HealthyNCT05164302
Skin Surface's Temperature Change When Auricular Acupuncture at Jaw Point and Tooth Point
A study testing Auricular acupuncture in people with Healthy, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
Auricular acupuncture is a method for diagnosing and treating physical and psychosomatic dysfunctions by stimulating a specific point in the ear. Some studies prove that the acupoints on the pinna have a corresponding relationship to the areas of the body. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Auricular acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Jan 2022to 31 May 2022
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteer with normal vital signs
- Volunteers who agree to participate and sign the Informed Consent Form, following a detailed explanation of clinical trials
- DASS 21 score within normal limits
- BMI: 18.5 - 23 kg/m2
Who cannot join
- Inappropriate condition for auricular acupuncture due to skin disease (the skin of the acupuncture point is swollen, hot and red)
- Pregnant woman or breastfeeding woman or woman in period
- Other diseases that could affect or interfere with outcomes, including cardiovascular disease, thyroid disorder, facial disease.
- Taking vasodilators or sunscreen in the examined skin areas
- Taking stimulant (alcohol, beer, coffee, tobacco) within 24h
- Massage or cupping therapy or acupuncture in facial area within 24h
- Playing sport within 2h
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Faculty of Traditional medicine - University of Medicine and Pharmacy of Ho Chi Minh City
Ho Chi Minh City
About this study
Official title: Survey on Skin Surface's Temperature Change When Auricular Acupuncture at Jaw Point (LO1) and Tooth Point (LO3) on Heatlhy Volunteer: a Pilot Study
Auricular acupuncture is a method for diagnosing and treating physical and psychosomatic dysfunctions by stimulating a specific point in the ear. Some studies prove that the acupoints on the pinna have a corresponding relationship to the areas of the body. Some research also show that acupuncture acupoints on the body can change the temperature of the corresponding area. In our study, we survey the skin surface's temperature change when using auricular acupuncture at jaw point and tooth point in each side of the ear in heatlhy people.
Read the detailed description
Participants and Methods: A crossover study is conducted by comparing the in skin surface's temperature change before and after applying auricular acupuncture at Jaw point (LO1) and Tooth point (LO3) in each side of the ear in heatlhy volunteer. A total of 70 participants were randomly assigned to 2 group (A and B) and the allocation was 1:1. In group A: participants received auricular acupuncture at tooth point (LO1) three times: Left ear, Right ear and Sham accupunture. Similarly, LO1 point was replaced by LO3 point (Jaw point) for participants in group B. The primary outcome was change temperature of skin surface at the pinna and lower jaw when using auricular acupuncture at points: LO1 and LO3 in each side of the ear. This trial will be performed as 2-arm crossover design, randomized, controlled.
- Conditions
- Healthy
- Being tested
- Auricular acupuncture
- Keywords
- Auricular Acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular acupunctureProcedure or surgery
Auricular acupuncture is a method for diagnosing and treating physical and psychosomatic dysfunctions by stimulating a specific point in the ear. To conducting this intervention, we use press tack needles to perform auricular acupuncture.
| Study group | Role | What they receive |
|---|---|---|
| Group A: LO1 point (Tooth) | Experimental | Participant received auricular acupuncture and sham acupuncture at LO1 point in each side of the ear. In each session, temperature of skin surface at the pinna and lower jaw will be recorded. Receives: Procedure: Auricular acupuncture |
| Group B: LO3 point (Jaw) | Experimental | Participant received auricular acupuncture and sham acupuncture at LO3 point in each side of the ear. In each session, temperature of skin surface at the pinna and lower jaw will be recorded. Receives: Procedure: Auricular acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change temperature of skin surface at the pinna and lower jaw when using auricular acupuncture at tooth point in each side of the ear
Measured: During procedure
Secondary outcomes (1)
Change temperature of skin surface at the pinna and lower jaw when using auricular acupuncture at jaw point in each side of the ear
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start1 Jan 2022
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 2-arm crossover design, a pilot study
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bui Pham Minh Man, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05164302
- Sponsor's protocol ID
- IRB-VN01002
- Status last verified
- Nov 2022
- First submitted
- 26 Nov 2021
- Last updated
- 28 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Demographic characteristic and outcome data will be shared
Publications
Hou PW, Hsu HC, Lin YW, Tang NY, Cheng CY, Hsieh CL. The History, Mechanism, and Clinical Application of Auricular Therapy in Traditional Chinese Medicine. Evid Based Complement Alternat Med. 2015;2015:495684. doi: 10.1155/2015/495684. Epub 2015 Dec 28.
PubMed 26823672Tsuruoka N, Katayama S, Seki T, Matsunaga T, Iijima R, Haga Y. Focused Ultrasound PC-6 Stimulation Effects on Blood Flow Volume, Skin Temperature, and Coldness of the Finger and Toe. Complement Med Res. 2019;26(6):404-409. doi: 10.1159/000501149. Epub 2019 Jul 5.
PubMed 31280256Wang D, Ji B, Yan M, Bai H, Sun X, Dai J, Lu Y, Liu Y, You M, Wu J, Ge Y, Su H, Cheng K, Zhao G. Effect of electroacpuncture of Neiguan (PC 6) and Tianquan (PC 2) on skin temperature, blood perfusion, and adrenoceptor response in rats with acute myocardial ischemia. J Tradit Chin Med. 2017 Dec;37(6):794-803.
PubMed 32188189Guan L, Li G, Yang Y, Deng X, Cai P. Infrared thermography and meridian-effect evidence and explanation in Bell's palsy patients treated by moxibustion at the Hegu (LI4) acupoint: Overall regulation or a specific target? Neural Regen Res. 2012 Mar 25;7(9):680-5. doi: 10.3969/j.issn.1673-5374.2012.09.007.
PubMed 25745463
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey on Skin Surface's Temperature Change When Auricular Acupuncture at Jaw Point (LO1) and Tooth Point (LO3) on Heatlhy Volunteer: a Pilot Study
- ClinicalTrials.gov ID
- NCT05164302
- Acronym / sponsor ID
- IRB-VN01002
- Conditions
- Healthy
- Keywords
- Auricular Acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 20 Dec 2021 (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.
Auricular acupuncture is a method for diagnosing and treating physical and psychosomatic dysfunctions by stimulating a specific point in the ear. Some studies prove that the acupoints on the pinna have a corresponding relationship to the areas of the body. Some research also show that acupuncture acupoints on the body can change the temperature of the corresponding area. In our study, we survey the skin surface's temperature change when using auricular acupuncture at jaw point and tooth point in each side of the ear in heatlhy people.
Detailed description
Participants and Methods: A crossover study is conducted by comparing the in skin surface's temperature change before and after applying auricular acupuncture at Jaw point (LO1) and Tooth point (LO3) in each side of the ear in heatlhy volunteer. A total of 70 participants were randomly assigned to 2 group (A and B) and the allocation was 1:1. In group A: participants received auricular acupuncture at tooth point (LO1) three times: Left ear, Right ear and Sham accupunture. Similarly, LO1 point was replaced by LO3 point (Jaw point) for participants in group B. The primary outcome was change temperature of skin surface at the pinna and lower jaw when using auricular acupuncture at points: LO1 and LO3 in each side of the ear. This trial will be performed as 2-arm crossover design, randomized, controlled.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2-arm crossover design, a pilot study
| Arm | Type | Receives |
|---|---|---|
| Group A: LO1 point (Tooth) | Experimental | Procedure: Auricular acupunctureParticipant received auricular acupuncture and sham acupuncture at LO1 point in each side of the ear. In each session, temperature of skin surface at the pinna and lower jaw will be recorded. |
| Group B: LO3 point (Jaw) | Experimental | Procedure: Auricular acupunctureParticipant received auricular acupuncture and sham acupuncture at LO3 point in each side of the ear. In each session, temperature of skin surface at the pinna and lower jaw will be recorded. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy volunteer with normal vital signs
- Volunteers who agree to participate and sign the Informed Consent Form, following a detailed explanation of clinical trials
- DASS 21 score within normal limits
- BMI: 18.5 - 23 kg/m2
Key exclusion criteria (7 listed)
- Inappropriate condition for auricular acupuncture due to skin disease (the skin of the acupuncture point is swollen, hot and red)
- Pregnant woman or breastfeeding woman or woman in period
- Other diseases that could affect or interfere with outcomes, including cardiovascular disease, thyroid disorder, facial disease.
- Taking vasodilators or sunscreen in the examined skin areas
- Taking stimulant (alcohol, beer, coffee, tobacco) within 24h
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 |
|---|---|---|
| Auricular acupunctureAuricular acupuncture is a method for diagnosing and treating physical and psychosomatic dysfunctions by stimulating a specific point in the ear. To conducting this intervention, we use press tack needles to perform auricular acupuncture. | Procedure or surgery | Group A: LO1 point (Tooth), Group B: LO3 point (Jaw) |
Primary outcome
Change temperature of skin surface at the pinna and lower jaw when using auricular acupuncture at tooth point in each side of the ear
Time frame: During procedure
1 secondary outcome
Change temperature of skin surface at the pinna and lower jaw when using auricular acupuncture at jaw point in each side of the ear
Time frame: During procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2022.
- Background: PubMed 26823672Hou PW, Hsu HC, Lin YW, Tang NY, Cheng CY, Hsieh CL. The History, Mechanism, and Clinical Application of Auricular Therapy in Traditional Chinese Medicine. Evid Based Complement Alternat Med. 2015;2015:495684. doi: 10.1155/2015/495684. Epub 2015 Dec 28.
- Background: PubMed 31280256Tsuruoka N, Katayama S, Seki T, Matsunaga T, Iijima R, Haga Y. Focused Ultrasound PC-6 Stimulation Effects on Blood Flow Volume, Skin Temperature, and Coldness of the Finger and Toe. Complement Med Res. 2019;26(6):404-409. doi: 10.1159/000501149. Epub 2019 Jul 5.
- Background: PubMed 32188189Wang D, Ji B, Yan M, Bai H, Sun X, Dai J, Lu Y, Liu Y, You M, Wu J, Ge Y, Su H, Cheng K, Zhao G. Effect of electroacpuncture of Neiguan (PC 6) and Tianquan (PC 2) on skin temperature, blood perfusion, and adrenoceptor response in rats with acute myocardial ischemia. J Tradit Chin Med. 2017 Dec;37(6):794-803.
- Background: PubMed 25745463Guan L, Li G, Yang Y, Deng X, Cai P. Infrared thermography and meridian-effect evidence and explanation in Bell's palsy patients treated by moxibustion at the Hegu (LI4) acupoint: Overall regulation or a specific target? Neural Regen Res. 2012 Mar 25;7(9):680-5. doi: 10.3969/j.issn.1673-5374.2012.09.007.
- Individual participant dataSharing planned: Yes. Demographic characteristic and outcome data will be shared
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular acupuncture in people with Healthy, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 28 Nov 2022. 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 Vietnam. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change temperature of skin surface at the pinna and lower jaw when using auricular acupuncture at tooth point in each side of the ear (time frame: During procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05164302, which also lists 4 linked publications.
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 28 Nov 2022.