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临床试验/NCT01372020
NCT01372020已完成4 期

The Effect of Neuromuscular Electrical Therapy on Pain in Patients With Venous Ulcers: a Controlled Clinical Trial

Faculdade Evangelica do Parana2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年2月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Pain

研究概览

简要总结

The use of neuromuscular electrical stimulation in the treatment of venous ulcers with difficulty of repair could be an alternative therapeutic favoring devitalized tissues and hence the pain.

The aim of this study is to evaluate the effect of neuromuscular electrical stimulation on pain and area of venous ulcers in patients with venous insufficiency.

详细描述

The aim was to evaluate the effect of neuromuscular electrical stimulation on pain and area of venous ulcers in patients with venous insufficiency. In a simple-blind controlled clinical study, 20 subjects with venous ulcers with age over 50 years will be divided in two groups:neuromuscular electrical stimulation(n=10) and control group (n=10). Pain (by Visual Analogue Scale) and the ulcer area (by planimetry on graph paper and the software ImageJ ®) were measured.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects of both genders
  • aged over 50 years
  • sedentary and with clinical diagnosis of chronic venous insufficiency with ulcer in lower limbs will be included

排除标准

  • Subjects with pacemakers
  • uncontrolled hypertension
  • osteomyelitis and pain of unknown origin
  • unable to walk or make use of drugs that acted directly on the healing process will be excluded

结局指标

主要结局

Pain

时间窗: the subjects will be followed for a period of 4 weeks.

Pain assessment will be performed by the Visual Analogue Scale

次要结局

  • ulcer area(the patients will be folloed for the 4-weeks.)

研究者

发起方
Faculdade Evangelica do Parana
申办方类型
Other
责任方
Principal Investigator
主要研究者

Silvia Valderramas

Silvia Valderramas

Faculdade Evangelica do Parana

研究点 (2)

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