To Prove the Effectiveness of PENS Therapy With Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Reduction of Neuropathy pain
研究概览
简要总结
To prove the effectiveness of Percutaneous Electrical Neuro-stimulation therapy for the treatment of conditions associated with peripheral neuropathy, in a double-blind environment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
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
- 否
入选标准
- •Patients with Neuropathy pain
排除标准
- •Patient with inbuilt pacemakers or any other devices which allows current into the body, pregnant ladies.
研究组 & 干预措施
Standard stimulation
Group A will be treated with First Relief Treatment at standard stimulation.
干预措施: First Relief Treatment (Device)
sweep stimulation
Group B will be treated with First Relief Treatment at sweep stimulation.
干预措施: First Relief Treatment (Device)
Placebo
Group C will be treated with First Relief Treatment, receiving a placebo.(dummy device with no electrical stimulation)
干预措施: First Relief Treatment (Device)
结局指标
主要结局
Reduction of Neuropathy pain
时间窗: According to the patients condition and other factors expected to reduce pain in 4th week of the treatment
This treatments effective outcome will be, "Percutaneous Electrical Nerve Stimulation therapy will have the ability to reduce the pain and other conditions regarding peripheral neuropathy" which can be verified through "Biothesiometer" parameters.
次要结局
- Check for delay of Re-occurrence of pain within a short time(90 Days)