A Randomized, Controlled, Multi-Center, CROSSOVER, Prospective, Double-blind Clinical Study to Assess the Effectiveness and Safety of Livia® Transcutaneous Electrical Nerve Stimulation (TENS) in Women Suffering From Primary Dysmenorrhea
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- The difference between the reported Visual Analogue Scale before and after applying the device (active or sham).
研究概览
简要总结
This is a randomized, controlled, multi-center, single-arm, crossover, double-blind clinical study assessing the Livia Transcutaneous Electrical Nerve Stimulation (TENS) in women suffering from dysmenorrhea. The study will be conducted at community clinics. Advertisement will be used to publish and promote recruitment.
The study will include 3 visits: Screening visit and two consecutive visits each one after monthly menstrual period. Treatment will be self-administrated and during the study, the subjects will be requested to complete home diaries.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between the age 18 to 45 years
- •Women reporting painful menstruation during the last 3 menstrual cycles.
- •Pain VAS score of at least 60 based on previous menstrual cycle
- •Subject is willing and able to comply with the study protocol and provide written informed consent to participate in the study.
- •Subject must agree to consistently use effective contraception throughout the study. (Subject not treated with oral contraception should use any contraception other than oral).
排除标准
- •Participation in any other investigational study within 30 days prior and/or at the date of subject consent.
- •Woman with a significant medical condition such as: cancer, diabetes (Type I and II), irritable bowel disease IBD, immunodeficiency, autoimmune disease, etc. that in the investigator opinion, participation in the study would place the patient at an unacceptable risk.
- •Pregnant woman
- •A woman who is diagnosed with secondary dysmenorrhea associated with uterine myomas, endometriosis, adenomyosis, etc.
- •A woman who has cardiac condition with cardiac pacemakers, implanted defibrillators, or other implanted metallic or electronic devices.
研究组 & 干预措施
Shame device
干预措施: Livia (Device)
Livia® Transcutaneous Electrical Nerve Stimulation (TENS)
干预措施: Livia (Device)
结局指标
主要结局
The difference between the reported Visual Analogue Scale before and after applying the device (active or sham).
时间窗: 3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period.
Each participant will rank the severity of her dysmenorrhea symptoms before and after the device use on the VAS scale from 0 to 100, where 0 determines- "No pain" and 100 determines "Very painful". Then, the difference between the two measurements will be calculated.
次要结局
- Usage of pain relievers during the menstrual period(3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period.)
- Quality of life(3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period.)
- The convenience of device operation(3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period.)