Central Sensitization in Familial Mediterranean Fever (FMF)

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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

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


Primary Outcome

Central Sensitization Inventory (CSI)

Secondary Outcome

 Short form-36 (SF-36)


Familial Mediterranean Fever


Central Sensitization Inventory

Study Arms / Comparison Groups

 FMF patients
Description:  Patients with diagnosed FMF


* 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


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)




18 Years - 75 Years

Accepts Healthy Volunteers



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

Location Countries


Location Countries


Administrative Informations



Organization ID


Responsible Party


Study Sponsor

Marmara University

Study Sponsor

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

Verification Date

December 2021