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临床试验/NCT05177120
NCT05177120已完成不适用

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

Marmara University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Central Sensitization Inventory (CSI)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Agree to participate in the study

排除标准

  • Had another systemic inflammatory rheumatic diseases
  • Using centrally acting pain medications (e.g., pregabalin, duloxetine, opioids) or glucocorticoids (>10 mg prednisone or its equivalent)

结局指标

主要结局

Central Sensitization Inventory (CSI)

时间窗: 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.

次要结局

  • Pittsburgh Sleep Quality Index (PSQI)(6 months)
  • Familial Mediterranean Fever Quality of Life Scale (FMF-QoL)(6 months)
  • Fibromyalgia Rapid Screening Tool (FIRST).(6 months)
  • Short form-36 (SF-36)(6 months)
  • Health Assessment Questionnaire (HAQ)(6 months)
  • Hospital Anxiety and Depression Scale (HADS)(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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