NCT06364592招募中不适用
Effect of Electroacupuncture for Dysmenorrhea Secondary to Adenomyosis: an Exploratory Pilot Study
Guang'anmen Hospital of China Academy of Chinese Medical Sciences1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年7月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The change from baseline in the numerical rating scale (NRS) score on the worst pain
研究概览
简要总结
The aim of this study is to preliminarily evaluate the is to assess the effects and safety of electroacupuncture for moderate to severe dysmenorrhea secondary to adenomyosis.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Meeting the diagnosis criteria of dysmenorrhea secondary to adenomyosis.
- •Female patients aged between 18 and
- •Dysmenorrhea lasting for 3 consecutive menstrual cycles or more.
- •At least three consecutive menstrual cycles with an interval of 24 to 38 days, differing by less than 7 days, and menstrual periods lasting 2 to 8 days before screening.
- •At least 2 days of worst pain score ≥4 on Numerical Rating Scale during the screening period.
- •Having not used medications, other than rescue medicine, or therapies for dysmenorrhea secondary to adenomyosis for at least 1 month before randomization, and consenting not to use throughout the process of the research.
- •Volunteering to participate the trial and signing written informed consent.
排除标准
- •Diagnosed with Endometriosis or having a history of endometriosis-related surgery
- •Currently taking hormonal medications, including: a.use of GnRH agonists within 6 months before the screening period; b. use of progestins or danazol and other long-acting hormones within 3 months before the screening period; c. use of oral contraceptive-like short-acting hormones within one month before the screening period;
- •Having clinically significant gynecologic condition such as clinically significant endometrial pathology, persistent complex ovarian cyst larger than 3 cm or simple ovarian cyst larger than 5 cm, or single fibroid 4 cm or larger or more than 4 fibroids measuring at least 2 cm or symptomatic submucosal fibroid of any size.
- •having an IUD.
- •HB < 90G/L.
- •Having any other chronic pain syndrome that required chronic analgesic or other chronic therapy.
- •Having a current history of undiagnosed abnormal genital bleeding.
- •Malignant tumors (including the reproductive system and other systems).
- •Combined with severe diseases in the cardiac, respiratory, renal, liver, and hematopoietic systems, psychiatric disorder and/or cognitive disorders.
- •Pregnant, breast feeding, planning a pregnancy within the next 7 months.
结局指标
主要结局
The change from baseline in the numerical rating scale (NRS) score on the worst pain
时间窗: The menstruation period of Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5 and Cycle 6 (each cycle is 24-38 days)]
Participants will rate their worst pain during menstruation period of each menstrual cycle on a 0-10 NRS scale, where 0 refers to no pain and 10 refers to the worst pain imaginable. The highest worst pain score of the each cycle will be taken as final NRS score on the worst pain.
次要结局
- The change from baseline in the numerical rating scale (NRS) score on the average pain(The menstruation period of Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 and Cycle 7 (each cycle is 24-38 days)])
- The change from baseline in the numerical rating scale (NRS) score on the worst pain.(The menstruation period of Cycle 1, Cycle 4 and Cycle 7 (each cycle is 24-38 days)])
- The change from baseline in the Pictorial Blood Loss Assessment Chart (PBAC) score.(The menstruation period of Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 and Cycle 7 (each cycle is 24-38 days)])
- The change from baseline in the the Cox Menstrual Symptom Scale (CMSS).(The menstruation period of Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 and Cycle 7 (each cycle is 24-38 days)])
- Proportion of participants with at least 30% reduction of numerical rating scale (NRS) score on average pain.(The menstruation period of Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 and Cycle 7 (each cycle is 24-38 days)])
- Proportion of participants with at least 30% reduction of numerical rating scale (NRS) score on the worst pain.(The menstruation period of Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 and Cycle 7 (each cycle is 24-38 days)])
- The change from baseline in the Short Form Endometriosis Health Profile Questionnaire (EHP-5).(The last week of Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 and Cycle 7 (each cycle is 24-38 days)])
- The change from baseline in the total and sub scores of Hospital Anxiety and Depression Scale (HADS).(The last week of Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 and Cycle 7 (each cycle is 24-38 days)])
研究者
Liu Zhishun
Chief Physician, Dean of Acupuncture Department
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
研究点 (1)
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