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临床试验/NCT02808611
NCT02808611已完成不适用

Konditionerende Smertestimuli - Sammenligning af Forskellige Test og Konditioneringsmodaliteter

Kristian Kjær Petersen1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2016年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
1
主要终点
CPM efficacy

研究概览

简要总结

An extensive amount of studies indicate that conditioned pain modulation (CPM) test paradigms can be of use to evaluate the efficacy of the endogenous pain inhibition pathway in healthy controls and pain patients. A number of studies indicate that the autonomic nervous system (ANS) responds to painful stimulation by parasympathetic activity withdrawal and up-regulation of sympathetic activity (flight-or-fight mode), but it remains unknown whether these responses predict individual pain susceptibility or CPM efficacy and whether different pain modalities evoke different physiological stress responses, i.e. do individuals with low pain tolerance exhibit more vigorous ANS responses when subjected to controlled acute pain stimuli, and do high ANS responsiveness to pain coincide with altered psychophysical pain levels/CPM efficacy.

This study aims to investigate the effect of ANS responsiveness on CPM paradigms and to investigate if an exogenous, pharmaceutically induced decrease in the sympathetic drive of the ANS will yield decreased CPM efficacy.

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)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Healthy subjects

排除标准

  • Drug addiction defined as the use of cannabis, opioids or other drugs
  • Previous history of neurologic, musculoskeletal, mental illnesses or a chronic pain condition
  • Lack of ability to cooperate
  • Current use of medications that may affect the trial, e.g., analgesics, anti-inflammatory drugs
  • Consumption of alcohol, caffeine, nicotine or painkillers the morning and until termination of the study on the study day
  • Recent history of acute pain affecting the lower limb
  • Participation in other pain trials throughout the study period
  • Known diagnosis of cardio vascular diseases (low blood pressure, heart conditions)
  • Decreased function of liver and kidneys

研究组 & 干预措施

Propranolol

Active Comparator

Propranolol is a beta-blocker

干预措施: propranolol (Drug)

Placebo

Placebo Comparator

Placebo

干预措施: Placebo (Drug)

结局指标

主要结局

CPM efficacy

时间窗: 1-2 hours after propranolol/placebo and after 10 minutes break.

A test stimuli will be applied and compared with a test stimuli simultaneous a condition stimuli.

次要结局

  • Temporal summation of pain(1-2 hours after propranolol/placebo and after 10 minutes break.)
  • Heart-rate variability(1-2 hours after propranolol/placebo and after 10 minutes break.)
  • Offset analgesia(1-2 hours after propranolol/placebo and after 10 minutes break.)

研究者

发起方
Kristian Kjær Petersen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kristian Kjær Petersen

M.Sc, Ph.d.

Aalborg University

研究点 (1)

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