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临床试验/NCT04439994
NCT04439994已完成不适用

Activation of Plasma miRNA and Proteins as a Result of Acute Experimental Pain

Aalborg University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Protein expression over time

研究概览

简要总结

In this experiment, the investigators would like to test the following:

  1. Does acute pain induced by hypertonic injection cause changes in plasma miRNA and protein expression ?
  2. Can these canges correlate with the development of local hyperalgesia?
  3. How does the plasma miRNA expression change over a duration of 24 hours post pain induction ?
  4. Which mRNA targets are potentially affected by acute pain?

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy men and women in the age 18-80 years
  • •Speak and understand English

排除标准

  • •Acute and chronic pain
  • •Pregnancy or breastfeeding
  • •Drug addiction defined as the use of cannabis, opioids or other drugs
  • •Present or previous history of neurological, dermatological, immunological, musculoskeletal, cardiac disorder or mental illnesses that may affect the results (e.g. Neuropathy, muscular pain in the upper extremities, etc.)
  • •Lack of ability to cooperate
  • •Current use of medications that may affect the trial, such as antipsychotics and pain killers as well as systemic or topical steroids and anti-inflammatory drugs.
  • •Skin diseases
  • •Consumption of alcohol or painkillers 24 hours before the study days and between these
  • •Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)

研究组 & 干预措施

Hypertonic saline

Active Comparator

Each participant will be given i.d. in 0.1 mL volumes of a hypertonic saline solution. The subject will be blinded to the hypertonic/isotonic administration.

干预措施: hypertonic saline (Other)

Hypertonic saline

Active Comparator

Each participant will be given i.d. in 0.1 mL volumes of a hypertonic saline solution. The subject will be blinded to the hypertonic/isotonic administration.

干预措施: Blood sampling (Procedure)

Isotonic Saline

Placebo Comparator

Each participant will be given i.d. in 0.1 mL volumes of a isotonic saline solution. The subject will be blinded to the hypertonic/isotonic administration.

干预措施: Saline injection (Other)

Isotonic Saline

Placebo Comparator

Each participant will be given i.d. in 0.1 mL volumes of a isotonic saline solution. The subject will be blinded to the hypertonic/isotonic administration.

干预措施: Blood sampling (Procedure)

结局指标

主要结局

Protein expression over time

时间窗: 24 hours post-injection

Plasma protein evaluation

miRNA expression over time

时间窗: 24 hours post-injection

Plasma miRNA evaluation

miRNA expression over time

时间窗: Before injection

Plasma miRNA evaluation

miRNA expression over time

时间窗: 30 minutes post-injection

Plasma miRNA evaluation

miRNA expression over time

时间窗: 3 hours post-injection

Plasma miRNA evaluation

Protein expression over time

时间窗: Before injection

Plasma protein evaluation

Protein expression over time

时间窗: 30 minutes post-injection

Plasma protein evaluation

Protein expression over time

时间窗: 3 hours post-injection

Plasma protein evaluation

次要结局

  • Assessment of pain: visual analog scale(20 minutes)

研究者

发起方
Aalborg University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Silvia Lo Vecchio

Assistant Professor

Aalborg University

研究点 (2)

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