NCT06914752撤回不适用
TENS for Endometriosis Pain in Adolescents and Young Adults
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain - Visual Acuity Scale
研究概览
简要总结
The goal of this project is plan to investigate the utility of Transcutaneous Electrical Nerve Stimulators (TENS) for the reduction of pain and the improvement of quality of life in adolescents and young adults with chronic pelvic pain related to endometriosis.
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
- 10 Years 至 21 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adolescent girls and young women (13-25)
- •Diagnosis of endometriosis,
- •Current pelvic pain (score ≥ 3 on Visual Analog Scale, where 0 represents absence of pain and 10 indicates unbearable pain) present for ≥ 14 days/month over the 2 months prior to study enrollment.
- •Personal smart phone or mobile device
- •Speak either English or Spanish.
排除标准
- 未提供
研究组 & 干预措施
Delayed Intervention
Experimental
干预措施: TENS (Device)
Immediate intervention
Experimental
干预措施: TENS (Device)
结局指标
主要结局
Pain - Visual Acuity Scale
时间窗: 6 months
Pain on a scale of 0-10, where a higher score indicates worse pain.
次要结局
- Endometriosis Health Profile 30 (EHP-30)(6 months)
- Missed school/work(6 months)
研究者
Elizabeth Boskey
Co-Director of Research, Division of Gynecology
Boston Children's Hospital
研究点 (1)
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