En Mekanistisk undersøgelse af Interaktioner Imellem Det Thermoceptive og Det Pruriceptive Sensoriske System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- eVAS Itch
研究概览
简要总结
The purpose of this human experimental study is to evaluate the pattern of itch intensity over time in response to strong, short-term heat stimulation in two different models of histamine and cowhage-induced itch. Moreover, the purpose is to evaluate the effect of mild pre-heating of the skin in human experimental models of histamine, cowhage and serotonin. Finally, we want to investigate the effect of short-term intense heat stimulation on previously anesthetized skin.
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)
盲法说明
Only the third sub-study is conducted in a double-blind manner.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women
- •Age 18-60 years
- •Able to speak and understand English
排除标准
- •Suffering from chronic disease
- •Pregnancy or lactation
- •Prior experience of adverse effects from anaesthetic, specifically Lidocaine
- •Drug addiction defined as the use of cannabis, opioids or other drugs - 5 -
- •Previous neurologic, musculoskeletal or mental illnesses
- •Lack of ability to cooperate
- •Current use of medications that may affect the trial
- •Active skin diseases
- •Active participation in other experiments currently ongoing or within the last 14 days
- •Tattoos on volar forearms that will interfere with local skin measurements
研究组 & 干预措施
lidocaine and saline+heat
干预措施: Lidocaine (Drug)
lidocaine and saline+heat
干预措施: Heat stimulation (Other)
Histamine+cowhage+heat
干预措施: Histamine (Other)
Histamine+cowhage+heat
干预措施: Cowhage (Other)
Histamine+cowhage+heat
干预措施: Heat stimulation (Other)
Histamine+cowhage+serotonin+pre-heating
干预措施: Histamine (Other)
Histamine+cowhage+serotonin+pre-heating
干预措施: Cowhage (Other)
Histamine+cowhage+serotonin+pre-heating
干预措施: Pre-heating (Other)
Histamine+cowhage+serotonin+pre-heating
干预措施: Serotonin (Other)
结局指标
主要结局
eVAS Itch
时间窗: 10 minutes
Electronic Visual Analog Scale for itch sensation. 0-100 scale, it measures the self-estimated itch the subject experience on a scale where 0 correspond to "No itch" and 100 "Worst itch imaginable".
Skin temperature
时间窗: 5 seconds
Infrared skin thermometer
eVAS Pain
时间窗: 10 minutes
Electronic Visual Analog Scale for pain sensation. 0-100 scale, it measures the self-estimated pain the subject experience on a scale where 0 correspond to "No pain" and 100 "Worst pain imaginable".
次要结局
未报告次要终点
研究者
Daniele Riccio
Principal investigator
Aalborg University