Effect of Semiconductor Embedded Wearable Sleeve on the Treatment and Mitigation of Primary Dysmenorrhea Symptoms: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Participant-Reported Changes in Pain
研究概览
简要总结
This study is looking to test a non-compressive semiconductor embedded body sleeve for treatment of primary dysmenorrhea symptoms. Dysmenorrhea is the lower abdominal pain (sometimes referred to as "cramping") experienced during menstruation (monthly "period"), affecting up to 94% of people aged from 10-20 years old. The semiconductor embedded fabric increases blood circulation through activation of the embedded elements with body heat while worn and releases energy waves as well as negative ions. This energy has an effect inside the body that increases oxygen and nutrient flow to tissues, and can help to decrease pain and inflammation. This study is testing this technology to see if it can be used as a non-pharmacological treatment for menstrual cramping.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Self-reported primary dysmenorrhea during past three menstrual cycles
- •Age 18-45 inclusive at the time of consent
- •Self-reported typical primary dysmenorrhea symptom pain greater than 4 on a 1-10 visual analog scale (VAS)
- •History of regular menstrual cycles with a usual length of 21 to 35 days
- •Willing and able to provide informed consent and adhere to study requirements
排除标准
- •History of neurological conditions, including multiple sclerosis or Parkinson's disease
- •Secondary dysmenorrhea including confirmed or suspected endometriosis or fibroids or intrauterine device
- •Self-reported size not available in study device
- •Pregnant or planning to become pregnant during the study
- •Have within the past six months of enrollment, or are planning to in the next six months, start or discontinue any of the following contraceptive methods:
- •intrauterine device
- •oral contraceptives,
- •contraceptive patch,
- •implant (Nexplanon),
- •shot (Depo-Provera),
- •vaginal ring
- •Chronic pain conditions unrelated to primary dysmenorrhea
- •Auto-immune or auto-inflammatory diseases
- •Has used within the last 90 days or is planning to use nicotine-containing products
- •History of metabolic disorders
- •Active infection (local or systemic) that, in the opinion of the investigator, would prevent usage of the device
- •In the opinion of the investigator, any other criteria or condition that could increase the risk associated with study participation or study treatment or could interfere with the interpretation of study results
- •Have taken any investigational drug or used any investigational device within the 30 days prior to consent.
研究组 & 干预措施
Placebo Device
Identical device absent of semiconductors
干预措施: Placebo Non-Compressive Body Sleeve (Device)
Active Device
Device embedded with semiconductors
干预措施: Semiconductor embedded body sleeve (Device)
结局指标
主要结局
Participant-Reported Changes in Pain
时间窗: 6 months
Reduction in menstrual symptom severity as determined by the Visual Analog Scale (VAS) compared to placebo group: Visual Analog Scale for Pain (VAS) Minimum value: 0 (no pain) Maximum value: 10 (worst possible pain)
次要结局
- Participant-Reported Changes in Quality of Life(6 months)
- Changes in participant function in daily life(6 months)
- Changes in menstrual symptom duration(6 months)
- Changes in oral medication intake compared to placebo group(6 months)
- Changes in Participant Pain Score (SF-MPQ-2)(6 months)
研究者
Anne Flynn, MD
Assistant Clinical Professor
University of California, Davis