Immunolabeling Evaluation of Five Selected Markers in Skin Biopsies of Patients With Postherpetic Neuralgia (PHN) and Age and Gender-Matched Normal Controls
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- use of genetic data to enhance the search for targeted therapeutic approaches to chronic pain management
研究概览
简要总结
Postherpetic Neuralgia is a painful nerve condition that can occur when nerve fibers are damaged following an outbreak of shingles.
The purpose of this study is to identify and study abnormalities in the nerves and cells in the of patients with postherpetic Neuralgia (PHN) and characterize changes that could be responsible for causing nerve pain. This data will be compared to the tissue of healthy volunteers. Our goal is that this information will lead to the development of better treatment options for people with painful nerve conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 95 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Group 1: 5 Caucasian males >50 years of age with PHN of greater than 6 months duration since rash healed and clinically meaningful pain (Visual Analog Scale (VAS) >40mm at Baseline) Group 2: 5 Caucasian males >50 years of age, non-diabetic with no nervous system disease (healthy control groups)
排除标准
- •History of clinically significant liver disease, serious peripheral vascular disease, a blood clotting disorder, or any other medical condition felt to be exclusionary by the investigator
- •Allergy to lidocaine
- •Unwillingness to sign informed consent or any other reasons for which the investigator feels the subject cannot complete the study
- •History of slow-healing diabetic foot ulcers
- •HgA1c >11% within the last three months
- •Active cancer within the previous two years, except treated basal cell carcinoma of the skin
- •Co-morbidities that can produce neuropathy
- •Subjects taking sodium channel blockers within one week of study treatment and throughout the study
- •Subjects taking any other experimental drugs within 30 days prior to enrollment
- •Application of lidocaine patch to either foot or to PHN site within two weeks of enrollment
结局指标
主要结局
use of genetic data to enhance the search for targeted therapeutic approaches to chronic pain management
时间窗: One year
The skin biopsies will be used to identify the site of expression of selected makers in skin, including nerve fibers and skin substructures in patients with PHN and age and gender-atched normal controls.
次要结局
未报告次要终点
研究者
Charles Argoff
Principal Investigator
Albany Medical College