Clinical trial NCT06169098: Changes in Lumbar Region Temperature During Auricular Acupressure at Kidney Point
Official title: Changes in Skin Surface Temperature of the Lumbar Region During Auricular Acupressure at Kidney Point on Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temperature Change, Body
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in temperature of the left lumbar region
timeFrame: During procedure
measure: Change in temperature of the right lumbar region
timeFrame: During procedure
Secondary outcomes:
measure: The proportion of auricular acupuncture side effects
timeFrame: During procedure
Other outcomes:
measure: Change in body temperature
timeFrame: During procedure
measure: Change in heart rate
timeFrame: During procedure
measure: Change in respiratory rate
timeFrame: During procedure
measure: Change in blood pressure
timeFrame: During procedure
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Faculty of Traditional medicine, University of Medicine and Pharmacy at Ho Chi Minh City
Study officials:
References:
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