The Effect of Palmitylethanolamide on Central and Peripheral Sensitization After Heat-induced Hyperalgesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Change in conditioned pain modulation
研究概览
简要总结
This planned study is based on a randomized, placebo-controlled cross-over design.
Palmityhlethanolamide (PEA) is an endogenous fatty acid amide from the group of N-Acetylethanolamides, which analgesic, anti-inflammatory and neuroprotective effects can be attributed to this. In clinical studies, PEA has mainly been used as an adjuvant in pain therapy. The previous data show clinical efficacy without conclusions that can be drawn about the underlying mechanisms - these have not yet been investigated in a human experiment.
The planned study, which demonstrates the mode of action of PEA using an established pain model on healthy volunteers, will help to assign the efficacy to peripheral or central nervous systems. These mechanisms allow to establish mechanism-oriented therapy approaches. These findings are essential for a better understanding of the clinical efficacy and to evaluate the correct fields of application.
详细描述
Palmityhlethanolamide (PEA) is an endogenous fatty acid amide from the group of N-Acetylethanolamides, which analgesic, anti-inflammatory and neuroprotective effects can be attributed to this. It is referred to as "dietary Food for special medical purposes". Different mechanisms of action have been described, including an effect on mast cells, ATP-sensitive K channels and TRP channels. In an animal study in mice it could be shown that the antinociceptive properties of PEA can be blocked by a CB2-cannabinoid antagonist. Overall, PEA seems to play a relevant role in the body's own regulation of neurogenic inflammation.
In clinical studies, PEA has mainly been used as an adjuvant in pain therapy. In a recent metaanalysis of studies in which PEA was used to treatment of neuropathic or chronic pain, a significant effect can be shown. Remarkably none of the 1188 patients who took PEA for up to 60 days had reported side effects.
"Repetitive phasic heat application" is a validated method to generate a short-term peripheral and central sensitization. As a non-invasive human pain model, it is therefore well suited to examine analgesic and antihyperalgesic effects of pharmaceuticals.
The data of the above meta-analysis show clinical efficacy without conclusions that can be drawn about the underlying mechanisms - these have not yet been investigated in a human experiment. Our planned study, which demonstrates the mode of action of PEA using an established pain model on healthy volunteers, will help to assign the efficacy to peripheral or central nervous systems. These mechanisms allow to establish mechanism-oriented therapy approaches. These findings are essential for a better understanding of the clinical efficacy and to evaluate the correct fields of applikation. If there is peripheral efficacy, this would qualify PEA for use in acute pain. However, if the effect is explained by central mechanisms, PEA can be useful in the area of chronic pain, and also in neuropathic pain. Accordingly, the results of this experimental human study are groundbreaking for the planning of future application studies or clinical use.
Questions:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The masking is done by the pharmacological department also produces the placebos
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Exclusion Criteria:
- •Chronic pain
- •Analgesic intake
- •Neurological illness
- •Dermatological illness
- •Cardiovascular illness
- •PEA Allergy
排除标准
- •Chronic pain
- •Analgesic intake
- •Neurological illness
- •Dermatological illness
- •Cardiovascular illness
- •PEA Allergy
结局指标
主要结局
Change in conditioned pain modulation
时间窗: -->Day 0 -->Day 28 before repeated heat application -->Day 28 1 hour after repeated heat application --> Day 56 -->Day 112 before repeated heat application -->Day 112 1 hour after repeated heat application
measures the descending analgesic System with the help of a pressure agometer in kg
Change in spontaneous pain intensity
时间窗: -->Day 0 -->Day 28 before repeated heat application -->Day 28 1 hour after repeated heat application --> Day 56 -->Day 112 before repeated heat application -->Day 112 1 hour after repeated heat application
is measured on a visual analogue scale (0 means no pain and 10 means the worst imaginable pain)
Change in Allodynia
时间窗: -->Day 0 -->Day 28 before repeated heat application -->Day 28 1 hour after repeated heat application --> Day 56 -->Day 112 before repeated heat application -->Day 112 1 hour after repeated heat application
measured in radial distance in mm
Change in heat detection threshold
时间窗: -->Day 0 -->Day 28 before repeated heat application -->Day 28 1 hour after repeated heat application --> Day 56 -->Day 112 before repeated heat application -->Day 112 1 hour after repeated heat application
measured in degrees
Change in Hyperalgesia
时间窗: -->Day 0 -->Day 28 before repeated heat application -->Day 28 1 hour after repeated heat application --> Day 56 -->Day 112 before repeated heat application -->Day 112 1 hour after repeated heat application
measured with pinpricks, that are preset different peak stimulus. A numerical scale (0-100) is used to measure how painful the stimulus is.
Change in heat pain threshold
时间窗: -->Day 0 -->Day 28 before repeated heat application -->Day 28 1 hour after repeated heat application --> Day 56 -->Day 112 before repeated heat application -->Day 112 1 hour after repeated heat application
measured in degrees
次要结局
未报告次要终点