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Completed

NCT Number: NCT05177120

Central Sensitization in Familial Mediterranean Fever (FMF)

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.

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Key information

Conditions

Familial Mediterranean Fever Central Sensitisation Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hereditary Autoinflammatory Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Feyza Nur Yücel

Sinop, 57200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Central Sensitization Inventory

Diagnostic Test

Standardized questionnaire to determine the level of central sensitization

Other names: CSI

Short Form-36

Other

Standardized questionnaire to investigate the quality of life in patients

Other names: SF-36

Pittsburgh Sleep Quality Index

Other

Standardized questionnaire to investigate the sleep quality and disturbance

Other names: PSQI

Health assessment questionnaire

Other

Standardized questionnaire used to detect the presence of disability

Other names: HAQ

Hospital Anxiety and Depression Scale

Other

Standardized questionnaire to investigate the depression and anxiety

Other names: HADS

Fibromyalgia rapid screening tool

Diagnostic Test

Standardized questionnaire to determine the presence of fibromyalgia

Other names: FIRST

Familial Mediterranean Fever Quality of life scale

Other

Standardized questionnaire to investigate the quality of life in Familial Mediterranean Fever patients

Other names: FMFQoL

Primary outcomes

  1. Central Sensitization Inventory (CSI)

    Time frame: 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 outcomes

  1. Short form-36 (SF-36)

    Time frame: 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.

  2. Familial Mediterranean Fever Quality of Life Scale (FMF-QoL)

    Time frame: 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.

  3. Health Assessment Questionnaire (HAQ)

    Time frame: 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.

  4. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 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.

  5. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 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.

  6. Fibromyalgia Rapid Screening Tool (FIRST).

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

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

Acronym: FMF

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 4, 2022
Registry last updated
Nov 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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