瘙痒剂的重复应用和皮肤引起的疼痛刺激对非组胺能瘙痒知觉的影响
In This experiment, the investigators would like to test following hypotheses:
the pain stimulation applied at the same time of a pruriceptive stimulus will decrease the itch perception. Moreover, also the effect of the cutaneous pain stimulus location (same forearm of the pruriceptive stimulus versus the opposite forearm) on histaminergic and non-histaminergic itch will be investigated.
研究概览
详细说明
The phenomenon that pain inhibits pain is a well-known mechanism, but it is not known if pain is inhibiting itch. In this context, the aim of this project is to investigate the extent to which thermal or neurogenic short cutaneous pain can affect the itch perception. In particular, the project aims to understand any differences in itch perception when the painful stimulation is applied on the same forearm versus the opposite forearm. The hypothesis is that by applying a painful stimulus at the same time of an itchy stimulus, the itch sensitivity will decrease; probably due to an inhibitory process conducted by interneurons (Bhlbb5 interneuron) at central level.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Aalborg、丹麦、9220
- Aalborg University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Healthy men and women
- 18-60 years
- Speak and understand English
Exclusion Criteria:
- Pregnancy or lactation
- Drug addiction defined as any use of cannabis, opioids, or other addictive drugs
- Previous or current history of neurological (e.g. neuropathy), immunological (e.g. asthma, immune deficiencies, arthritis) musculoskeletal (e.g. muscular pain in the upper extremities,), cardiac disorder, or mental illnesses that may affect the results
- Lack of ability to cooperate
- Current use of medications that may affect the trial such as antihistamines, antipsychotics, and pain killers, as well as systemic or topical steroids
- Skin diseases (e.g. atopic dermatitis, pruritus nodularis, eczema, psoriasis)
- Moles, scars, or tattoos in the area to be treated or tested.
- Consumption of alcohol or painkillers 24 hours before the study days and between these
- Acute or chronic pain
- Participation in other trials within one week of study entry (four weeks in the case of pharmaceutical trials)
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：非随机化
- 介入模型：单组作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Pain
A thermode stimulator of 3x3 cm will be placed on the areas and kept in place by means of Velcro tape. The temperature raises 1°C per second from a starting temperature of 32°C until itch reach or 46.5 °C. This temperature will be maintained for 2 minutes. Then the temperature will return to baseline temperature at a rate of 5°C /s. |
25 spicules will be inserted in the center of the predefined skin area on the mandibular area. The spicules will be gently rubbed for 15-20 seconds in circular motion to facilitate epidermal penetration. |
|
实验性的：Capsaicin
Capsaicin patches (dosage form: transdermal patch 8% Qutenza, Astellas) will be applied on one squared area (4x4 cm2). The patch will be left in place for 20 minutes after which it will be removed. |
25 spicules will be inserted in the center of the predefined skin area on the mandibular area. The spicules will be gently rubbed for 15-20 seconds in circular motion to facilitate epidermal penetration. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Assessment of itch intensity using a VAS scale
大体时间：1 minute post itch provocation
|
Immediately following the itch provocations, participants will be instructed to rate the itch intensity for 10 minutes using a digital visual analogue scale (VAS; eVAS Software: Aalborg, University, Denmark), on a tablet. The scale will be measured from 0 to 100, where 0 represents 'no itch' and 100 'worst itch imaginable'. |
1 minute post itch provocation
|
|
Assessment of pain intensity using a VAS scale
大体时间：1 minute post itch provocation
|
Immediately following the itch provocations, participants will be instructed to rate the pain intensity for 10 minutes using a digital visual analogue scale (VAS; eVAS Software: Aalborg, University, Denmark), on a tablet. The scale will be measured from 0 to 100, where 0 represents 'no pain' and 100 'worst pain imaginable'. |
1 minute post itch provocation
|
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Retrospective rating of the pain perceived on a NRS
大体时间：10 minutes post itch provocation
|
After 10 minutes of pruritogens application, a retrospective rating of the pain perceived from the thermal pain/capsaicin will be provided by the subject using a numeral rating scale (NRS) |
10 minutes post itch provocation
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Alloknesis
大体时间：12 minutes post itch provocation
|
Alloknesis sensation is measured using a standardized sensory brush (SENSELab Brush-05, Somedic AB, Hörby, Sweden) exerting a force of 200 to 400 mN. |
12 minutes post itch provocation
|
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Mechanically evoked itch
大体时间：15 minutes post itch provocation
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Mechanically evoked itch is measured using three von Frey filaments of 4.08, 4.16 and 4.31 (1.0, 1.4, 2.0 g, respectively) (North Coast Medical, Gilroy, CA). The center of the skin area is stimulated by 3 pricks, repeated 3 times in short succession. After a total of 9 stimulations, the participants will report the itch elicited on a numerical rating scale (NRS) from 0 to 10 (0 = "no itch"; 10 = "worst imaginable itch"). |
15 minutes post itch provocation
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- N-20210046 2nd project
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研究美国 FDA 监管的设备产品
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