Pain Response to Open Label Placebo in Induced Acute Pain in Healthy Male Adults - A Randomized Single Blinded Clinical Trail
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Pain response measured by the Area under the Pain Curve (AUPC)
研究概览
简要总结
Open Label Placebo application has been shown to be effective in treatment of chronic pain (low back pain) and disease like the irritable bowel Syndrome. Data about effects on acute pain are spare.
The study investigates the effect of an open-label Placebo (substance without a medical active component) application on acute pain, evoked via a artificial pain model in healthy male volunteers. 32 healthy male volunteers are recruited.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The investigator is blinded about the source of education a participant recieved prior to Placebo application. Investigator is blinded about during which Intervention the Placebo is applicated
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers (American Society of Anaesthesiologist's Class I or II)
- •Body mass index between 18 and 25kg/m2
- •Able to understand the study and the NRS scale
- •Able to give informed consent
排除标准
- •Recreational drug abuse
- •Regularly taking medication potentially interfere with pain sensation (analgesics, antihistamines and calcium and potassium channel blockers)
- •Neuropathy
- •Chronic pain
- •Neuromuscular or psychiatric disease
- •Known or suspected kidney or liver disease
研究组 & 干预措施
Placebo education group
Prior to the intervention during the Placebo is given, the volunteer receives a detailed information about the effect and the strength of an open-label placebo. This education is performed via a slide show and a news report video. The important terms for Placebo analgesia: positive expectations, conditioning, communication are discussed
干预措施: Education (Other)
Placebo non education group
No detailed Information about open-label placebo prior to the intervention. The volunteer is told about the possible strength of the Placebo effect on pain directly before the application.
干预措施: Education (Other)
结局指标
主要结局
Pain response measured by the Area under the Pain Curve (AUPC)
时间窗: 30 minutes after baseline until 100 minutes after baseline
Pain response measured by creating the Area under the Pain Curve (AUPC), using the numeric rating scale (NRS) from minute 30 to 100 during constant induced pain with electrical current at the forearm of the participant. Measuring of pain every 10 minutes from minute 30 to 100 (Minute 30,40,50,60,70,80,90, 100) in an experimental setting. Main comparison: The effect of open label placebo v.s. no treatment intervention
次要结局
- Differences in pain response measured by the AUPC due to education(30 minutes after baseline until 100 minutes after baseline)
- hyperalgesia(100min)
- Saliva cortisol concentration in μg/dL(baseline until 100 min after baseline)
- allodynia(100minutes)