Characterization of Secondary Hyperalgesia in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in area of secondary hyperalgesia following brief thermal sensitization
研究概览
简要总结
In this prospective trial we aim to investigate the intra-individual and inter-individual variance in secondary hyperalgesia following pain elicited by the experimental pain model: Brief Thermal Sensitization.
Furthermore we wish to investigate how precise the psychological tests, Pain Catastrophizing Scale and Hospital Anxiety and Depression Scale predict the size of the area of secondary hyperalgesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age >18 years and <35 years
- •Speak and understand Danish
- •Male gender
- •Test subjects who have understood and signed the informed consent
- •No prescription medicine during the last 30 days
排除标准
- •* Test subjects that cannot cooperate to the test
- •* Test subjects with an alcohol and/or substance abuse, assessed by the investigator
- •* Test subjects, who have consumed one or several types of analgesics 2 \30 or \<18
研究组 & 干预措施
Experiemental pain models
all study participants will be tested with the same experimental pain models: Brief thermal sensitization, Long thermal stimulation, and Heat-pain-detection threshold.
干预措施: Brief thermal sensitization (Other)
Experiemental pain models
all study participants will be tested with the same experimental pain models: Brief thermal sensitization, Long thermal stimulation, and Heat-pain-detection threshold.
干预措施: Long thermal stimulation (Other)
Experiemental pain models
all study participants will be tested with the same experimental pain models: Brief thermal sensitization, Long thermal stimulation, and Heat-pain-detection threshold.
干预措施: Heat-pain-detection threshold (Other)
结局指标
主要结局
Change in area of secondary hyperalgesia following brief thermal sensitization
时间窗: Study day 1, 2, 3, and 4. A minimum of 4 weeks.
To determine the intra- and inter-individual variance, and the inter- and intra-observer variance of the secondary hyperalgesia areas following brief thermal sensitization on 4 separate experimental days with two different observers.
次要结局
- Score of Pain Catastrophizing Scale(7 days)
- Heat-pain-detection threshold registered by degrees celsius(1 minute per session)
- Pain following Long Thermal Stimulation, evaluated by Area under the curve of the visual analog scale.(1 minute per session)
- Score of Hospital Anxiety and Depression Scale(7 days)
- Pain following Long Thermal Stimulation, evaluated by maximum on the visual analog scale(1 minute per session)
- Score of Subscales of Pain Catastrophizing Scale and Hospital Anxiety and Depression Scale(7 days)
研究者
Morten Sejer Hansen
MD
Rigshospitalet, Denmark