NCT01345994Unknown早期 1 期
Brain Plasticity in Carpal Tunnel Syndrome and Its Response to Acupuncture
Martinos Center for Biomedical Imaging2 个研究点 分布在 1 个国家开始时间: 2009年5月1日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 发起方
- 试验地点
- 2
- 主要终点
- Functional MRI brain response
研究概览
简要总结
This study will characterize brain plasticity in Carpal Tunnel Syndrome and will determine how this central fMRI biomarker is modulated by acupuncture. This study will also investigate the behavioral consequences of maladaptive cortical plasticity in this disease population.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female adults aged 20-
- •Pain and/or paresthesia in median nerve distribution (i.e., numbness in some combination of digit 1, 2, 3, and the radial part of digit 4)
- •Nocturnal pain and/or paresthesia in median nerve distribution
- •Symptoms (a and b) greater than 3 months in duration
- •Physical Exam with two of the following three findings:
- •Phalen's and Durkin's sign (positive with paresthesia in at least 1 of 3 radial digits)
- •Abnormal grip strength (greater than 2 S.D. compared to uninvolved side using an isometric hand grip device)
- •Nerve conduction findings consistent with mild to severe CTS:
- •Mild CTS: Delayed distal latency of the sensory nerve conductions across the wrist (> 3.7milliseconds and/or > than 0.5 milliseconds compared to the ulnar sensory conduction) with normal motor conductions
- •Moderate CTS: Delayed distal latency of the sensory nerve conductions across the wrist as stated above with delayed distal latency of the motor conductions across the wrist (> 4.2 milliseconds).
- •Severe CTS: Delayed distal latency of the sensory nerve conductions across the wrist as stated above with greater than 50% loss of motor amplitudes (relative to unaffected side and/or normative range).
排除标准
- •Contraindications to MRI examination (pregnancy, pacemaker, etc. according to guidelines set by MGH NMR-Center)
- •History of diabetes mellitus or other major cardiovascular, respiratory, or neurological illnesses.
- •History of rheumatoid arthritis.
- •History of wrist fracture with direct trauma to median nerve.
- •Current usage of prescriptive opioid pain medication.
- •Severe thenar atrophy.
- •Nerve entrapment other than median nerve.
- •Cervical radiculopathy or myelopathy.
- •Generalized peripheral neuropathy.
- •A blood dyscrasia or coagulopathy or current use of anticoagulation therapy
结局指标
主要结局
Functional MRI brain response
时间窗: Baseline vs. Post-Acupuncture (average 9 weeks later)
Several fMRI outcomes will be assessed including brain hyperactivity and somatotopy
次要结局
未报告次要终点
研究者
研究点 (2)
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