Temperature Change, BodyNCT06169098
Changes in Lumbar Region Temperature During Auricular Acupressure at Kidney Point
A study testing Auricular acupressure on the left ear and Auricular acupressure on the right ear in people with Temperature Change, Body, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
In Traditional Medicine, auricular acupressure (AA) is one of the non-pharmacological treatment methods commonly utilized due to its safety and convenience. AA involves the application of a taped seed of Vaccaria (with a diameter of 2mm) on specific ear acupoints to manage various disorders. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Temperature Change, Body
- What is being tested?
- Auricular acupressure on the left ear and Auricular acupressure on the right ear
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteVietnam
- Study dates
- 14 Dec 2023to 28 Apr 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 18.5 and 23 kg/m2.
- Demonstrates alertness and cooperativeness.
- Vital signs within normal limits.
- Voluntary informed consent.
Who cannot join
- Anxiety, depression, or stress based on the Depression Anxiety and Stress Scales 21 (DASS-21).
- Presence of disorders or use of medications affecting body temperature.
- Received any form of heat therapy for the lower back within the past week (e.g., acupuncture, heat pads, patches, massage).
- Applied chemical or pharmaceutical products to the skin area under investigation prior to the study.
- Current disorders or pathologies in the lumbar region.
- Engaged in nighttime activities or experienced insomnia the night before the research day.
Show all 14Show fewer
- Participated in sports activities within 2 hours before the study.
- Used stimulants within 24 hours prior.
- History of alcohol or substance addiction.
- History of hypersensitivity reactions to any form of acupuncture.
- Existing injuries or lesions at acupoints and areas investigated in this study.
- Women currently menstruating, pregnant, or breastfeeding.
- Prior experience with auricular therapies.
- Currently participating in other intervention studies.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Faculty of Traditional medicine, University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City, 700000
About this study
Official title: Changes in Skin Surface Temperature of the Lumbar Region During Auricular Acupressure at Kidney Point on Healthy Volunteers
In Traditional Medicine, auricular acupressure (AA) is one of the non-pharmacological treatment methods commonly utilized due to its safety and convenience. AA involves the application of a taped seed of Vaccaria (with a diameter of 2mm) on specific ear acupoints to manage various disorders. Among these, chronic lower back pain is prevalent. According to Traditional Medicine, the Kidney point is selected for this condition due to the belief that "The lumbar region is the house of the Kidneys". However, evidence supporting this correlation is still lacking. In this study, the aim is to assess the relationship between the Kidney point and the lumbar region by monitoring changes in skin temperature through the application of AA on this acupoint.
Read the detailed description
Healthy volunteers meeting all selection criteria and not violating exclusion criteria will be recruited for the study.
Before commencement, participants will acclimate to the environment for 15 minutes, allowing stabilization of blood pressure, heart rate, respiratory rate, and body temperature. The room will be enclosed and shielded, ensuring no direct sunlight or other radiation sources enter. Room temperature, pressure, humidity, and ventilation will be consistently maintained throughout the study.
The participants will be randomly divided into two groups: one receiving auricular acupressure (AA) first followed by sham auricular acupressure (SA) (AA-SA group), while the other group will receive SA first followed by AA (SA-AA group).
Blood pressure, heart rate, respiratory rate, body temperature, lumbar region temperature, and side effects of auricular therapies will be continuously monitored.
- Conditions
- Temperature Change, Body
- Being tested
- Auricular acupressure on the left ear, Auricular acupressure on the right ear, Sham auricular acupressure
- Medical subject headings
- Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular acupressure on the left earProcedure or surgery
Auricular acupressure is applied at the Kidney point on the left ear using a tape with a Vaccaria seed (2mm in diameter). After placement on this acupoint, apply consistent moderate pressure for 5 minutes.
Auricular acupressure on the right earProcedure or surgery
Auricular acupressure is applied at the Kidney point on the right ear using a tape with a Vaccaria seed (2mm in diameter). After placement on this acupoint, apply consistent moderate pressure for 5 minutes.
Sham auricular acupressureProcedure or surgery
Sham auricular acupressure is applied at Kidney point on the left ear using a tape without any seed. After placement on this acupoint, apply consistent moderate pressure for 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| AA-SA | Experimental | Order: auricular acupressure on the left ear, auricular acupressure on the right ear, sham auricular acupressure on the left ear.
There will be a 30-minute break between each stage. Receives: Procedure: Auricular acupressure on the left ear; Procedure: Auricular acupressure on the right ear; Procedure: Sham auricular acupressure |
| SA-AA | Experimental | Order: sham auricular acupressure on the left ear, auricular acupressure on the right ear, auricular acupressure on the left ear.
There will be a 30-minute break between each stage. Receives: Procedure: Auricular acupressure on the left ear; Procedure: Auricular acupressure on the right ear; Procedure: Sham auricular acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in temperature of the left lumbar region
The temperature of the lumbar region is recorded using an infrared thermal imaging camera. The unit is degrees Celsius (°C).
Measured: During procedure
Change in temperature of the right lumbar region
The temperature of the lumbar region is recorded using an infrared thermal imaging camera. The unit is degrees Celsius (°C).
Measured: During procedure
Secondary outcomes (1)
The proportion of auricular acupuncture side effects
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 Dec 2023
- Study start14 Dec 2023
- Primary completion28 Apr 2024
- Study completion28 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Temperature Change, BodyStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 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
- NCT06169098
- Sponsor's protocol ID
- 699/HDDD-DHYD
- Status last verified
- Apr 2024
- First submitted
- 28 Nov 2023
- Last updated
- 30 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Moura CC, Chaves ECL, Chianca TCM, Ruginsk SG, Nogueira DA, Souza VHS, Iunes DH. Contribution of Chinese and French ear acupuncture for the management of chronic back pain: A randomised controlled trial. J Clin Nurs. 2019 Nov;28(21-22):3796-3806. doi: 10.1111/jocn.14983. Epub 2019 Aug 9.
PubMed 31237981Guan 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 25745463Fan AY, Miller DW, Bolash B, Bauer M, McDonald J, Faggert S, He H, Li YM, Matecki A, Camardella L, Koppelman MH, Stone JAM, Meade L, Pang J. Acupuncture's Role in Solving the Opioid Epidemic: Evidence, Cost-Effectiveness, and Care Availability for Acupuncture as a Primary, Non-Pharmacologic Method for Pain Relief and Management-White Paper 2017. J Integr Med. 2017 Nov;15(6):411-425. doi: 10.1016/S2095-4964(17)60378-9.
PubMed 29103410Hou 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 26823672Moura CC, Iunes DH, Ruginsk SG, Souza VHS, Assis BB, Chaves ECL. Action of ear acupuncture in people with chronic pain in the spinal column: a randomized clinical trial1. Rev Lat Am Enfermagem. 2018 Sep 3;26:e3050. doi: 10.1590/1518-8345.2678.3050.
PubMed 30183875Tan JY, Molassiotis A, Wang T, Suen LK. Adverse events of auricular therapy: a systematic review. Evid Based Complement Alternat Med. 2014;2014:506758. doi: 10.1155/2014/506758. Epub 2014 Nov 10.
PubMed 25435890Gao XY, Zhang SP, Zhu B, Zhang HQ. Investigation of specificity of auricular acupuncture points in regulation of autonomic function in anesthetized rats. Auton Neurosci. 2008 Feb 29;138(1-2):50-6. doi: 10.1016/j.autneu.2007.10.003.
PubMed 18068545He W, Wang X, Shi H, Shang H, Li L, Jing X, Zhu B. Auricular acupuncture and vagal regulation. Evid Based Complement Alternat Med. 2012;2012:786839. doi: 10.1155/2012/786839. Epub 2012 Nov 27.
PubMed 23304215Morrison SF, Nakamura K. Central Mechanisms for Thermoregulation. Annu Rev Physiol. 2019 Feb 10;81:285-308. doi: 10.1146/annurev-physiol-020518-114546. Epub 2018 Sep 26.
PubMed 30256726
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Skin Surface Temperature of the Lumbar Region During Auricular Acupressure at Kidney Point on Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06169098
- Acronym / sponsor ID
- 699/HDDD-DHYD
- Conditions
- Temperature Change, Body
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 14 Dec 2023 (actual)
- Primary completion
- 28 Apr 2024 (actual)
- Study completion
- 28 Apr 2024 (actual)
- First posted
- 13 Dec 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.
In Traditional Medicine, auricular acupressure (AA) is one of the non-pharmacological treatment methods commonly utilized due to its safety and convenience. AA involves the application of a taped seed of Vaccaria (with a diameter of 2mm) on specific ear acupoints to manage various disorders. Among these, chronic lower back pain is prevalent. According to Traditional Medicine, the Kidney point is selected for this condition due to the belief that "The lumbar region is the house of the Kidneys". However, evidence supporting this correlation is still lacking. In this study, the aim is to assess the relationship between the Kidney point and the lumbar region by monitoring changes in skin temperature through the application of AA on this acupoint.
Detailed description
Healthy volunteers meeting all selection criteria and not violating exclusion criteria will be recruited for the study.
Before commencement, participants will acclimate to the environment for 15 minutes, allowing stabilization of blood pressure, heart rate, respiratory rate, and body temperature. The room will be enclosed and shielded, ensuring no direct sunlight or other radiation sources enter. Room temperature, pressure, humidity, and ventilation will be consistently maintained throughout the study.
The participants will be randomly divided into two groups: one receiving auricular acupressure (AA) first followed by sham auricular acupressure (SA) (AA-SA group), while the other group will receive SA first followed by AA (SA-AA group).
Blood pressure, heart rate, respiratory rate, body temperature, lumbar region temperature, and side effects of auricular therapies will be continuously monitored.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AA-SA | Experimental | Procedure: Auricular acupressure on the left ear, Procedure: Auricular acupressure on the right ear, Procedure: Sham auricular acupressureOrder: auricular acupressure on the left ear, auricular acupressure on the right ear, sham auricular acupressure on the left ear. There will be a 30-minute break between each stage. |
| SA-AA | Experimental | Procedure: Auricular acupressure on the left ear, Procedure: Auricular acupressure on the right ear, Procedure: Sham auricular acupressureOrder: sham auricular acupressure on the left ear, auricular acupressure on the right ear, auricular acupressure on the left ear. There will be a 30-minute break between each stage. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI between 18.5 and 23 kg/m2.
- Demonstrates alertness and cooperativeness.
- Vital signs within normal limits.
- Voluntary informed consent.
Key exclusion criteria (14 listed)
- Anxiety, depression, or stress based on the Depression Anxiety and Stress Scales 21 (DASS-21).
- Presence of disorders or use of medications affecting body temperature.
- Received any form of heat therapy for the lower back within the past week (e.g., acupuncture, heat pads, patches, massage).
- Applied chemical or pharmaceutical products to the skin area under investigation prior to the study.
- Current disorders or pathologies in the lumbar region.
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 acupressure on the left earAuricular acupressure is applied at the Kidney point on the left ear using a tape with a Vaccaria seed (2mm in diameter). After placement on this acupoint, apply consistent moderate pressure for 5 minutes. | Procedure or surgery | AA-SA, SA-AA |
| Auricular acupressure on the right earAuricular acupressure is applied at the Kidney point on the right ear using a tape with a Vaccaria seed (2mm in diameter). After placement on this acupoint, apply consistent moderate pressure for 5 minutes. | Procedure or surgery | AA-SA, SA-AA |
| Sham auricular acupressureSham auricular acupressure is applied at Kidney point on the left ear using a tape without any seed. After placement on this acupoint, apply consistent moderate pressure for 5 minutes. | Procedure or surgery | AA-SA, SA-AA |
Primary outcome
Change in temperature of the left lumbar region
Time frame: During procedure
The temperature of the lumbar region is recorded using an infrared thermal imaging camera. The unit is degrees Celsius (°C).
Change in temperature of the right lumbar region
Time frame: During procedure
The temperature of the lumbar region is recorded using an infrared thermal imaging camera. The unit is degrees Celsius (°C).
1 secondary outcome
The proportion of auricular acupuncture side effects
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 30 Apr 2024.
- Background: PubMed 31237981Moura CC, Chaves ECL, Chianca TCM, Ruginsk SG, Nogueira DA, Souza VHS, Iunes DH. Contribution of Chinese and French ear acupuncture for the management of chronic back pain: A randomised controlled trial. J Clin Nurs. 2019 Nov;28(21-22):3796-3806. doi: 10.1111/jocn.14983. Epub 2019 Aug 9.
- 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.
- Background: PubMed 29103410Fan AY, Miller DW, Bolash B, Bauer M, McDonald J, Faggert S, He H, Li YM, Matecki A, Camardella L, Koppelman MH, Stone JAM, Meade L, Pang J. Acupuncture's Role in Solving the Opioid Epidemic: Evidence, Cost-Effectiveness, and Care Availability for Acupuncture as a Primary, Non-Pharmacologic Method for Pain Relief and Management-White Paper 2017. J Integr Med. 2017 Nov;15(6):411-425. doi: 10.1016/S2095-4964(17)60378-9.
- 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 30183875Moura CC, Iunes DH, Ruginsk SG, Souza VHS, Assis BB, Chaves ECL. Action of ear acupuncture in people with chronic pain in the spinal column: a randomized clinical trial1. Rev Lat Am Enfermagem. 2018 Sep 3;26:e3050. doi: 10.1590/1518-8345.2678.3050.
- Background: PubMed 25435890Tan JY, Molassiotis A, Wang T, Suen LK. Adverse events of auricular therapy: a systematic review. Evid Based Complement Alternat Med. 2014;2014:506758. doi: 10.1155/2014/506758. Epub 2014 Nov 10.
- Background: PubMed 18068545Gao XY, Zhang SP, Zhu B, Zhang HQ. Investigation of specificity of auricular acupuncture points in regulation of autonomic function in anesthetized rats. Auton Neurosci. 2008 Feb 29;138(1-2):50-6. doi: 10.1016/j.autneu.2007.10.003.
- Background: PubMed 23304215He W, Wang X, Shi H, Shang H, Li L, Jing X, Zhu B. Auricular acupuncture and vagal regulation. Evid Based Complement Alternat Med. 2012;2012:786839. doi: 10.1155/2012/786839. Epub 2012 Nov 27.
- Background: PubMed 30256726Morrison SF, Nakamura K. Central Mechanisms for Thermoregulation. Annu Rev Physiol. 2019 Feb 10;81:285-308. doi: 10.1146/annurev-physiol-020518-114546. Epub 2018 Sep 26.
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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 on the left ear and Auricular acupressure on the right ear in people with Temperature Change, Body, 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 14 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 30 Apr 2024. 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 in temperature of the left lumbar region (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?
On the ClinicalTrials.gov record for NCT06169098, which also lists 9 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 30 Apr 2024.