An interventional study of Acupuncture in de qi of Acupuncture and Ultrasound Imaging, sponsored by China Medical University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-24.
Sponsored by China Medical University Hospital · Not applicable, Interventional, and Health services research
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.
China Medical University Hospital is the lead sponsor of 464 studies on the registry; 116 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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
Time frame: during each needling process of all acupuncture points over a course of 12 weeks
Plan to share: No
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China Medical University Hospital