Effect of Electroacupuncture at Neiguan on Cardiac and Gastric Function

Acupuncture have been used in clinical treatment of diseases for at least 3,000 years, and the efficacy of acupuncture has been recognized by countries all over the world. However, most of the selected points for acupuncture treatment of diseases are based on ancient books or inheritance of experience. For example, the " Shizong Acupoint Ballad " of acupuncture records: "Neiguan (PC6) care about the chest and stomach", that is, acupuncture Neiguan can be used to treat chest, heart and stomach diseases. However, there is no scientific evidence to verify this argument so far that the Shizong Acupoint Ballad mentions "Neiguan care for the chest and stomach", and that means that Neiguan acupoint can treat the diseases of cardiovascular system and gastrointestinal system. The purpose is to verify the argument of "Neiguan care about the chest and stomach", and design a clinical trial of the Neiguan and Jianshi (PC5) on both sides of the electroacupuncture (EA) to simultaneously evaluate the heart and stomach functions. We designed a crossover test; total 72 subjects randomly equally divide the into a sham group (sham electroacupuncture) and an EA group [2Hz EA (PC6 is cathode) and PC5 is anode]. At least one week of washing time, then the EA group changed to a sham group and the sham group changed to an EA group.

In this study, it is expected that the EA at PC6 and PC5 will affect the heart function and the function of the stomach at the same time, verifying the argument that "the PC6 care of the chest and stomach" recorded in the Shizong Acupoint Ballad.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiac and Gastric Function
• Intervention / Treatment: Other: electroacupuncture

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ching-Liang Hsieh; Phone Number: #3127 04-22053366; Email: clhsieh@mail.cmuh.org.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• (1) Normal and healthy participants
• (2) Male or female
• (3) The age range is 20 to 40 years old.
• (4) Those who participates and signs informed consent after explaining the research purpose and process in detail.

Exclusion Criteria:

• (1) Those with serious diseases, such as heart failure, chronic failure or cancer patients, etc.
• (2) Those who are allergic to stainless steel needles for acupuncture.
• (3) Pregnant or breastfeeding
• (4) Those who are taking medicines or food such as coffee, etc. that will affect heart function such as heart rate, or gastric peristalsis.
• (5) Unable to cooperate with researchers such as mental instability.
• (6) Those who do not sign the consent form.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A - electroacupuncture; electroacupuncture group Insert stainless steel acupuncture needles into Neiguan (cathode) and Jianshi (anode) on both sides and twist the needles. After that, the electroacupuncture machine was connected and 2 Hz electrical stimulation was administered for 30 minutes. The stimulation intensity was mainly based on slight muscle contractions and no pain in the subjects. At this time, cardiac function and electrogastrogram were recorded at the same time.	Other: electroacupuncture; Electroacupuncture at Neiguan and Jianshi acupoint; Other Names: acupuncture
Sham Comparator: Group B - Sham electroacupuncture; Sham electroacupuncture group The method was the same as that of the electroacupuncture group, but the needles were only acupuncture under the skin of Neiguan and Jianshi without twisting the needles. The electroacupuncture machine was connected but no electrical stimulation was administered.	Other: electroacupuncture; Electroacupuncture at Neiguan and Jianshi acupoint; Other Names: acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac Function	Evaluation of cardiac function with the "Osypka" non-invasive cardiac output monitor before electroacupuncture interventions . Cardiac function (OSCAR, non-invasive cardiac output meter) is first recorded for 30 minutes, and then intervention (electroacupuncture) is implemented, and cardiac function is recorded at the same time.	thirty minutes.
Cardiac Function	Evaluation of cardiac function with the "Osypka" non-invasive cardiac output monitor during electroacupuncture interventions. Cardiac function (OSCAR, non-invasive cardiac output meter) is first recorded for 30 minutes, and then intervention (electroacupuncture) is implemented, and cardiac function is recorded at the same time.	thirty minutes.
Cardiac Function	Evaluation of cardiac function with the "Osypka" non-invasive cardiac output monitor after electroacupuncture interventions. Cardiac function (OSCAR, non-invasive cardiac output meter) is first recorded for 30 minutes, and then intervention (electroacupuncture) is implemented, and cardiac function is recorded at the same time.	thirty minutes.
Cardiac Function	After at least one week (washing time), the two groups would be switched, and cardiac function is measured once in the same pattern. Evaluation of cardiac function with the "Osypka" non-invasive cardiac output monitor before sham electroacupuncture interventions. Cardiac function (OSCAR, non-invasive cardiac output meter) is first recorded for 30 minutes, and then intervention (sham electroacupuncture) is implemented, and cardiac function is recorded at the same time.	thirty minutes.
Cardiac Function	After at least one week (washing time), the two groups would be switched, and cardiac function is measured once in the same pattern. Evaluation of cardiac function with the "Osypka" non-invasive cardiac output monitor during sham electroacupuncture interventions. Cardiac function (OSCAR, non-invasive cardiac output meter) is first recorded for 30 minutes, and then intervention (sham electroacupuncture) is implemented, and cardiac function is recorded at the same time.	thirty minutes.
Cardiac Function	After at least one week (washing time), the two groups would be switched, and cardiac function is measured once in the same pattern. Evaluation of cardiac function with the "Osypka" non-invasive cardiac output monitor after sham electroacupuncture interventions. Cardiac function (OSCAR, non-invasive cardiac output meter) is first recorded for 30 minutes, and then intervention (sham electroacupuncture) is implemented, and cardiac function is recorded at the same time.	thirty minutes.
Gastric Function	Evaluation of gastric electrical rhythm with electrogastrography before electroacupuncture interventions. Gastric function (electrogastrography) is first recorded for 30 minutes, and then intervention (electroacupuncture) is implemented, and gastric function is recorded at the same time.	thirty minutes.
Gastric Function	Evaluation of gastric electrical rhythm with electrogastrography during electroacupuncture interventions. Gastric function (electrogastrography) is first recorded for 30 minutes, and then intervention (electroacupuncture) is implemented, and gastric function is recorded at the same time.	thirty minutes.
Gastric Function	Evaluation of gastric electrical rhythm with electrogastrography after electroacupuncture interventions. Gastric function (electrogastrography) is first recorded for 30 minutes, and then intervention (electroacupuncture) is implemented, and gastric function is recorded at the same time.	thirty minutes.
Gastric Function	After at least one week (washing time), the two groups would be switched, and cardiac function is measured once in the same pattern. Evaluation of gastric electrical rhythm with electrogastrography before electroacupuncture and sham electroacupuncture interventions. Gastric function (sham electroacupuncture) is first recorded for 30 minutes, and then intervention (sham electroacupuncture) is implemented, and gastric function is recorded at the same time.	thirty minutes.
Gastric Function	After at least one week (washing time), the two groups would be switched, and cardiac function is measured once in the same pattern. Evaluation of gastric electrical rhythm with electrogastrography during electroacupuncture and sham electroacupuncture interventions. Gastric function (sham electroacupuncture) is first recorded for 30 minutes, and then intervention (sham electroacupuncture) is implemented, and gastric function is recorded at the same time.	thirty minutes.
Gastric Function	After at least one week (washing time), the two groups would be switched, and cardiac function is measured once in the same pattern. Evaluation of gastric electrical rhythm with electrogastrography after electroacupuncture and sham electroacupuncture interventions. Gastric function (sham electroacupuncture) is first recorded for 30 minutes, and then intervention (sham electroacupuncture) is implemented, and gastric function is recorded at the same time.	thirty minutes.

Collaborators and Investigators

• Sponsor: China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): April 15, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: January 24, 2022
• First Submitted That Met QC Criteria: March 14, 2022
• First Posted (Actual): March 15, 2022

Study Record Updates

• Last Update Posted (Actual): March 15, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CMUH110-REC2-211

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual participant data (IPD) would be protected.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No