Pain Response to Open Label Placebo in Induced Acute Pain in Healthy Male Adults (POLAP)
2018年5月15日 更新者：University Hospital, Basel, Switzerland
Pain Response to Open Label Placebo in Induced Acute Pain in Healthy Male Adults - A Randomized Single Blinded Clinical Trail
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.
研究概览
研究类型
介入性
注册 (实际的)
35
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Basel Stadt
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Basel、Basel Stadt、瑞士、4031
- University Hospital Basel
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
男性
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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其他：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
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c.p. intervention description
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其他：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.
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c.p. intervention description
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Pain response measured by the Area under the Pain Curve (AUPC)
大体时间：30 minutes after baseline until 100 minutes after baseline
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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
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30 minutes after baseline until 100 minutes after baseline
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Differences in pain response measured by the AUPC due to education
大体时间：30 minutes after baseline until 100 minutes after baseline
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The pain response measured by the AUPC in participants received a detailed education about open label Placebo compared to those who received a short education direct prior to placebo administration.
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30 minutes after baseline until 100 minutes after baseline
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hyperalgesia
大体时间：100min
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Hyperalgesia will be measured analogously to the NRS
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100min
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Saliva cortisol concentration in μg/dL
大体时间：baseline until 100 min after baseline
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Saliva concentration of cortisol, will be measured 4 times: at baseline, 30, 60 and 100 minutes during pain induction
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baseline until 100 min after baseline
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allodynia
大体时间：100minutes
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allodynia will be measured analogously to the NRS
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100minutes
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Wilhelm Ruppen, PD、Dep. Anesthesiology University Hospital Basel
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年11月11日
初级完成 (实际的)
2018年3月30日
研究完成 (实际的)
2018年3月30日
研究注册日期
首次提交
2017年11月17日
首先提交符合 QC 标准的
2017年11月28日
首次发布 (实际的)
2017年12月5日
研究记录更新
最后更新发布 (实际的)
2018年5月16日
上次提交的符合 QC 标准的更新
2018年5月15日
最后验证
2018年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Education的临床试验
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