. A Diagnostic Test for Familial Mediterranean Fever Efficacy and Safety of Canakinumab in Patients With Colchicine Resistant Familial Mediterranean Fever Rilonacept for Treatment of Familial Mediterranean Fever (FMF)

Brief Title

Central Sensitization in Familial Mediterranean Fever (FMF)

Official Title

Central Sensitization in Familial Mediterranean Fever: A Cross-Sectional Observational Study

Brief Summary

      Familial Mediterranean Fever (FMF) is an autosomal recessive inherited disease with a course
      of autoinflammation, which is characterized by the episodes of fever and serositis. Central
      sensitization (CS) is defined as increased response to normal or sub-threshold stimuli of
      central nervous system and its close relationship with many rheumatological diseases has been
      demonstrated in several studies. However, there are no data on the frequency of CS in FMF
      patients.

Detailed Description

      Familial Mediterranean fever (FMF) is a self-limiting autoinflammatory disease with
      well-defined genetic and clinical features. Recurrent episodes of fever and serositis
      accompanied by increased acute phase reactants and good response to colchicine are the core
      components of the disease. The frequency of this disease, which is common in Eastern
      Mediterranean countries, is variable according to regions, but it is reported as 1/1000. In
      the pathogenesis of the disease, the mutation of the MEFV (Mediterranean Fever) gene, which
      is located on the 16th chromosome and encodes the pyrin protein, is known as the basic
      mechanism.In rheumatic diseases, inflammatory mediators cause CS by first creating changes in
      the regulation of pain in peripheral neurons and then in spinal and supraspinal pathways.
      Stimulation of peripheral nerves by mediators released during inflammation results in
      neurogenic inflammation, which is among the peripheral sensitization (PS) mechanisms. PS is
      defined as the increased sensitivity of nociceptive neurons to normal or below-threshold
      stimuli and constitutes the first step in the development of CS.Similar to other autoimmune
      diseases, it is possible that the neuroinflammatory process triggers peripheral and central
      sensitization mechanisms in FMF patients and affects pain pathways.

Study Type

Observational

Primary Outcome

Central Sensitization Inventory (CSI)

Secondary Outcome

 Short form-36 (SF-36)

Condition

Familial Mediterranean Fever

Intervention

Central Sensitization Inventory

Study Arms / Comparison Groups

 FMF patients
Description:  Patients with diagnosed FMF

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Diagnostic Test

Estimated Enrollment

80

Start Date

June 1, 2021

Completion Date

March 3, 2022

Primary Completion Date

December 31, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Agree to participate in the study

        Exclusion Criteria:

          -  Had another systemic inflammatory rheumatic diseases

          -  Using centrally acting pain medications (e.g., pregabalin, duloxetine, opioids) or
             glucocorticoids (>10 mg prednisone or its equivalent)

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Canan Sanal- Toprak, Asst.Prof, 05385577059, [email protected]

Location Countries

Turkey

Location Countries

Turkey

Administrative Informations

NCT ID

NCT05177120

Organization ID

06.12.2019.1053

Responsible Party

Sponsor

Study Sponsor

Marmara University

Study Sponsor

Canan Sanal- Toprak, Asst.Prof, Study Chair, Marmara University

Verification Date

December 2021