跳至主要内容
临床试验/NCT01888783
NCT01888783Unknown不适用

Comparison of Two Measures of Tactile Acuity in CRPS Type I Patients , Patients With a Neuropathy of the Median Nerve and Healthy Controls.

Ruhr University of Bochum2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2012年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
2
主要终点
tactile acuity as measured by 2-point-discrimination

研究概览

简要总结

This study aims to investigate whether two different measures of tactile acuity lead to comparable results in patients diagnosed with CRPS Type I of the upper extremity. Additionally patients with a neuropathy of the median nerve and healthy controls are included.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with CRPS Type I according to the "Budapest Criteria"
  • Patients diagnosed with a neuropathy of the median nerve
  • Healthy Controls,matched in age and gender to both patient cohorts

排除标准

  • intolerable hyperalgesia
  • lesions at the fingertips
  • high grade digit contracture
  • central neurologic disorders
  • psychiatric disorders

结局指标

主要结局

tactile acuity as measured by 2-point-discrimination

时间窗: unique measurement of maximal one hour duration

Thresholds on the tip of the index finger of boths hands are assessed using the method of constant stimuli. One single needle and seven pairs of needles with different spacings are tested in randomized order. After each presentation, the subject has to report the sensation of one or two needles by answering immediately "one" or "two." Each distance is presented eight times resulting in 64 single decisions. The summed responses are plotted against distance as a psychometric function for absolute threshold and get fitted by a binary logistic regression. Thresholds are taken from the fit at the distance at which 50% correct answers are given

tactile acuity as measured by the Grating Orientation Task (GOT)

时间窗: unique measurement of maximal half an hour duration

Stimuli are taken from a set of dome-shaped plastic gratings with equal groove and ridge widths. Gratings are applied to the immobilized distal fingerpad of the index finger of boths hand with the ridges oriented either along or across the long axis of the finger in randomized sequences of the two alternatives. Subjects have to report the orientation of the gratings as "along" or "across". The largest groove widths in the set is 6mm, the minimal width is 0.5mm. Thresholds were taken from the groove width at which the performance was 75% correct. Unless the performance is exactly 75% for a particular grating, interpolation between gratings spanning the 75% correct responses ared used

次要结局

未报告次要终点

研究者

发起方
Ruhr University of Bochum
申办方类型
Other
责任方
Principal Investigator
主要研究者

Christoph Maier, Prof. Dr.

Prof. Dr. med Christoph Maier, Head Dep. of Pain Medicine

Ruhr University of Bochum

研究点 (2)

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