NCT05177120

Central Sensitization in Familial Mediterranean Fever (FMF)

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Marmara University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Familial Mediterranean Fever
• Central Sensitisation

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Central Sensitization Inventory	Standardized questionnaire to determine the level of central sensitization
OTHER	Short form-36	Standardized questionnaire to investigate the quality of life in patients
OTHER	Pittsburgh Sleep Quality Index	Standardized questionnaire to investigate the sleep quality and disturbance
OTHER	Health assessment questionnaire	Standardized questionnaire used to detect the presence of disability
OTHER	Hospital anxiety and depression scale	Standardized questionnaire to investigate the depression and anxiety
DIAGNOSTIC_TEST	Fibromyalgia rapid screening tool	Standardized questionnaire to determine the presence of fibromyalgia
OTHER	Familial Mediterranean Fever Quality of life scale	Standardized questionnaire to investigate the quality of life in Familial Mediterranean Fever patients

Timeline

• Start date: 2021-06-01
• Primary completion: 2022-04-10
• Completion: 2022-08-03
• First posted: 2022-01-04
• Last updated: 2022-11-10

Locations

1 site across 1 country: Turkey (Türkiye)