Treatment of Dysmenorrhoea With the OVA TENS Apparatus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in VAS pain score
研究概览
简要总结
Dysmenorrhoea (menstrual pain) is a common complaint among women, leading to use of analgesics, reduced quality of life, and interference with daily activities such as going to work or school.
Transcutaneous electrical nerve stimulation (TENS) is a well established method for treatment of pain. Several clinical studies have shown TENS treatment to be effective against dysmenorrhoea. A TENS apparatus specifically developed for the treatment of dysmenorrhoea has now become commercially available (OVA), but is has not been tested in clinical studies.
This study will be done to evaluate the clinical utility of treatment with OVA in women with primary dysmenorrhoea.
详细描述
Study aims: To compare perception of dysmenorrhoea with and without use of OVA.
Design: Prospective, clinical study lasting four months. The women will use the OVA apparatus during every other menstruation.
Inclusion: 20 female volunteers with primary dysmenorrhoea.
Exclusion: Pregnancy, either ongoing or planned during the study period. Secondary dysmenorrhoea.
Consent: The participants will receive verbal and written information and will sign a consent form.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Primary dysmenorrhoea
排除标准
- •Pregnancy
结局指标
主要结局
Change in VAS pain score
次要结局
未报告次要终点