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| ID | Type | Description | Link |
|---|---|---|---|
| 473/HĐ-ĐHYD | Other Identifier | University of Medicine and Pharmacy at Ho Chi Minh City |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electroacupuncture Group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroacupuncture at NP82 (Tongbian) and SP15 (Daheng) | Procedure | 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 device with a dense-disperse wave at a frequency of 10 Hz for 20 minutes. The current intensity is adjusted (0.1-1 mA) until a mild muscle vibration is visible without causing pain to the participant. |
| Measure | Description | Time Frame |
|---|---|---|
| Bowel Sound Interval (SSI) | 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. | Continuous recording across three phases: Baseline (30 minutes before intervention), During Intervention (20 minutes), and Post-intervention (30 minutes). |
| Measure | Description | Time Frame |
|---|---|---|
| Minimum SSI Ratio (SSIR) | SSIR is calculated as the ratio of the minimum Bowel Sound Interval (SSI) during or after the intervention (Ba) to the minimum SSI before the intervention (Bb). SSI values are derived from digital recordings of bowel sounds captured by a 3M™ Littmann® CORE Digital Stethoscope. The analysis focuses on 10-minute windows within each phase to determine the maximum increase in bowel motility compared to the baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Minh Quan Le Hoang, MSc, MD | Contact | +84792112077 | lhminhquan@ump.edu.vn |
| Name | Affiliation | Role |
|---|---|---|
| Minh Quan Le Hoang, MSc, MD | University of Medicine and Pharmacy at Ho Chi Minh City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Traditional Medicine, University of Medicine and Pharmacy at Ho Chi Minh City | Recruiting | Ho Chi Minh City | Ho Chi Minh | 72200 | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32731903 | Result | 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. | |
| 23893043 | Result | 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. |
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There is currently no plan to share individual participant data (IPD) to ensure the confidentiality of participants. However, the study results and findings will be disseminated in aggregate form through publications in peer-reviewed journals.
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This is a single-arm, pre-post interventional study where each participant serves as their own control. The protocol consists of three consecutive phases: (1) a 30-minute baseline bowel sound recording phase, (2) a 20-minute recording phase during electroacupuncture stimulation at acupoints NP82 and SP15, and (3) a 30-minute post-intervention recording phase[cite: 171, 181, 182]. Bowel motility changes are assessed by comparing quantitative acoustic data captured during these three sequential stages.
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| 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. |
| 39722820 | Result | 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. |
| Result | Lê QNL, Tú Vân. Từ Điển Huyệt Vị Châm Cứu (Tái Bản). Nhà Xuất Bản Thuận Hóa; 2016. |
| 30788281 | Result | 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. |
| 39650243 | Result | 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. |