A Randomized, Sham Device Controlled, Single Blinded Trial of Portable Transcutaneous Electrical Nerve Stimulation and Heat Therapy Machine in Women With Dysmenorrhea
试验速览
- 阶段
- 3 期
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Change of VAS before and after application of machine
研究概览
简要总结
The hypothesis is that a transcutaneous electrical nerve stimulation and heat therapy machine could reduce dysmenorrhea in women with primary or secondary dysmenorrhea.
详细描述
Inclusion/Exclusion: Described in Eligibility section. Outcome measures: Change of VAS score before and after use of TENS and heat therapy machine.
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 (Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal
- •Moderate or severe dysmenorrhea, mainly in low abdomen area
- •Surgery history on lower abdomen
- •Recent history of cancer
- •TENS device use is contraindicated
- •Ibuprofen use is contraindicated
排除标准
- 未提供
研究组 & 干预措施
Sham
Using not functioning device
干预措施: sham (Device)
Experimental
Using functioning device
干预措施: I RUNE (Device)
结局指标
主要结局
Change of VAS before and after application of machine
时间窗: Immediately before application of machine and 20minutes after application of machine
Measure the change% of VAS between before application of machine (T0) and 20 minutes after application of machine (T20) in every episode of dysmenorrhea during 1 menstrual cycle The mean of change% of VAS is primary outcome measure
次要结局
- BPI score(2nd day of menstrual cycle)