Clinical trial NCT05177120: Central Sensitization in Familial Mediterranean Fever (FMF)
Official title: Central Sensitization in Familial Mediterranean Fever: A Cross-Sectional Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Familial Mediterranean Fever
Central Sensitisation
Keywords: Familial Mediterranean Fever
Central Sensitization
Central Sensitization Inventory
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with FMF

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.

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)

Primary outcomes:
measure: Central Sensitization Inventory (CSI)
timeFrame: 6 months
Secondary outcomes:
measure: Short form-36 (SF-36)
timeFrame: 6 months
measure: Familial Mediterranean Fever Quality of Life Scale (FMF-QoL)
timeFrame: 6 months
measure: Health Assessment Questionnaire (HAQ)
timeFrame: 6 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 6 months
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 6 months
measure: Fibromyalgia Rapid Screening Tool (FIRST).
timeFrame: 6 months
Other outcomes:
Locations:
city: Sinop
country: Turkey
facility: Feyza Nur Yücel
Study officials:
affiliation: Marmara University
name: Canan Sanal- Toprak, Asst.Prof
role: STUDY_CHAIR
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