NCT04253860终止3 期
Effect of Transcutaneous Electrical Nerve Stimulation on Pain percepción and Serum Inflammatory Markers in Patients With Peripheral Diabetic Neuropathy
Centro Universitario de Tonalá2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年2月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Pain perception
研究概览
简要总结
Double-blind, randomized, placebo-controlled, clinical trial. Patients with diabetic neuropathy will be randomly assigned to treatment with either TENS or TENS sham three times a week during 90 days. Clinical determinations are: pain, levesls of TNF-alpha, IL-6 and RPC-us
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, Care Provider)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnostic of type 2 diabetes > 10 years
- •Diagnostic of peripheral diabetic neuropathy less than 5 years
- •HbA1C > 6.5 and < 9%
- •Plasmatic glucose >140 mg/dL and lees than 350 mg/dL
- •Informed consent signed
排除标准
- •Use of implanted pacemaker or heart defibrillator
- •Implanted brain stimulator
- •History of alcohol abuse
- •Use of NSAID, stereoids
- •Subjects with wounds, ulcers in legs
- •Subjects with hepatic, renal o neurologic diseases
结局指标
主要结局
Pain perception
时间窗: Change from Baseline Pain perception at 90 days
Evaluation of neuropathic pain evaluated with VAS
次要结局
- Tumoral Necrosis Factor Alpha(Change from Baseline serum levels of TNF-alpha at 90 days)
- C Reactive Protein ultra-sensible(Change from Baseline serum levels of CRP-us at 90 days)
- Interleukin-6(Change from Baseline serum levels of IL-6 at 90 days)
研究者
Arieh Roldán Mercado Sesma
Investigator
Centro Universitario de Tonalá
研究点 (2)
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