Repetitive Applications of Pruritogens and Effects of a Cutaneous-induced Pain Stimulation on Nonhistaminergic Itch Perception
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Assessment of itch intensity using a VAS scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
Participant will be blinded about application of pruritogens.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women
- •18-60 years
- •Speak and understand English
排除标准
- •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)
结局指标
主要结局
Assessment of itch intensity using a VAS scale
时间窗: 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'.
Retrospective rating of the pain perceived on a NRS
时间窗: 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)
Assessment of pain intensity using a VAS scale
时间窗: 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'.
次要结局
- Alloknesis(12 minutes post itch provocation)
- Mechanically evoked itch(15 minutes post itch provocation)
研究者
Silvia Lo Vecchio
Assistant Professor
Aalborg University