Evaluating the Analgesic Efficacy of Suspended Moxibustion in the Treatment of Primary Dysmenorrhea in Female Students at Can Tho University of Medicine and Pharmacy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change in Visual Analogue Scale (VAS) pain score
研究概览
简要总结
This study evaluates the analgesic efficacy of suspended moxibustion applied at acupoints CV4 (Guanyuan), CV8 (Shenque), and bilateral SP6 (Sanyinjiao) in female students with primary dysmenorrhea at Can Tho University of Medicine and Pharmacy. In this single-arm pre-post clinical intervention (N=48), participants received daily 20-minute moxibustion sessions starting 7 days before menstruation through the end of the menstrual period, across three consecutive treatment cycles. The primary outcome was change in VAS pain score; secondary outcomes included RSS-COX symptom burden, number of pain days per cycle, and abdominal skin temperature measured by thermal imaging (FLIR C5).
详细描述
Primary dysmenorrhea (PD) affects up to 88.2% of female students at Can Tho University of Medicine and Pharmacy, yet fewer than 10% receive structured treatment. Moxibustion, a traditional Chinese medicine thermal therapy, has shown promise in regulating prostaglandin synthesis and improving uterine microcirculation, but no controlled study had previously evaluated a standardized moxibustion protocol in Vietnamese medical students.
Eligible participants were female students and postgraduate trainees aged 18-35 years with regular menstrual cycles (28±7 days) and a history of moderate-to-severe dysmenorrhea (VAS ≥ 4) in at least 3 consecutive cycles prior to enrolment. Exclusion criteria included secondary dysmenorrhea, neurological or bleeding disorders, use of prostaglandin synthesis inhibitors within 2 weeks of enrolment, pregnancy/lactation, and current use of NSAIDs or oral contraceptives.
Suspended moxibustion (moxa stick held 2-3 cm above skin, target skin temperature 40-45°C) was administered once daily at CV4, CV8, and bilateral SP6 for 20 minutes/session, from 7 days before menstruation through the last day of menstruation (approximately 7-10 sessions per cycle), across 3 active treatment cycles. Outcomes (VAS, RSS-COX, pain days, abdominal skin temperature) were assessed at baseline and after each of the three treatment cycles. Statistical analysis used Wilcoxon Signed-Rank tests for paired comparisons, Spearman correlation, and Kruskal-Wallis tests, with Bonferroni correction (SPSS v26).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged 18-35 years with a regular menstrual cycle (28 ± 7 days)
- •History of moderate-to-severe dysmenorrhea (VAS ≥ 4) in at least 3 consecutive menstrual cycles prior to enrolment
- •Willing to participate and providing written informed consent
排除标准
- •Secondary dysmenorrhea attributable to endometriosis, pelvic inflammatory disease, or uterine fibroids (confirmed by abdominal ultrasound)
- •Neurological disorders, immunodeficiency, or uncontrolled bleeding disorders
- •Any systemic medical condition contraindicating moxibustion
- •Use of prostaglandin synthesis inhibitors (PGSIs) within two weeks prior to enrolment
- •Pregnancy, lactation, or planned pregnancy within the following 6 months
- •Current use of NSAIDs or oral contraceptives
- •Ongoing or recent moxibustion treatment within 2 weeks prior to registration
研究组 & 干预措施
Moxibustion group
All 48 participants received suspended moxibustion at CV4, CV8, and bilateral SP6 for 20 minutes daily, from 7 days before menstruation through the end of the menstrual period, across three consecutive treatment cycles.
干预措施: Suspended moxibustion at CV4, CV8, SP6 (Other)
结局指标
主要结局
Change in Visual Analogue Scale (VAS) pain score
时间窗: Baseline and at the end of Cycle 1, Cycle 2, and Cycle 3 (each menstrual cycle is approximately 28 days)
The Cox Menstrual Symptom Scale (RSS-COX) is a validated self-report instrument measuring the frequency and severity of menstrual-related systemic symptoms, including back pain, fatigue, irritability, and headache. Higher scores indicate greater symptom burden.
次要结局
- Change in RSS-COX (Cox Menstrual Symptom Scale) symptom burden score(Baseline and at the end of Cycle 1, Cycle 2, and Cycle 3 (each menstrual cycle is approximately 28 days))
- Number of pain days per menstrual cycle(baseline and after each of three treatment cycles)
- Abdominal skin temperature (measured by FLIR C5 thermal imaging camera)(Immediately before (T0), immediately after (T1), and 15 minutes after (T2) each moxibustion session, assessed throughout Cycles 1 to 3)