Using Ultrasound and Acupuncture to Explore the De-qi Location and Reaction of Specific Acupoints

According to ancient literature, when de qi occurs in the process of acupuncture, the patient may experience sensations such as soreness, numbness, heaviness, swelling. Meanwhile, the acupuncturist may experience the sensation of "a fish taking a bite from the bait on a hook". However, for a beginner at acupuncture, before they have learned to trigger the de qi sensation, it is hard for them to learn according to the ambiguous definition of "a fish taking a bite from the bait on a hook" and thus hard to know whether they have reached the correct location and stimulated de-qi. In this study, through multiple experienced acupuncturists acupuncture multiple test subjects, the investigators will locate the location and the reaction of de qi on the acupoint Quchi (LI11) with ultrasound observation and recording. Through the ultrasound teaching and guidance, the investigators will test whether it is possible to reversely use ultrasound imaging to guide less experienced acupuncturists to the de qi location and elicit de qi response on multiple test subjects. Therefore, the investigators propose this study to test the following hypothesis:"There is a specific anatomical site where de qi occurs at LI11, and it is possible to use ultrasound imaging to guide learners to reach that location and trigger de-qi and that it is applicable to other acupoints". To explore the above hypothesis, the investigators will target the following specific aims. Aim 1: Use ultrasound record and indicate the precise anatomical location and reaction when de qi occurs on acupoint LI11. Aim 2: Simultaneously record the physicians' needling sensations, the participants' needling sensations, twitch response of the participant under ultrasound images. Aim 3: Prove the feasibility of using ultrasound to guide inexperienced physicians to reach the correct location and elicit de qi sensation on the participants. Aim 4: Discuss the relationship between de qi and pulse diagnosis. Aim 5: Apply the above procedures to other acupuncture points such as LU5(Chize), PC3 (Quze),…etc.

Study Overview

• Status: Recruiting
• Conditions: Ultrasound Imaging; de qi of Acupuncture
• Intervention / Treatment: Device: Acupuncture

• Study Type: Interventional
• Enrollment (Anticipated): 6
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hsien-Yin Liao, PhD; Phone Number: +886-4-2205-2121; Email: jamesliao1076@hotmail.com

Study Locations

• Taiwan
  • Taichung, Taiwan, 40447
    • Recruiting
    • China Medical University Hospital
    • Contact: Hsien-Yin Liao, PhD; Phone Number: +886-4-2205-2121; Email: jamesliao1076@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• age ≥ 20 years and healthy subjects

Exclusion Criteria:

• pregnancy
• patients with chronic diseases such as hypertension, diabetes mellitus, chronic hepatitis, chronic kidney disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture; All subjects will receive acupuncture at LI11, ST36, SP10, SP9, SP6, ST34, BL39, KI10, LIV8, LI10, HT3, SI8, LI4, PC6, HT7, GB34, GB40, KI3, BL2, GB20, LIV3, BL62, KI6, BI57, ST40, KI7 and be recorded with simultaneous ultrasound imaging, external video, and required to fill out sensation sheets. Pulse diagnosis will be taken after de qi is achieved.	Device: Acupuncture; A 1.5-inch needle of 34 gauge (CASOON stainless steel acupuncture needles) is inserted. The physician will then locate the de qi location of the test subjects and elicit a de qi response accompanied by muscle twitch.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
B-mode ultrasound image of the acupuncture site using a linear probe	B-mode ultrasound image of the acupuncture site using a linear probe will be recorded throughout the needling process. The video would enable the investigators to identify the underlying anatomical structures of the acupuncture point and locate the location of the needle tip where de qi occurs.	during each needling process of all acupuncture points over a course of 12 weeks
Subject sensation questionnaire modified from the Massachusetts General Hospital Acupuncture Sensation Scale (MASS)	Needling sensations will be collected throughout the needling process.	during each needling process of all acupuncture points over a course of 12 weeks
Subject sensation questionnaire modified from the Southampton Needle Sensation Questionnaire (SNSQ)	Needling sensations will be collected throughout the needling process.	during each needling process of all acupuncture points over a course of 12 weeks
Pulse wave data taken with ANSWatch	Pulse wave data will be taken with ANSWatch. Data for each test subject will be collected prior to and after the needling process (de qi is achieved).	immediately prior to (within 5 minutes) and after (within 5 minutes) needling of each acupuncture point over a course of 12 weeks
External video footage of visually observable events (such as muscle contraction) associated with de qi event	An external video footage will be recorded of the acupuncture site during the needling process	during each needling process of all acupuncture points over a course of 12 weeks

Collaborators and Investigators

• Sponsor: China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2023
• Primary Completion (Anticipated): March 5, 2024
• Study Completion (Anticipated): March 5, 2024

Study Registration Dates

• First Submitted: April 21, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Actual): May 24, 2023

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CMUH112-REC2-016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No