Extracorporal Shock Wave Treatment After Microsurgical Coaptation to Improve Nerve Regeneration
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Two Point Discrimination
研究概览
简要总结
This study evaluates the impact of extracorporeal shock wave treatment after microsurgical coaptation of finger nerves. Participants will be randomized into two treatment groups with different settings and a sham group. The participants will thereafter followed-up in a prospective, double-blind study design.
详细描述
Extracorporeal shock wave treatment is CE certified in Austria, Europe and licensed for indications like achillodynia, epicondylitis, or tendinitis calcanea. The Orthogold 100 device by MTS Medical UG will be used for this study.
Defocused low-energy extracorporeal shock wave therapy (ESWT) has gained acceptance as a therapeutic tool in different medical settings. It has been shown, that shock waves stimulate of the metabolic activity of different cell type, including osteoblasts, tenocytes, endothelial cells and chondrocytes. Furthermore, it has proved effective in clinical applications relating to bone and wound healing and myocardial ischaemia. Until now, no studies have been performed regarding the effects of ESWT on regeneration of peripheral nerve injuries in humans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The participant will be wearing an acoustic and visual masking. The outcome assessor won't know if the participant was treated or if he was assigned to the sham group.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •complete lossless transection of one or more digital nerves distal to the branching out of the commune median or ulnar nerves
- •direct, tension-free coaptation of the nerve stumps
排除标准
- •segment loss of the nerve
- •tension after direct coaptation
- •diabetic neuropathy or other peripheral neuropathies
- •other disease with reduced sensibility of the fingers
- •injuries in the course of the nerve (plexus brachialis, median or ulnar nerve)
- •chronic inflammatory disease
- •rheumatoid arthritis
- •pregnancy
- •patients not able to give written consent
- •patients with an implantable cardiac defibrillator or pacemaker
- •patients which are sensitive to electromagnetic radiance
结局指标
主要结局
Two Point Discrimination
时间窗: 1 year
Two Point Discrimination distal of the nerve lesion in mm
Semmes Weinstein Monofilament test
时间窗: 1 year
Palpable Monofilaments, measured in Newton
Pain/Discomfort
时间窗: 1 year
0=Hinders function 1=Disturbing 2=Moderate 3=None/minor
hyperesthesia
时间窗: 1 year
0=Hinders function 1=Disturbing 2=Moderate 3=None/minor
次要结局
- Tinel Hoffmann sign(1 year)
- Sonography(1 year)
- velocity of nerve conduction(1 year)
- Medical Research Council Grading of Sensibility(1 year)
研究者
Rudolf Rosenauer
Principal investigator
Ludwig Boltzmann Gesellschaft