临床试验/NCT02653703

NCT02653703已完成不适用

High-concentration L-menthol as a Counter-irritant to TRPA1-induced Neurogenic Inflammation, Thermal and Mechanical Hyperalgesia Caused by Trans-cinnamaldehyde

Aalborg University0 个研究点目标入组 14 人开始时间: 2014年10月1日最近更新: 2016年1月12日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 14
主要终点: Spontaneous pain intensity [self-reported on a visual analog scale]

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The aim of this study is to quantitatively characterize the effects of L-menthol as a topical counter-irritant on cutaneous pain and hyperalgesia provoked by topical application of the TRPA1-agonist trans-cinnamaldehyde (CA) in healthy human volunteers.

详细描述

This study is designed as an experimental model in healthy humans.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Basic Science
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 50 Years（Adult）
接受健康志愿者: 是

入选标准

•18 healthy men and women aged 18-50 years willing to abstain from alcohol, nicotine, caffeine and pain medication 24 hours before experimental sessions

排除标准

•Pregnancy
•Skin disorders (e.g. contact eczema)
•Chronic pain conditions
•Drug addiction defined as the use of cannabis, opioids or other drugs
•Previous neurologic, musculoskeletal or mental illnesses
•Lack of ability to cooperate

结局指标

主要结局

Spontaneous pain intensity [self-reported on a visual analog scale]

时间窗: 0-20 minutes with a sampling frequency of 1/1 min

Rating of the overall pain intensity on a visual analog scale (VAS ranging from "No pain" = 0, to "worst imaginable pain" =10) once every minute

次要结局

Heat hyperalgesia(25-27.5 minutes post induction)
Neurogenic inflammation [Measured by Laser speckle flowmetry in a 3x3 cm area](20-25 minutes post induction)
Mechanical hyperalgesia(27.5-30 minutes post induction)

研究者

发起方

Aalborg University

申办方类型

Other

责任方

Principal Investigator

主要研究者

Parisa Gazerani

Professor, PharmD, Ph.D.

Aalborg University

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