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临床试验/NCT01345877
NCT01345877已完成不适用

Pain Sensitivity in Acute Inflammatory Pain - Gender Differences and Validity of Sensory Tests

University of Copenhagen2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
pain following burn injury

研究概览

简要总结

Pain is a complex experience influenced by gender and genetics, and, by psychosocial and sensory experiences. Pain sensitivity is thus highly variable between individuals.

In the present study we evaluate individuals´ pain perception in response to a number of different pain stimuli in 100 healthy volunteers (50 females and 50 males).

The data will allow us to assess pain sensitivity, to predict pain responses and to investigate gender related differences in pain perception.

A second aim is to evaluate the robustness of the different pain-tests since the tests are repeated with an interval of 2-4 weeks.

详细描述

Pain perception is affected by physiological, psychological, existential and demographic factors.

In the present study psychophysiological, psychological, genetic and demographic components in pain perception are evaluated in healthy volunteers (n = 100).

Psychophysical assessments following induction of a first degree burn injury (47.0 C, 420 s, 12.5 sq.cm, lower leg) include:

  • pain during induction of burn injury
  • thermal thresholds
  • tactile thresholds
  • electrical thresholds
  • areas of secondary hyperalgesia
  • pressure algometric assessments
  • assessment of Diffuse Noxious Inhibitory Control (DNIC) efficiency
  • assessment of (DNIC) using cold pressor test

Psychological assessments include:

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
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • psychomotor ability to perform the tests
  • cognitive ability to perform the tests

排除标准

  • Body Mass Index > 28
  • participation in drug studies < 4 weeks prior to inclusion
  • chronic pain
  • chronic intake of analgesics
  • drug or alcohol abuse
  • intake of analgesics < 48 hours prior to study
  • females not on contraceptive therapy (intra-uterine device or p-pill)
  • lesion in the assessment area

结局指标

主要结局

pain following burn injury

时间窗: from baseline to 420 s after burn injury

次要结局

  • pressure algometry assessments(95 min prior to burn injury)
  • thermal thresholds(followed for 180 min after burn injury)
  • DNIC-efficiency(45 min before burn injury)
  • A118G SNP(8 months after inclusion completed)
  • tactile thresholds(followed for 180 min after burn injury)
  • cold pressor test(85 min before burn injury)
  • HADS score(2 hours before the burn injury)
  • PCS ratings(2 hours before the burn injury)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

mads u werner

MD, DMSci

University of Copenhagen

研究点 (2)

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