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 study consists of one experimental session of approximately 1½ hours. 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. Afterwards, two areas will be selected on each forearm of the subjects. The four areas will be treated with the same vehicle cream for 20 minutes, in order to test the placebo effect. At the end of the cream application, two areas will be randomly treated with histamine while cowhage will be applied on the other two areas. During the 10 minutes of the application of the pruritogens, itch and pain will be continuously monitored using a Visual Analog Scale.
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 Visual Analog 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 Visual Analog Scale ranging from 0 to 100 where 0 indicates "no itch" and 100 indicates "worst itch imaginable".
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 Visual Analog 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 Visual Analog Scale ranging from 0 to 100 where 0 indicates "no itch" and 100 indicates "worst itch imaginable".
次要结局
- Pain Catastrophizing Scale (PCS).(Baseline)
- Itch Catastrophizing Scale (ICS).(Baseline)
- Learned Helplessness Scale (LHS)(Baseline)
- Depression, Anxiety, Stress Scale (DASS-21)(Baseline)
- Reinforcement Sensitivity Theory - Personality Questionnaire (RST-PQ).(Baseline)
- Positive And Negative Affect Schedule (PANAS)(Baseline)
- Difficulties in Emotion Regulation Scale Short Form (DERS-SF)(Baseline)
- Emotion Regulation Questionnaire (ERQ(Baseline)
- Pain Catastrophizing Scale (PCS).(Baseline)
- Itch Catastrophizing Scale (ICS).(Baseline)
- Learned Helplessness Scale (LHS)(Baseline)
- Depression, Anxiety, Stress Scale (DASS-21)(Baseline)
- Reinforcement Sensitivity Theory - Personality Questionnaire (RST-PQ).(Baseline)
- Positive And Negative Affect Schedule (PANAS)(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