Effects of Electroacupuncture at NP82 and SP15 on Bowel Motility in Healthy Subjects

Investigation of Bowel Motility Changes Following Electroacupuncture at NP82 (Tongbian) and SP15 (Daheng) Acupoint Pair in Healthy Volunteers

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.

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.

Blinded Outcome Assessment Note:

Although the clinical phase of this trial is formally registered as open-label (None/Open) due to its single-arm pre-post interventional design, a rigorous blinded outcome assessment was implemented during data analysis. The raw digital acoustic recordings were completely de-identified, randomized, and assigned arbitrary codes. The independent clinical experts responsible for manual bowel sound annotation and validation were fully masked to the participants' identities and the chronological sequence of the recording phases (baseline, active electroacupuncture, or post-intervention).

Data Analysis:

Automated signal preprocessing, ARMA-based event segmentation, and acoustic parameter extraction will be executed using Python programming software (version 3.10 or later) utilizing the SciPy and NumPy packages. All subsequent statistical analyses will be performed using R statistical software (version 4.3.0 or later; R Core Team, Vienna, Austria). Since acoustic bowel motility parameters do not exhibit a normal distribution (evaluated via the Shapiro-Wilk test), non-parametric paired Wilcoxon signed-rank tests will be utilized for all pairwise comparisons across the three experimental phases (baseline vs. active intervention, baseline vs. post-intervention, and active intervention vs. post-intervention). Continuous variables will be reported as Medians with Interquartile Ranges (IQR). A p-value of < 0.05 will establish the threshold for statistical significance for all tests

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.