de qi of AcupunctureNCT05872906
Using Ultrasound and Acupuncture to Explore the De-qi Location and Reaction of Specific Acupoints
A study testing Acupuncture in people with de qi of Acupuncture and Ultrasound Imaging, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
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". Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- de qi of Acupuncture, Ultrasound Imaging
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Mar 2023to 5 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age ≥ 20 years and healthy subjects
Who cannot join
- pregnancy
- patients with chronic diseases such as hypertension, diabetes mellitus, chronic hepatitis, chronic kidney disease
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung, 40447
Hsien-Yin Liao, PhD, +886-4-2205-2121, jamesliao1076@hotmail.com
About this study
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.
- Conditions
- de qi of Acupuncture, Ultrasound Imaging
- Being tested
- Acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | 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. Receives: Device: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: during each needling process of all acupuncture points over a course of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start6 Mar 2023
- Primary completion5 Mar 2024 (estimated)
- Study completion5 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for de qi of AcupunctureStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872906
- Sponsor's protocol ID
- CMUH112-REC2-016
- Status last verified
- May 2023
- First submitted
- 21 Apr 2023
- Last updated
- 24 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Ultrasound and Acupuncture to Explore the De-qi Location and Reaction of Specific Acupoints
- ClinicalTrials.gov ID
- NCT05872906
- Acronym / sponsor ID
- CMUH112-REC2-016
- Conditions
- de qi of Acupuncture, Ultrasound Imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 5 Mar 2024 (estimated)
- Study completion
- 5 Mar 2024 (estimated)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Device: AcupunctureAll 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age ≥ 20 years and healthy subjects
Key exclusion criteria (2 listed)
- pregnancy
- patients with chronic diseases such as hypertension, diabetes mellitus, chronic hepatitis, chronic kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureA 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. | Device | Acupuncture |
Primary outcome
B-mode ultrasound image of the acupuncture site using a linear probe
Time frame: during each needling process of all acupuncture points over a course of 12 weeks
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.
Subject sensation questionnaire modified from the Massachusetts General Hospital Acupuncture Sensation Scale (MASS)
Time frame: during each needling process of all acupuncture points over a course of 12 weeks
Needling sensations will be collected throughout the needling process.
Subject sensation questionnaire modified from the Southampton Needle Sensation Questionnaire (SNSQ)
Time frame: during each needling process of all acupuncture points over a course of 12 weeks
Needling sensations will be collected throughout the needling process.
Pulse wave data taken with ANSWatch
Time frame: immediately prior to (within 5 minutes) and after (within 5 minutes) needling of each acupuncture point over a course of 12 weeks
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).
External video footage of visually observable events (such as muscle contraction) associated with de qi event
Time frame: during each needling process of all acupuncture points over a course of 12 weeks
An external video footage will be recorded of the acupuncture site during the needling process
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with de qi of Acupuncture and Ultrasound Imaging, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hsien-Yin Liao, PhD (+886-4-2205-2121, jamesliao1076@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
B-mode ultrasound image of the acupuncture site using a linear probe (time frame: during each needling process of all acupuncture points over a course of 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023; AzTrials last refreshed its copy on 6 Nov 2026.