Methodological Proposal of Application of Electrical Neurostimulation Transcutaneous (Comparative Study Between Proposed Method of Application Versus Traditional Method in Patients With Primary Dysmenorrhea).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 主要终点
- measure the pain threshold, used to Visual Analogue Scale (VAS)before and after application
研究概览
简要总结
The present study aims to verify the analgesic potential of a new methodological proposal for application for transcutaneous electrical nerve stimulation (TENS interactive) using patients with primary dysmenorrhoea and compare it with placebo in a randomized double blind study with convenience sample.
详细描述
The denouement will be the intensity of pain from visual analogue scale.
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, Outcomes Assessor)
盲法说明
one arm study
入排标准
- 年龄范围
- 18 Years 至 36 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primary dysmenorrhoea
- •Moderate to severe pain
排除标准
- •Secondary dysmenorrhea
- •Users of intrauterine device
- •Cognitive impairment
- •Failure to appear for treatment
- •Pacemaker use
- •Illicit drug use
- •Skin problems
- •Use of pain medication before the application of TENS
研究组 & 干预措施
TENS active
TENS (interactive): frequency (90 and 150 pps) and pulse duration (300 and 400μs)
干预措施: TENS (Device)
TENS sham
Placebo lasting 35 minutes.
干预措施: TENS (sham) (Device)
结局指标
主要结局
measure the pain threshold, used to Visual Analogue Scale (VAS)before and after application
时间窗: participants will be monitored for 24 hours
To assess pain intensity, will be used to Visual Analogue Scale (VAS), Assessments with EVA are performed before and after treatment of interactive TENS (proposed method). All selected volunteers were subjected to an application of TENS (active or sham) in a single menstrual cycle.
次要结局
- duration of analgesia after application(1 week)
研究者
Fabio Mendes Camilo
Methodological Proposal of Application of Electrical Neurostimulation Transcutaneous (Comparative Study between Proposed Method of Application Versus Traditional method in patients with Primary Dysmenorrhea).
Universidade Federal de Sao Carlos