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

Official title

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

Overview

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.

Detailed 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.

Interventions

• Procedure Electroacupuncture at NP82 (Tongbian) and SP15 (Daheng)
  The intervention is performed by practitioners with at least 3 years of experience. Sterile acupuncture needles (0.30×40mm) are inserted vertically into the Tongbian (NP82 - located 3 cun lateral to the umbilicus) and Daheng (SP15 - located 4 cun lateral to the umbilicus) acupoints. Insertion depth ranges from 20 to 65 mm depending on the participant's body type, aiming to achieve the "De Qi" sensation (aching, heaviness, and tension). Electrical stimulation is applied using a Hwato SDZ-III devi

Primary outcome measures

• Bowel Sound Interval (SSI) [Time frame: Continuous recording across three phases: Baseline (30 minutes before intervention), During Intervention (20 minutes), and Post-intervention (30 minutes).]

Secondary outcome measures (1)

• Minimum SSI Ratio (SSIR) [Time frame: 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Basic science

Study locations

Vietnam · 1 center

• Faculty of Traditional Medicine, University of Medicine and Pharmacy at Ho Chi Minh City — Ho Chi Minh City

Publications

• Wang G, Wang M, Liu H, Zhao S, Liu L, Wang W. Changes in bowel sounds of inpatients undergoing general anesthesia. Biomed Eng Online. 2020 Jul 30;19(1):60. doi: 10.1186/s12938-020-00805-z. PMID 32731903
• Emoto T, Shono K, Abeyratne UR, Okahisa T, Yano H, Akutagawa M, Konaka S, Kinouchi Y. ARMA-based spectral bandwidth for evaluation of bowel motility by the analysis of bowel sounds. Physiol Meas. 2013 Aug;34(8):925-36. doi: 10.1088/0967-3334/34/8/925. Epub 2013 Jul 26. PMID 23893043
• Ong SS, Tang T, Xu L, Xu C, Li Q, Deng X, Shen P, Chen Y, Song Y, Lu H, Fang L. Research on the mechanism of core acupoints in electroacupuncture for functional constipation based on data mining and network acupuncture. Front Med (Lausanne). 2024 Dec 11;11:1482066. doi: 10.3389/fmed.2024.1482066. eCollection 2024. PMID 39722820
• Lê QNL, Tú Vân. Từ Điển Huyệt Vị Châm Cứu (Tái Bản). Nhà Xuất Bản Thuận Hóa; 2016.
• Abbasi P, Mojalli M, Kianmehr M, Zamani S. Effect of acupressure on constipation in patients undergoing hemodialysis: A randomized double-blind controlled clinical trial. Avicenna J Phytomed. 2019 Jan-Feb;9(1):84-91. PMID 30788281
• Zhao X, Liu L, Diao Y, Ma C. Effectiveness of abdominal electroacupuncture therapy for poststroke constipation: a meta-analysis. Front Neurol. 2024 Nov 22;15:1480681. doi: 10.3389/fneur.2024.1480681. eCollection 2024. PMID 39650243

Identifiers

NCT: NCT07496697 · 473/HĐ-ĐHYD · 473/HĐ-ĐHYD

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗