Transcutaneous Pulsed Radiofrequency in Diabetic Neurophatic Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baselina in pain on the Visual Analog Scale (VAS) at week 4 and 12
研究概览
简要总结
Investigators want to investigate the efficacy of transcutaneous pulsed radiofrequency therapy in the treatment of diabetic peripheral neuropathy symptoms. For this purpose, investigators aimed to compare the results of two groups treated with sham electrode and active electrode.
详细描述
Peripheral neuropathic pain is common in diabetes mellitus. Distal symmetrical polyneuropathy is the most common form. These patients have complaints such as burning, freezing, tingling and pain in their hands and feet. Peripheral nerve blocks or sympathetic blocks are applied to patients who cannot be treated with medical agents.
Transcutaneous pulsed radiofrequency is a method used in the treatment of pain. The advantages of transcutaneous pulsed radiofrequency method are that it is not invasive, does not cause side effects, and does not interact with drugs. We want to investigate the efficacy of diabetic peripheral neuropathic pain treatment with this method.
Sixty diabetic polyneuropathy patients will be included in the study. Transcutaneous pulsed radiofrequency therapy with active electrode will be applied to half of the patients. Sham electrode will be used for the other half. Patients will not know which group they belong to. Two treatments will be applied with 7 days intervals. The duration of treatment will be 8 minutes.Each patient will receive a Leeds Assessment of Neuropathic Symptoms and Signs questionnaire (LANSS). Before the treatment, in the first month and third month after the treatment, the patients will be filled with a visual analog scale. The results between both groups will be statistically compared.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Diabetes Mellitus
- •Peripheric neuropathy with proved electroneuromyography
排除标准
- •Additional endocrinological disease,
- •Pregnancy, malignancy, motor deficit in lower extremities
结局指标
主要结局
Change from baselina in pain on the Visual Analog Scale (VAS) at week 4 and 12
时间窗: Bseline, week 4 and week 12
The visual analogue scale (VAS) is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain).
次要结局
- Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)(baseline, week4 and week 12)
研究者
Damla Yürük
Director, medical doctor
Diskapi Teaching and Research Hospital