ClinicalTrials.gg
CompletedNCT06169098Updated Apr 30, 2024

Changes in Lumbar Region Temperature During Auricular Acupressure at Kidney Point

An interventional study of Auricular acupressure on the left ear and Auricular acupressure on the right ear in Temperature Change, Body, sponsored by University of Medicine and Pharmacy at Ho Chi Minh City. Completed at 1 site in Vietnam. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-30.

Sponsored by University of Medicine and Pharmacy at Ho Chi Minh City · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Temperature Change, Body
03

In context

Body Temperature Changes

97 studies on the registry are indexed under Body Temperature Changes; 20 are open to participants now.

This study's enrollment of 34 is below the median of 40 across 68 interventional studies indexed under Body Temperature Changes.

Browse Body Temperature Changes studies →

Lead sponsor

University of Medicine and Pharmacy at Ho Chi Minh City is the lead sponsor of 127 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • between 18.5 and 23 kg/m2.
  • Demonstrates alertness and cooperativeness.
  • Vital signs within normal limits.
  • Voluntary .

Exclusion criteria

Exclusion Criteria:

  • 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.
  • Participated in sports activities within 2 hours before the study.
  • Used stimulants within 24 hours prior.
  • History of alcohol or substance addiction.
  • History of 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    AA-SA

    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.

    Procedure: Auricular acupressure on the left ear · Procedure: Auricular acupressure on the right ear · Procedure: Sham auricular acupressure

  • Experimental
    SA-AA

    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.

    Procedure: Auricular acupressure on the left ear · Procedure: Auricular acupressure on the right ear · Procedure: Sham auricular acupressure

Interventions

  • ProcedureAuricular acupressure on the left ear

    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.

  • ProcedureAuricular acupressure on the right ear

    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.

  • ProcedureSham auricular acupressure

    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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: During procedure

  2. 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).

    Time frame: During procedure

Secondary outcomes

  1. The proportion of auricular acupuncture side effects

    Time frame: During procedure

Other outcomes

  1. Change in body temperature

    Body temperature is measured in the armpit using a digital thermometer. The unit is degrees Celsius (°C).

    Time frame: During procedure

  2. Change in heart rate

    The unit is beat per minute (bpm).

    Time frame: During procedure

  3. Change in respiratory rate

    The unit is breath per minute (bpm).

    Time frame: During procedure

  4. Change in blood pressure

    Blood pressure is measured on the arm using an electronic blood pressure monitor, including systolic and diastolic blood pressure. The unit is mmHg.

    Time frame: During procedure

07

Study locations

1 site
  • Faculty of Traditional medicine, University of Medicine and Pharmacy at Ho Chi Minh City
    Ho Chi Minh City, 700000, Vietnam
08

References and documents

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 31237981 ↗
  • Guan 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 ↗
  • Fan 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 29103410 ↗
  • 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 26823672 ↗
  • Moura 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 30183875 ↗
  • Tan 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 25435890 ↗
  • Gao 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 18068545 ↗
  • He 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 23304215 ↗
  • Morrison 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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06169098
Responsible party
Bui Pham Minh Man (Investigator, University of Medicine and Pharmacy at Ho Chi Minh City) — Principal investigator
First posted
Dec 13, 2023
Start date
Dec 14, 2023
Primary completion
Apr 28, 2024
Completion
Apr 28, 2024
Last update
Apr 30, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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