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
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Measuring pain by computerized Visual Analog Scale Scoring
研究概览
简要总结
In this study, it will be investigated if the phenomenon of offset analgesia, usually associated with painful heat stimulation, could also be induced using cold painful temperatures.
详细描述
After filling some questionnaires, two areas (4x4 cm, 4 cm apart) will be selected on each forearm of the subjects. The areas will be randomly treated with one of the following trials: hot experimental trial, hot control trial, cold experimental trial, and cold control trial.
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 (sub-project 4 only)
- •The subject is assessed as unable to engage in the necessary cooperation required by the study
研究组 & 干预措施
off-set analgesia
The tests of off-set analgesia will be performed using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device. Two protocols will be applied: heat off-set analgesia and cold off-set analgesia.
干预措施: Heat off-set analgesia (Other)
off-set analgesia
The tests of off-set analgesia will be performed using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device. Two protocols will be applied: heat off-set analgesia and cold off-set analgesia.
干预措施: Cold off-set analgesia (Other)
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
次要结局
- Pain Catastrophizing Scale (PCS).(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