NCT05178589已完成不适用
The Role of Transcutaneous Electrical Nerve Stimulation (TENS) for Menstrual Pain Relief: A Randomized Control Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Analgesic effects of TENS on primary dysmenorrhea.
研究概览
简要总结
The present study aims to verify the analgesic potential of a transcutaneous electrical nerve stimulation (TENS) device using patients with primary dysmenorrhea and compare it with a control period without usage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •History of lower abdominal pain (dysmenorrhea) for more than 6 consecutive menstrual cycles with a moderate or severe pain rating ≥5 out of 10 over course of last year
- •BMI of 18.5-29.9 as a BMI below or above these cut points results in highly varied menstrual cycle lengths
- •Not taking contraception or other types of medication that could influence reproductive status
- •Regular menstruation
- •Medically free from chronic diseases
- •Free from known gynecological problems (ie. Endometriosis, Fibroids, Ovarian Cysts)
- •History of analgesic pill intake during menstruation
- •No pelvic pathology
排除标准
- •Amenorrhea
- •On a form of contraception
- •Secondary dysmenorrhea and/or other gynecological problems that may cause pain
- •No discomfort, pain, or other symptoms during menstruation
- •History of surgery over lower abdomen area
- •Allergy to ibuprofen
- •Cardiac disability
- •Pacemaker
- •Arterial disease
- •Uncontrolled hemorrhage
- •Blood clots
- •Pregnancy or trying to become pregnant
- •Cancerous lesions
- •Exposed metal implants
- •History of seizures
- •Sensory or mental impairment
- •Unstable fractures
结局指标
主要结局
Analgesic effects of TENS on primary dysmenorrhea.
时间窗: 1 month
To determine whether TENS will reduce pain symptoms in those with primary dysmenorrhea. Subjective pain will be assessed using an 11 point visual analog scale (VAS). The scale ranges from 0 to 10, with 0 being no pain and 10 being maximum pain.
次要结局
- Change in analgesic pill consumption during menstruation(1 month)
研究者
Todd Schroeder
Associate Professor of Clinical Physical Therapy
University of Southern California
研究点 (2)
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