Comparative Effectiveness Of Low Extra-Corporeal Shock Wave Versus Acetylcholine Iontophoresis On Type2 Diabetic Neuropathy: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Electrophysiological investigations of peripheral nerves (latency, amplitude and velocity of peripheral nerves)
研究概览
简要总结
In our thesis, we will compare the effectiveness of low-intensity shock wave versus acetylcholine iontophoresis as a possible new therapy for microcirculation changes in type 2 diabetic neuropathy
详细描述
Methods: A group of 80 patients (male and female) diagnosed with type 2 diabetes mellitus, was included in the study. Their age ranged from 40-60 years. Patients randomly will be divided into two groups: Study groups (A) 40 patients with type 2 diabetes mellitus with clinically proven peripheral neuropathy. And study group (B) 40 patients with type 2 diabetes mellitus with clinically proven peripheral neuropathy. They were selected from South Valley University Hospitals. Group A received low-intensity extracorporeal shock wave therapy Li-ESWT (3 Hz, 0.09 mJ/mm2, 300 pulses), for two sessions per week for six weeks. Study group (B) received iontophoresis by acetylcholine current intensity of 3 to 5 mA. Check skin every 3-5 minutes for signs of skin irritation with (15) min for three sessions per week for four weeks. Nitric oxide level and the electrophysiology (EMG) of peripheral nerves and muscles were measured pre and post-treatment.
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
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients have to be symptomatically stable with type 2 diabetes mellitus complicated with peripheral neuropathy.
- •Optimized pharmacological treatment that will be remained unchanged throughout the study.
排除标准
- •Implanted cardiac pacemakers.
- •Patients with known skin allergies.
- •Presence of skin inflammations.
- •Peripheral vascular disease.
- •Patients with unstable angina pectoris.
- •Progressive ventricular dysrhythmia.
- •Intermittent claudication.
结局指标
主要结局
Electrophysiological investigations of peripheral nerves (latency, amplitude and velocity of peripheral nerves)
时间窗: Six weeks
Electrophysiological investigations of peripheral nerves were measured pre and post treatment for both groups (latency, amplitude and velocity of peripheral nerves)
次要结局
- Nitric oxide laboratories for measurement of nitric oxide level(Six weeks)
研究者
Ibrahim Abuzaid
Director, Head of Department of Physiotherapy for Cardiovascular/Respiratory and Geriatrics
South Valley University