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Individualized Acupoint Therapy for Dysmenorrhea: An Exploratory Research Design Based on Meridian Measurement

2026年9月9日 更新者：China Medical University Hospital

Individualized Acupoint Therapy for Dysmenorrhea: An Exploratory Research Design and Feasibility Assessment Based on Meridian Measurement

Primary dysmenorrhea is a common condition that significantly affects young women's quality of life. Traditional Chinese Medicine (TCM) acupoint interventions are widely used for symptom relief; however, standardized fixed-acupoint approaches often overlook individual meridian status variations.

This pilot study aims to evaluate the feasibility, preliminary efficacy, and physiological responses of an individualized meridian-guided intervention for primary dysmenorrhea in females aged 18-30. Utilizing non-invasive skin electrical resistance measurements (AETOSCAN) to assess baseline meridian energy status, eligible dysmenorrhea participants will be randomized into two parallel arms: an individualized meridian-guided intervention group and a standardized fixed-acupoint group. Interventions will be administered twice weekly over a 4-week cycle. The primary outcomes focus on changes in pain severity (VAS), menstrual distress scores (MDQ), and objective meridian electrical characteristics.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 台湾
      • Taichung、台湾、404327
        • China Medical University Hospital
        • 接触：
        • 首席研究员：
          • Yu-Chen Lee

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

是的

描述

Inclusion Criteria:

  • 20 female participants with a history of primary dysmenorrhea symptoms.
  • 20 healthy female controls without significant dysmenorrhea symptoms.
  • Age Range: Females aged 18-30 years.
  • Menstrual Regularity: Regular menstrual cycles, defined as a cycle duration of 21-35 days.
  • Menstrual Stability: Relatively stable menstrual patterns within the past 3 months.
  • Informed Consent & Compliance: Willingness to comply with all measurement and intervention protocols, and provided signed written informed consent.
  • Medication Management: Agreeing not to use additional analgesics or traditional conditioning treatments during the intervention period (or agreeing to accurately report and record any use).

Exclusion Criteria:

  • Major Gynecological Conditions:

    1. History of major gynecological disorders.
    2. Confirmed diagnosis of structural or organic gynecological conditions, including endometriosis, uterine fibroids, or polycystic ovary syndrome (PCOS).

  • Pharmacological Interference:

    1. Long-term use of medications that affect the menstrual cycle.
    2. Currently undergoing hormonal therapy or long-term administration of analgesics.
  • Physiological States: Pregnancy or current breastfeeding.
  • General Health Status: Recent acute systemic inflammation or major systemic illnesses.
  • Prior Treatment Confounding: Recent receipt of intensive acupuncture, moxibustion, or related meridian-based therapies.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器：Active Control: Standard Acupoint Group
Participants in this arm receive standardized, fixed-acupoint laser acupuncture (or sham-like press-needle/seeding on standard dysmenorrhea points such as SP6, CV4, CV6) regardless of their individual meridian electrical resistance profile.
设备：TI-816-3E3 Portable Laser Phototherapy Device
Application of low-level laser acupuncture on predefined classic acupoints (SP6, CV4, CV6) for 20 minutes per session, twice per week for 4 consecutive weeks.
设备：TI-816-3E3 Portable Laser Phototherapy Device
Application of low-level laser acupuncture tailored to individual meridian imbalance profiles identified by AETOSCAN, for 20 minutes per session, twice per week for 4 consecutive weeks.
实验性的：Experimental: Individualized Meridian-Guided Group
Participants in this arm receive individualized laser acupuncture based on real-time meridian electrical resistance measurements using AETOSCAN prior to each intervention session.
设备：TI-816-3E3 Portable Laser Phototherapy Device
Application of low-level laser acupuncture on predefined classic acupoints (SP6, CV4, CV6) for 20 minutes per session, twice per week for 4 consecutive weeks.
设备：TI-816-3E3 Portable Laser Phototherapy Device
Application of low-level laser acupuncture tailored to individual meridian imbalance profiles identified by AETOSCAN, for 20 minutes per session, twice per week for 4 consecutive weeks.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Dysmenorrhea Pain Severity via Visual Analog Scale (VAS)
大体时间：Baseline (Pre-treatment), Mid-treatment (Week 2 of intervention), and Post-treatment (Week 4, immediately following intervention completion).

The Visual Analog Scale (VAS) is a 0-100 mm continuous scale used to measure subjective menstrual pain severity (0 = no pain, 100 = worst imaginable pain). Higher scores indicate greater pain intensity.

Time Frame: Baseline (Pre-treatment), Mid-treatment (Week 2 of intervention), and Post-treatment (Week 4, immediately following intervention completion).
Baseline (Pre-treatment), Mid-treatment (Week 2 of intervention), and Post-treatment (Week 4, immediately following intervention completion).

次要结果测量

结果测量
措施说明
大体时间
Change in Menstrual Distress Symptoms via Moos Menstrual Distress Questionnaire (MDQ Form C)
大体时间：Baseline (Pre-treatment), Mid-treatment (Week 2 of intervention), and Post-treatment (Week 4, immediately following intervention completion).
The MDQ Form C consists of 46 items across 8 subscales assessed on a 5-point Likert scale (0 = no symptom to 4 = severe symptom). Total scores range from 0 to 184, with higher scores reflecting greater menstrual distress.
Baseline (Pre-treatment), Mid-treatment (Week 2 of intervention), and Post-treatment (Week 4, immediately following intervention completion).
Change in Meridian Electrical Resistance Profiles
大体时间：Baseline (Pre-treatment), Mid-treatment (Week 2 of intervention), and Post-treatment (Week 4, immediately following intervention completion).
Objective skin electrical resistance (in microamperes, µA) measured across twelve primary meridian Yuan-Source points using the AETOSCAN system to assess systemic physiological energy shifts.
Baseline (Pre-treatment), Mid-treatment (Week 2 of intervention), and Post-treatment (Week 4, immediately following intervention completion).

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

China Medical University Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2027年8月31日

研究完成 (估计的)

2027年8月31日

研究注册日期

首次提交

2026年9月9日

首先提交符合 QC 标准的

2026年9月9日

首次发布 (实际的)

2026年9月14日

研究记录更新

最后更新发布 (实际的)

2026年9月14日

上次提交的符合 QC 标准的更新

2026年9月9日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • CMUH115-REC2-152

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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