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临床试验/NCT05701696
NCT05701696招募中不适用

Investigation of the Relationship Between Neuropathic Complaints and Central Sensitization in Patients With Fibromyalgia

Marmara University1 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2023年1月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
111
试验地点
1
主要终点
S-LANSS

研究概览

简要总结

Fibromyalgia (FM) is the prototype of a group of diseases known as central sensitivity syndromes, whose relationship with pain sensitization is well defined. Central sensitization (CS) is also one of the mechanisms involved in the pathophysiology of neuropathic pain. Neuropathic pain, which is a common complaint in FM patients, is likely to be one of the clinical manifestations of central sensitization. Therefore, in this study, it was aimed to investigate the relationship between CS and neuropathic pain.

详细描述

The term central sensitization (CS) was first used by Wolf in 1988 and explained as an increase in pain sensitivity with the amplification of neuron-derived signals in the central nervous system. Fibromyalgia (FM) is a disease characterized by chronic widespread pain and its etiology and pathophysiology are still unknown. It is considered to be the main member of the CS related disease group known as central sensitivity syndromes with impaired pain regulation. In various studies, hyperalgesia and allodynia, which are accepted as objective findings of CS in pain sensitization. In addition to widespread body pain, neuropathic pain is one of the common symptoms in FM, and various studies have shown a significant increase in neuropathic pain in FM patients compared to healthy controls. It is known that CS is one of the basic mechanisms in the etiopathogenesis of neuropathic pain as well as its role in FM. In a study of FM patients, painDETECT and S-LANSS scores were found to be correlated with CSI scores, and the authors emphasized the relationship between pain sensitization and neuropathic complaints in these patients. CS seems likely to be one of the neuropathic pain mechanisms in FM patients, and the available data seem insufficient to draw a definitive conclusion. From this point of view, in this study, it was aimed to investigate the relationship between the presence and severity of CS and the neuropathic pain component of the disease in patients with FM.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosing fibromyalgia according to ACR 2016 criteria
  • Between the ages of 18-65
  • Agree to participate in the study

排除标准

  • History of concomitant systemic inflammatory disease, active infection and malignancy
  • Refusing to participate in the study
  • Polyneuropathy, entrapment neuropathy, and radiculopathy are other diagnosed sources of neuropathic pain.

结局指标

主要结局

S-LANSS

时间窗: 1 year

Questionnaire used to investigate the neuropathic character of pain. A score ≥12 points suggests the presence of pain of neuropathic origin

CSI

时间窗: 1 year

Standardized questionnaire to determine the level of central sensitization. Patients with a score of 40 and above are considered to have central sensitization.

次要结局

  • Symptom severity scale(1 year)
  • Fibromyalgia impact scale(1 year)
  • Visual analog scale ( VAS) pain(1 year)
  • Widespread pain index(1 year)
  • HADS(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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