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NCT Number: NCT06169098

Changes in Lumbar Region Temperature During Auricular Acupressure at Kidney Point

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.

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Traditional medicine, University of Medicine and Pharmacy at Ho Chi Minh City

Ho Chi Minh City, 700000, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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 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.

Treatment and study plan

Auricular acupressure on the left ear

Procedure

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 ear

Procedure

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 Acupressure

Procedure

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.

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. The proportion of auricular acupuncture side effects

    Time frame: During procedure

Other outcomes

  1. Change in body temperature

    Time frame: During procedure

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

  2. Change in heart rate

    Time frame: During procedure

    The unit is beat per minute (bpm).

  3. Change in respiratory rate

    Time frame: During procedure

    The unit is breath per minute (bpm).

  4. Change in blood pressure

    Time frame: During procedure

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

Sponsors and collaborators

Lead sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Other

Registry information

Official study title

Changes in Skin Surface Temperature of the Lumbar Region During Auricular Acupressure at Kidney Point on Healthy Volunteers

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 13, 2023
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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