跳至主要内容
临床试验/NCT05685797
NCT05685797已完成不适用

Inflammatory Cytokine and Neuropeptide Study in Patients With Herpes Zoster

Keimyung University Dongsan Medical Center2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年1月25日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
serum level of inflammatory cytokine changes during 3 time period

研究概览

简要总结

Investigators performed this study to investigate the expression levels inflammatory cytokine and neurotransmitters (calcitonin gene-related peptide (CGRP), substance P (SP), vasoactive intestinal peptide (VIP), and β-endorphin) in peripheral blood of participants with herpes zoster.

详细描述

Sudden and electrick shooting sensation of face is an important clinical feature of herpes zoster. The severe and excruciating nature of pain intensity associated with herpes zoster can impair the physical and psychosocial well-being of the patient, however, pathophysiologic mechanism of herpes zoster still remains unclear.

Recentrly, there have been a few studies suggesting biomarker levels in the blood and CSF level, however, further study is required to elucidate the action mechanism.

Up to 90% of patients can achieve pain reduction using medical therapy alone. However, 10% -15% of herpes zoster cases demonstrate a minimal response to medication with various side effects. Radiofrequency thermocoagulation (RFT) of the trigeminal ganglion is an alternative treatment option for patients who are poor candidates for microvascular decompression or show serious side effects to medication. Recent study revealed that RFT of the trigeminal ganglion resulted in Barrow Neurological Institute (BNI) pain scale I or II in 71.7% of patients, with a median time to recurrence of 36 months.

Although patients experience significant pain relief after RFT, it is uncertain whether inflammatory cytokine and neurocytokine (CGRP, substance P, VIP) are reduced.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with NRS more than 4
  • patients who failed medical treatment
  • patients showing severe adverse reaction with medication

排除标准

  • Patients showing allergic reaction to local anesthetics
  • Patients with coagulation abnormality

结局指标

主要结局

serum level of inflammatory cytokine changes during 3 time period

时间窗: Baseline, 1 week after tigeminal nerve block, 2 weeks after radiofrequency thermocoagulation

inflammatory cytokine including Tumor necrosis factor-alpha, Interleukin-6 changes during 3 time period Higher score means worse outcome

serum level of neurotransmitter changes during 3 time period

时间窗: Baseline, 1 week after tigeminal nerve block, 2 weeks after radiofrequency thermocoagulation

neurotransmitter including Calcitonene gene related peptide, substance P, vasoactive intestitinal polypeptide changes during 3 time period Higher score means worse outcome

次要结局

  • Changes of numerical rating scale changes during 3 time period(Baseline, 1 week after tigeminal nerve block, 2 weeks after radiofrequency thermocoagulation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ji Hee Hong

Professor

Keimyung University Dongsan Medical Center

研究点 (2)

Loading locations...

相似试验