Central Sensitization in Familial Mediterranean Fever (FMF)

Completed

• Conditions: Familial Mediterranean Fever; Central Sensitisation
• Interventions: Diagnostic Test: Central Sensitization Inventory; Other: Short form-36; Other: Pittsburgh Sleep Quality Index; Other: Health assessment questionnaire; Other: Hospital anxiety and depression scale; Diagnostic Test: Fibromyalgia rapid screening tool; Other: Familial Mediterranean Fever Quality of life scale

• Registration Number: NCT05177120
• Lead Sponsor: Marmara University

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 Timeline

• Study Start: 2021-06-01
• Status Verified: 2021-12
• Study First Submitted: 2022-01-03
• Study First Submitted QC: 2022-01-03
• Study First Posted: 2022-01-04
• Primary Completion: 2022-04-10
• Study Completion: 2022-08-03
• Last Update Submitted: 2022-11-09
• Last Update Posted: 2022-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
FMF patients	Pittsburgh Sleep Quality Index	Patients with diagnosed FMF
FMF patients	Hospital anxiety and depression scale	Patients with diagnosed FMF
FMF patients	Fibromyalgia rapid screening tool	Patients with diagnosed FMF
FMF patients	Familial Mediterranean Fever Quality of life scale	Patients with diagnosed FMF
FMF patients	Central Sensitization Inventory	Patients with diagnosed FMF
FMF patients	Short form-36	Patients with diagnosed FMF
FMF patients	Health assessment questionnaire	Patients with diagnosed FMF

Primary Outcome Measures

Name	Time	Method
Central Sensitization Inventory (CSI)	6 months	25 somatic and psychosocial symptoms, which are frequently found in patients with central sensitization in part A, are questioned. In part B, the presence of diseases whose relationship with central sensitization is well defined is questioned in the patient without participating in scoring. Central sensitization is assumed in patients who score 40 or more over 100 points.

Secondary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index (PSQI)	6 months	The questionnaire includes 21 questions covering 7 components that investigate the symptoms of sleep disturbances. Scores range from 0 to 21 and a score of \>5 is considered as a sleep disorder.
Familial Mediterranean Fever Quality of Life Scale (FMF-QoL)	6 months	FMF-QoL was developed to evaluate the quality of life in FMF patients. This scale consists of 20 questions in the form of a Likert scale and the total scoring is between 0-80. High scores indicate a decrease in quality of life.
Fibromyalgia Rapid Screening Tool (FIRST).	6 months	This scale consists of 6 questions investigating the most relevant clinical features of fibromyalgia. The questions are answered as yes/no and 5 or more out of 6 points in total are in favor of fibromyalgia.
Short form-36 (SF-36)	6 months	The 36-Item Short Form Survey (SF-36) is an oft-used, well-researched, self-reported measure of health.The scale consists of 36 questions questioning 8 sub-parameters regarding the health status of the person.These parameters are physical function, pain, limitation due to physical and emotional problems, emotional well-being, social function, fatigue and general health perception. High scores are associated with improved quality of life.
Health Assessment Questionnaire (HAQ)	6 months	n the scale, difficulty in performing 20 specific tasks from 8 categories is questioned and the scoring is between 0-60. High scores are associated with increased disability.
Hospital Anxiety and Depression Scale (HADS)	6 months	This scale consists of 14 questions in total, and anxiety symptoms are questioned in half of the questions and depression-related complaints in the other half. A subscore of 8 or higher for depression or anxiety is considered a clinical case.

Trial Locations

Locations (1)

Feyza Nur Yücel; 🇹🇷 Sinop, Turkey