Pain and Itch Neuromodulation: Effects of Offset Analgesia, Placebo, and Nocebo and Topographical Distribution of Itch and Pain Receptors
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
- Measuring pain by computerized Visual Analog Scale Scoring
研究概览
简要总结
The experiment consists of three experimental sessions conducted on three consecutive days.
In all experimental sessions, the participant will fill in a series of questionnaires about how you perceive itch and pain, and about some traits of your personality, such as depression, anxiety and stress.
In the first session, we will mark six test areas in your face (three on each side on jaw, cheek, and temple, respectively). Thent a series of measure-ments in each test area will be conducted:measurement of the blood flow in the skin and sensitivity tests to pressure, pinprick and stroke with a brush.
In the second session, histamine will be applied in one side of the face. On the other side, cowhage spicules will be applied. After 10 minutes, all the tests will be conducted again.
The third session will be identical to the second. However, instead of histamine and spicules, patches containing capsaicin will be applied. In the other side, we will apply patches with placebo (i.e., a non-active patch). After 20 minutes all the tests will be conducted again.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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 drugs
- •Previous or current history of neurological, immunological, musculoskeletal, cardiac disorder or psychiatric diagnoses that may affect the results (e.g., neuropathy, muscular pain in the upper extremities, anxiety, depression, schizophrenia, etc.)
- •Moles, wounds, scars, or tattoos in the area to be treated or tested
- •Current use of medications that may affect the trial such as antihistamines and pain killers
- •Skin diseases
- •Consumption of alcohol or painkillers 24 hours before the study days and between these
- •Acute or chronic pain and itch
- •Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical studies)
- •Contraindications to capsaicin, including intolerance to chili or burns or wounds at the application site
- •The subject is assessed as unable to engage in the necessary cooperation required by the study
结局指标
主要结局
Measuring pain by computerized Visual Analog Scale Scoring
时间窗: Immediately after the intervention
We will ask the subjects to rate the sensation of pain on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates "no pain" and 100 indicates "worst pain imaginable".
Measuring itch by computerized Visual Analog Scale Scoring
时间窗: Immediately after the intervention
We will ask the subjects to rate the sensation of itch on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates "no itch" and 100 indicates "worst itch imaginable".
次要结局
- Warm Detection Thresholds (WDT)(Immediately after the intervention)
- Cold Pain Thresholds (CPT)(Immediately after the intervention)
- Alloknesis(Immediately after the intervention)
- Superficial blood perfusion(Immediately after the intervention)
- Mechanically evoked itch (MEI)(Immediately after the intervention)
- Mechanical Pain Sensitivity (MPS)(Immediately after the intervention)
- Cold Detection Thresholds (CDT)(Immediately after the intervention)
- Mechanical Pain Thresholds (MPT)(Immediately after the intervention)
- Heat Pain Thresholds (HPT)(Immediately after the intervention)
- Pain to Supra-threshold Heat Stimuli (STHS)(Immediately after the intervention)
- Pain Catastrophizing Scale (PCS).(10 minutes after induction)
- Itch Catastrophizing Scale (ICS).(10 minutes after induction)
- Learned Helplessness Scale (LHS)(10 minutes after every induction)
- Depression, Anxiety, Stress Scale (DASS-21)(Baseline)
- Reinforcement Sensitivity Theory - Personality Questionnaire (RST-PQ).(Baseline)
- Difficulties in Emotion Regulation Scale Short Form (DERS-SF)(Baseline)
- Emotion Regulation Questionnaire (ERQ(Baseline)
研究者
Silvia Lo Vecchio
Associate Professor
Aalborg University