Pain After Deep Electrical Stimulation in the Groin in Pain Free Subjects (HADES-1)
Hyperalgesia After Deep Electrical Stimulation in Pain Free Subjects
研究概览
地位
研究类型
注册 (实际的)
联系人和位置
学习地点
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Copenhagen、丹麦、2100
- Section for Surgical Pathophysiology, Rigshospitalet
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- male, age >18 yr, pain-free, caucasian
Exclusion Criteria:
- previous groin surgery, groin hernia, sensory disturbaces, use of painmedication, drug or alcohol abuse.
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:预期
队列和干预
团体/队列 |
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1
1. Healthy, un-operated, groin-hernia free, pain-free and medicinal free males
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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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Change in skin pain detection threshold before and during deep electrical pain stimulation.
大体时间:14 days
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Heat pain detection threshold by use of a Thermotester (Somedic AS Sweden) is assessed before and during deep electrical pain stimulation (6 of 10 point on a NRS scale. Deep pain stimulation is performed by two needle electrodes, placed under ultrasound guidance, 5 mm apart in various tissue and locations in the groin:
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14 days
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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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Test-retest of primary outcome
大体时间:14 days
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The primay and additional assesments are re-measured 14 days after the primary assemssment to allow evaluation of test-retest reliability.
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14 days
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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deep electrical and pain detection thresholds
大体时间:14 days
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The detection- and pain detection thresholds to electrical stimulation will be assessed. An up-n-down staircase stimulation of single oulses of 0.04 mSeconds with increasing mA from 0.1 to a maximum of 60 mA is used. A total of 10 thresholds is recorded in the following locations. Musculus rectus abdominis dxt. ( 10 cm craniel to the external inguinal ring) - Subcutaneous, and muscular stimulation. Spina iliaca anterior superior dxt. ( 2 cm lateral to the ilica spine) - subcutaneous, m obliquus externus and nervns ilioinguinalis stimulation. External inguinal ring - subcutaneous and funicle stimulation. Musculus rectus abdominis sin. ( 10 cm craniel to the external inguinal ring) - Subcutaneous, and muscular stimulation. |
14 days
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warmth and mechanical detection and pain detection thresholds
大体时间:14 days
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warmth and mechanical detection and pain detection thresholds are recorded in the right and left groin and right lower arm.
A total of 10 repated mesures for each parameter is recorded.
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14 days
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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