NCT05427877Unknown不适用
Safety of Pulsing Heating Device Use on the Skin
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Pain - Visual Analog Scale
研究概览
简要总结
We hope to assess the safety of a recurrent heating device for pain relief.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals in good general health.
- •No known medical conditions that, in the investigator's opinion, may interfere with study participation.
- •Subjects 18 year of age and older.
排除标准
- •Individuals who have history of acute or chronic disease that would likely interfere with or increase the risk on study participation at the discretion of the investigator.
- •Individuals with peripheral neuropathy or a neuropathic condition that would alter their ability to sense pain.
- •Individuals with clinically significant unstable medical disorders that would disqualify the participant at the discretion of the investigator.
- •Individuals who have history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study at the discretion of the investigator.
- •Women who are pregnant.
结局指标
主要结局
Pain - Visual Analog Scale
时间窗: 100 minutes
Subjective reporting of pain with 10 point pain scale 0= no pain 10= very severe pain
Erythema (skin redness)
时间窗: 100 minutes
Measured with skin colorimeter
Post-inflammatory hyperpigmentation
时间窗: 100 minutes
Measured with skin colorimeter
次要结局
- Pain - Visual Analog Scale(1 week)
- Mood and Anxiety Assessment(1 week)
- Erythema (skin redness)(1 week)
- Post-inflammatory hyperpigmentation(1 week)
研究者
Jessica Maloh, ND
Prinicipal Investigator
Integrative Skin Science and Research
研究点 (2)
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