Investigation of Bowel Motility Changes Following Electroacupuncture at NP82 (Tongbian) and SP15 (Daheng) Acupoint Pair in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Bowel Sound Interval (SSI)
研究概览
简要总结
This study aims to investigate how a specific combination of electroacupuncture points, Tongbian (NP82) and Daheng (SP15), affects bowel movements in healthy volunteers. Constipation is a significant health issue, especially for post-stroke patients, and current treatments like laxatives often have unwanted side effects. The researchers want to determine if stimulating these two acupuncture points can objectively increase the frequency of bowel activity.
Participants will undergo a three-stage procedure: a 30-minute period of baseline bowel sound recording, followed by 20 minutes of electroacupuncture stimulation at the specific points, and a final 30-minute recording period after the intervention. Throughout the study, an advanced digital stethoscope (3M™ Littmann® CORE) will be used to record bowel sounds objectively. This data will then be analyzed to measure any significant changes in bowel motility caused by the acupuncture.
详细描述
Background and Rationale:
Bowel motility is a fundamental physiological function regulated by the autonomic nervous system. This study explores the potential of electroacupuncture (EA) to modulate this activity using a unique acupoint combination: Dai Hoanh (SP15), a classic point known for regulating the Spleen and Stomach, and Thong Tien (NP82), a newly proposed "extra point" specifically indicated for treating paralysis-related constipation in traditional literature. The study aims to provide the first modern scientific evidence for the effectiveness of NP82 in stimulating bowel motility.
Methodology:
The study follows a before-and-after intervention design involving 30 healthy volunteers. To ensure objective measurement, bowel sounds are recorded using the 3M™ Littmann® CORE Digital Stethoscope, which amplifies sounds and allows for computerized analysis, overcoming the subjectivity of traditional auscultation.
The procedure consists of three phases:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers aged 18 years and older.
- •No symptoms related to constipation after comprehensive evaluation based on Rome IV criteria.
- •No gastrointestinal symptoms (abdominal pain, diarrhea, blood in stool, constipation, or bloating) in the 4 weeks prior to study participation.
- •No use of medications that promote or inhibit bowel motility in the 4 weeks prior to participation (including prokinetics, laxatives, antispasmodics, or opioids).
- •Fasting for at least 4 hours before the study session.
- •No mental or intellectual disorders; capable of understanding the acupuncture and assessment procedures.
- •Willingness to participate and signed informed consent form.
排除标准
- •Participants with severe medical conditions (heart, brain, liver, kidney, hematological system, infectious diseases, cancer, or psychiatric disorders).
- •Metabolic or functional disorders such as irritable bowel syndrome (IBS), thyroid dysfunction, or glucose/lipid metabolism disorders.
- •Use of bowel motility-altering medications within the 4 weeks prior to participation.
- •Participation in other clinical trials within the last 2 months.
- •Received acupuncture treatment within the last month.
- •Skin ulcers, abscesses, or infections at the acupuncture sites.
- •Known metal allergy or severe needle phobia.
研究组 & 干预措施
Electroacupuncture Group
This single group of 30 healthy volunteers will undergo a three-phase sequential protocol where each participant serves as their own control[cite: 139, 140, 161]. The procedure includes: (1) a 30-minute baseline bowel sound recording; (2) a 20-minute electroacupuncture session at acupoints NP82 and SP15 with simultaneous recording; and (3) a 30-minute post-intervention recording to evaluate sustained effects[cite: 171, 172, 179, 181, 182]. Bowel sounds are captured objectively using a 3M™ Littmann® CORE Digital Stethoscope.
干预措施: Electroacupuncture at NP82 (Tongbian) and SP15 (Daheng) (Procedure)
结局指标
主要结局
Bowel Sound Interval (SSI)
时间窗: Continuous recording across three phases: Baseline (30 minutes before intervention), During Intervention (20 minutes), and Post-intervention (30 minutes).
SSI is the time interval between the end of one bowel sound event and the start of the next. Bowel sounds are recorded and quantified using the 3M™ Littmann® CORE Digital Stethoscope and analyzed with Stata 17.0 software to determine changes in bowel motility.
次要结局
- Bowel Sound Duration Ratio (BSDR)(Continuous recording across three phases: Baseline (30 minutes), Active Electroacupuncture (20 minutes), and Post-intervention (30 minutes))
- Bowel Sound Frequency(Continuous recording across three phases: Baseline (30 minutes), Active Electroacupuncture (20 minutes), and Post-intervention (30 minutes))
- Minimum SSI Ratio (SSIR)(The total study duration is 80 minutes, consisting of: (1) Baseline phase: 30 minutes before intervention; (2) Intervention phase: 20 minutes during electroacupuncture; and (3) Post-intervention phase: 30 minutes after needle removal.)
研究者
Le Hoang Minh Quan
Lecturer at the University of Medicine and Pharmacy at Ho Chi Minh City
University of Medicine and Pharmacy at Ho Chi Minh City