Differences in Sensitization Between Men and Women After Cutaneous Thermal Stimuli
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Change in spatial extent of mechanical hypersensitivity after intervention w.r.t. baseline
研究概览
简要总结
Many chronic pain conditions show clear differences between between men and women, such as reported pain intensities or treatment effects, with chronic pain conditions being generally more frequent in women. Yet, the underlying mechanisms causing these differences are poorly understood. Central sensitization (CS) is considered one important mechanism in pain patients which differs between female and male patients. The central hypothesis is that already in the healthy population CS processes are more pronounced in women than in men.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •good general health
- •able to give informed consent
排除标准
- •pain complaints for more than two consecutive days over the past three months
- •any major medical or psychiatric condition (e.g. heart disease, major depressive disorder)
- •any chronic pain condition
- •inability to follow study instructions
- •consumption of stimulants, drugs, or analgesics within the past 24 hours
- •scar tissue or generally reduced sensitivity in the designated testing site areas
结局指标
主要结局
Change in spatial extent of mechanical hypersensitivity after intervention w.r.t. baseline
时间窗: 10-20 minutes before intervention (baseline) and 20-30 minutes after intervention
Mapping of hypersensitivity in cm2 of sensitized skin area using two quantitative sensory testing tools (256mN von Frey filament and 200-400mN brush) before and after intervention
Changes to the nociceptive withdrawal reflex (NWR) after intervention w.r.t. baseline
时间窗: 5-10 minutes before intervention (baseline) and 30-35 minutes after intervention
Repetitive suprathreshold elicitation of the NWR to monitor its characteristics (such as magnitude and number of responses) before and after intervention
次要结局
未报告次要终点
研究者
Schweinhardt Petra
Head of Research at the Department of Chiropractic Medicine
Balgrist University Hospital