Effects of Electroacupuncture at NP82 and SP15 on Bowel Motility in Healthy Subjects
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-30
SponsorUniversity of Medicine and Pharmacy at Ho Chi Minh City
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Electroacupuncture at NP82 (Tongbian) and SP15 (Daheng)
Procedure/SurgeryThe 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Electroacupuncture GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Continuous recording across three phases: Baseline (30 minutes before intervention), During Intervention (20 minutes), and Post-intervention (30 minutes).Secondary outcomes
1
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.
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.Sponsors and contacts
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Source ClinicalTrials.gov