Monitoring Effect Of Shock Wave On Microcirculation Changes In Type2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- • Numerical Rating Pain Scale
研究概览
简要总结
The purpose of the study is to monitor the effect of low intensity extracorporeal shock wave therapy on impaired nitric oxide synthase and microcirculation changes in type 2 diabetes mellitus with peripheral neuropathy.
详细描述
Low-intensity extracorporeal shockwave therapy (Li-ESWT) improved peripheral nerve repair and regeneration. Li-ESWT exerts its biological effects by increasing neuro¬trophic factors, Schwann cell activation, and cellular signaling activation. Li-ESWT could be a novel treatment for nerve injury-induced diabetic neuropathy and other conditions related to nerve in¬jury.
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)
盲法说明
A group of 80 patients (male and female) diagnosed as type 2 diabetes mellitus, will be included in the study. Their age will be ranged from 40-60 years. Their weight ranged from 80 - 100 k.g. and their height ranged from 160 - 180 cm. Patients will divide into two groups: Study groups (A) 40 patients type 2 diabetes mellitus with clinically proved peripheral neuropathy. And control group (B) 40 patients with asymptomatic type 2 diabetes mellitus. They will be selected from South valley university hospitals. Group A will receive low intensity extracorporeal shock wave therapy for two per week for four weeks. Group B will receive shame low intensity extracorporeal shock wave therapy.
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.
研究组 & 干预措施
Monitoring Effect Of Shock Wave On Microcirculation Changes In Type2 Diabetes Mellitus
Energy intensity of (0.09 mJ/mm2) for 12 treatment sessions, two per week, for six weeks
干预措施: Low intensity extracorporeal shock wave (Device)
Effect Of Shock Wave On Microcirculation Changes In Type2 Diabetes Mellitus
low intensity extracorporeal shock wave with the following parameters: - 3000 SWs (energy intensity of (0.09 mJ/mm2).
干预措施: Low intensity extracorporeal shock wave (Device)
结局指标
主要结局
• Numerical Rating Pain Scale
时间窗: six weeks
• The Numerical Rating Scale (NRS) is designed for anyone over age 9. It is one of the most commonly used pain scales in health care. To use it, you just say the number that best matches the level of pain you are feeling; you can also place a mark on the scale itself. Zero means you have no pain, while 10 represents the most intense pain possible.
• Nitric oxide level and electrophysiological investigations of peripheral nerves and muscles was measured pre and post treatment.
时间窗: six weeks
1\. Laboratory methods: Nitric oxide laboratories for measurement of nitric oxide level.3. Electrodiagnostic studies are sensitive, specific, and validated measures of the presence of polyneuropathy.
次要结局
未报告次要终点
研究者
Ibrahim Abuzaid
Head of the Department of Physiotherapy for Cardiovascular/ Rspiratory disorder and Geriatrics
South Valley University