Effects of Electroacupuncture at NP82 and SP15 on Bowel Motility in Healthy Subjects (EABM-HV)

University of Medicine and Pharmacy at Ho Chi Minh City

Status: Enrolling

Conditions: Healthy; Gastrointestinal Motility

Treatments: Procedure: Electroacupuncture at NP82 (Tongbian) and SP15 (Daheng)

Study type: Interventional

Funder types: Other

Identifiers

NCT07496697

473/HĐ-ĐHYD (Other Identifier)

Details and patient eligibility

About

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.

Full description

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:

1. Baseline Phase: Continuous 30-minute recording of bowel sounds to establish a physiological reference.
2. Intervention Phase: Simultaneous 20-minute recording during EA. Sterile needles (0.30×40mm) are inserted into NP82 and SP15 points until "De Qi" sensation is achieved. Stimulation utilizes a dense-disperse wave at a 10 Hz frequency, with intensity adjusted (0.1-1 mA) based on participant tolerance.
3. Post-intervention Phase: Continuous 30-minute recording after needle removal to evaluate sustained effects.

Data Analysis:

The primary quantitative variable is the Bowel Sound Interval (SSI), defined as the time between bowel sound events. Statistical analysis will be performed using Stata 17.0, employing Paired t-tests or Wilcoxon signed-rank tests to compare bowel sound frequencies across the three phases with a significance level of p < 0.05.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Electroacupuncture Group

Experimental group

Description:

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.

Treatment:

Procedure: Electroacupuncture at NP82 (Tongbian) and SP15 (Daheng)