Comparison of Two Measures of Tactile Acuity in CRPS Type I Patients , Patients With a Neuropathy of the Median Nerve and Healthy Controls.
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
- 是
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
Christoph Maier, Prof. Dr.
Prof. Dr. med Christoph Maier, Head Dep. of Pain Medicine
Ruhr University of Bochum
