Healthy VolunteersNCT05578040
Skin Surface's Temperature Changes When Auricular Acupressure at Cervical Vertebra Acupoints in Healthy Volunteers
A study testing Auricular acupressure in people with Healthy Volunteers, run by Bui Pham Minh Man at 1 site in Vietnam.
Trial summary
Auricular acupressure is one of the acupuncture techniques on the ear, which is a method of impacting on acupoints with force and without using needles to help diagnose and treat physical and psychosomatic dysfunctions. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Auricular acupressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Oct 2022to 30 Jun 2023
- 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 volunteers, regardless of gender or profession
- Age between enough 18 and 30 years old.
- No psychological problems (anxiety, depression, stress): assessed according to DASS 21 score, with stress score < 15 points.
- Vital signs within normal limits:
- Heart rates from 60 to 100 beats/minute
- Systolic blood pressure between 90 and 139 mmHg
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- Diastolic blood pressure between 60 and 89 mmHg
- Body temperature: 36.59 ± 0.43 0C
- Breathing rate: 16 ± 3 times/minute
- Voluntarily agree to participate in the research and sign the consent form to participate in the research after being advised by the researcher and clearly explaining the rights and obligations when participating in the research.
- Not currently participating in other intervention studies.
- No knowledge and experience of auricular acupressure method.
Who cannot join
- Having an inflammatory injury in the site of the skin to be investigated.
- Using heat therapy, for example, massage, cupping therapy, and acupuncture in the site of the skin to be investigated within 24h.
- Applying chemical or pharmaceutical products to the site of the skin to be surveyed before conducting the study.
- Other diseases that could affect or interfere with outcomes, including the common cold or flu.
- Having neck pain, dermatitis, skin infection, and wound in the survey area.
- Having diseases that change the body temperature, like hyperthyroidism, and hypothyroidism.
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- Taking stimulants (alcohol, beer, coffee, tobacco) within 24h.
- Staying up at night or having insomnia before the day of the study.
- Playing sport within 2h.
- Pregnant woman or woman in the period.
- Are taking some sleeping pills, sedatives, or drugs that cause vasodilation, lower blood pressure
- Anxiety, depression, and stress before conducting the study with DASS 21 score > 15 points.
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 the Changing Temperature of the Skin Surface in the Neck Area When Auricular Acupressure at Cervical Vertebra Acupoints in Healthy Volunteers: a Randomized Controlled Trial
Auricular acupressure is one of the acupuncture techniques on the ear, which is a method of impacting on acupoints with force and without using needles to help diagnose and treat physical and psychosomatic dysfunctions. Some studies prove that the acupoints on the pinna have a corresponding relationship with the areas of the body, and when acting on the acupoints can change the temperature of the corresponding area. Chronic neck pain is closely related to the decline in subcutaneous microcirculation, where heat transfer from deep within the body to the surface of the skin is carried out by the dermal vascular system. When blood flow through the venous network is high, heat is carried from the deep to the skin and vice versa. Therefore, to understand the role of cervical vertebra acupoints in neck pain, the study wants to demonstrate the correlation when auricular acupressure at cervical vertebra acupoints and the skin surface temperature of the neck area.
Read the detailed description
Participants and Methods: A randomized controlled trial is conducted by surveying the change in temperature in the neck area respectively when auricular acupressure is applied to the left and right cervical vertebra acupoints compared with the sham auricular acupressure group in each side of the ear in healthy volunteers. A total of 60 participants were randomly assigned to 2 groups (A and B) and the allocation was 1:1. In group A: participants received sham auricular acupressure at the left AH13 acupoint (left cervical vertebra) of the ear and auricular acupressure after 1 week. In group B: participants received sham auricular acupressure at the right AH13 acupoint (right cervical vertebra) of the ear and auricular acupressure after 1 week. The primary outcome was change in temperature in the neck area respectively when auricular acupressure is applied to the left and right cervical vertebra acupoints compared with the sham auricular acupressure group. This trial will be performed as randomized, controlled, and single blinded.
- Conditions
- Healthy Volunteers
- Being tested
- Auricular acupressure
- Keywords
- Auricular Acupressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular acupressureProcedure or surgery
To conduct this intervention, we used adhesive patches without Vaccaria seed to sham auricular acupressure at the cervical vertebra acupoint in the first trial phase and auricular acupressure at the cervical vertebra acupoint in the other two trial phases in 2 groups of auricular acupressure acupoints of the left and right cervical vertebra.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Left AH13 acupoint (left cervical vertebra) | Experimental | Participants received sham auricular acupressure by adhesive patches without Vaccaria seed at the left auricular cervical vertebra acupoint and auricular acupressure Vaccaria seed at the left auricular cervical vertebra acupoint after 1 week. At each time, the skin surface temperature of the neck area will be recorded. Receives: Procedure: Auricular acupressure |
| Group B: RIght AH13 acupoint (right cervical vertebra) | Experimental | Participants received sham auricular acupressure by adhesive patches without Vaccaria seed at the right auricular cervical vertebra acupoint - and auricular acupressure Vaccaria seed at the right auricular cervical vertebra acupoint after 1 week. At each time, the skin surface temperature in the neck area will be recorded. Receives: Procedure: Auricular acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survey the change in temperature in the neck area respectively when auricular acupressure is applied to the left and right cervical vertebra acupoints compared with the sham auricular acupressure group
Measured: During procedure
Change the temperature of skin surface in the neck area when using auricular acupressure at cervical vertebra acupoints on 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 posted13 Oct 2022
- Study start1 Oct 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- A randomized controlled and single blinded trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bui Pham Minh Man
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bui Pham Minh Man, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05578040
- Sponsor's protocol ID
- 676/HDDD-DHYD
- Status last verified
- Oct 2023
- First submitted
- 10 Oct 2022
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Demographic characteristic and outcome data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey on the Changing Temperature of the Skin Surface in the Neck Area When Auricular Acupressure at Cervical Vertebra Acupoints in Healthy Volunteers: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05578040
- Acronym / sponsor ID
- 676/HDDD-DHYD
- Conditions
- Healthy Volunteers
- Keywords
- Auricular Acupressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bui Pham Minh ManUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 13 Oct 2022 (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 acupressure is one of the acupuncture techniques on the ear, which is a method of impacting on acupoints with force and without using needles to help diagnose and treat physical and psychosomatic dysfunctions. Some studies prove that the acupoints on the pinna have a corresponding relationship with the areas of the body, and when acting on the acupoints can change the temperature of the corresponding area. Chronic neck pain is closely related to the decline in subcutaneous microcirculation, where heat transfer from deep within the body to the surface of the skin is carried out by the dermal vascular system. When blood flow through the venous network is high, heat is carried from the deep to the skin and vice versa. Therefore, to understand the role of cervical vertebra acupoints in neck pain, the study wants to demonstrate the correlation when auricular acupressure at cervical vertebra acupoints and the skin surface temperature of the neck area.
Detailed description
Participants and Methods: A randomized controlled trial is conducted by surveying the change in temperature in the neck area respectively when auricular acupressure is applied to the left and right cervical vertebra acupoints compared with the sham auricular acupressure group in each side of the ear in healthy volunteers. A total of 60 participants were randomly assigned to 2 groups (A and B) and the allocation was 1:1. In group A: participants received sham auricular acupressure at the left AH13 acupoint (left cervical vertebra) of the ear and auricular acupressure after 1 week. In group B: participants received sham auricular acupressure at the right AH13 acupoint (right cervical vertebra) of the ear and auricular acupressure after 1 week. The primary outcome was change in temperature in the neck area respectively when auricular acupressure is applied to the left and right cervical vertebra acupoints compared with the sham auricular acupressure group. This trial will be performed as randomized, controlled, and single blinded.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A randomized controlled and single blinded trial
| Arm | Type | Receives |
|---|---|---|
| Group A: Left AH13 acupoint (left cervical vertebra) | Experimental | Procedure: Auricular acupressureParticipants received sham auricular acupressure by adhesive patches without Vaccaria seed at the left auricular cervical vertebra acupoint and auricular acupressure Vaccaria seed at the left auricular cervical vertebra acupoint after 1 week. At each time, the skin surface temperature of the neck area will be recorded. |
| Group B: RIght AH13 acupoint (right cervical vertebra) | Experimental | Procedure: Auricular acupressureParticipants received sham auricular acupressure by adhesive patches without Vaccaria seed at the right auricular cervical vertebra acupoint - and auricular acupressure Vaccaria seed at the right auricular cervical vertebra acupoint after 1 week. At each time, the skin surface temperature in the neck area will be recorded. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Healthy volunteers, regardless of gender or profession
- Age between enough 18 and 30 years old.
- No psychological problems (anxiety, depression, stress): assessed according to DASS 21 score, with stress score < 15 points.
- Vital signs within normal limits:
- Voluntarily agree to participate in the research and sign the consent form to participate in the research after being advised by the researcher and clearly explaining the rights and obligations when participating in the research.
Key exclusion criteria (12 listed)
- Having an inflammatory injury in the site of the skin to be investigated.
- Using heat therapy, for example, massage, cupping therapy, and acupuncture in the site of the skin to be investigated within 24h.
- Applying chemical or pharmaceutical products to the site of the skin to be surveyed before conducting the study.
- Other diseases that could affect or interfere with outcomes, including the common cold or flu.
- Having neck pain, dermatitis, skin infection, and wound in the survey area.
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 acupressureTo conduct this intervention, we used adhesive patches without Vaccaria seed to sham auricular acupressure at the cervical vertebra acupoint in the first trial phase and auricular acupressure at the cervical vertebra acupoint in the other two trial phases in 2 groups of auricular acupressure acupoints of the left and right cervical vertebra. | Procedure or surgery | Group A: Left AH13 acupoint (left cervical vertebra), Group B: RIght AH13 acupoint (right cervical vertebra) |
Primary outcome
Survey the change in temperature in the neck area respectively when auricular acupressure is applied to the left and right cervical vertebra acupoints compared with the sham auricular acupressure group
Time frame: During procedure
Change the temperature of skin surface in the neck area when using auricular acupressure at cervical vertebra acupoints on 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 23 Oct 2023.
- Guan L, Li G, Yang Y, Deng X, Cai PJNRR. 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?. 2012;7(9):680.Link provided by the sponsor.
- Song X, Zhang DJZZjCA, Moxibustion. Study on the manifestation of facial infrared thermography induced by acupuncturing Guangming (GB 37) and Hegu (LI 4). 2010;30(1):51-54Link provided by the sponsor.
- 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 acupressure in people with Healthy Volunteers, run by Bui Pham Minh Man 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 12 inclusion and 12 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 23 Oct 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 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?
Survey the change in temperature in the neck area respectively when auricular acupressure is applied to the left and right cervical vertebra acupoints compared with the sham auricular acupressure group (time frame: During procedure). The study lists 2 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 23 Oct 2023.