Individualized Acupoint Therapy for Dysmenorrhea: An Exploratory Research Design and Feasibility Assessment Based on Meridian Measurement
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Dysmenorrhea Pain Severity via Visual Analog Scale (VAS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •Major Gynecological Conditions:
- •History of major gynecological disorders.
- •Confirmed diagnosis of structural or organic gynecological conditions, including endometriosis, uterine fibroids, or polycystic ovary syndrome (PCOS).
- •Pharmacological Interference:
- •Long-term use of medications that affect the menstrual cycle.
- •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.
研究组 & 干预措施
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.
干预措施: TI-816-3E3 Portable Laser Phototherapy Device (Device)
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.
干预措施: TI-816-3E3 Portable Laser Phototherapy Device (Device)
结局指标
主要结局
Change in Dysmenorrhea Pain Severity via Visual Analog Scale (VAS)
时间窗: 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).
次要结局
- Change in Menstrual Distress Symptoms via Moos Menstrual Distress Questionnaire (MDQ Form C)(Baseline (Pre-treatment), Mid-treatment (Week 2 of intervention), and Post-treatment (Week 4, immediately following intervention completion).)
- Change in Meridian Electrical Resistance Profiles(Baseline (Pre-treatment), Mid-treatment (Week 2 of intervention), and Post-treatment (Week 4, immediately following intervention completion).)