Changes in Lumbar Region Temperature During Auricular Acupressure at Kidney Point

Temperature Change, Body Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06169098
• Other study ID #: 699/HDDD-DHYD
• Status: Completed
• Phase: N/A
• Start date: December 14, 2023
• Est. completion date: April 28, 2024

Study information

• Verified date: April 2024
• Source: University of Medicine and Pharmacy at Ho Chi Minh City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 28, 2024
• Est. primary completion date: April 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Temperature Changes
• Temperature Change, Body

Intervention

Procedure:
• Auricular 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.
• Auricular 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.
• Sham 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.

Locations

Country	Name	City	State
Vietnam	Faculty of Traditional medicine, University of Medicine and Pharmacy at Ho Chi Minh City	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
University of Medicine and Pharmacy at Ho Chi Minh City

Country where clinical trial is conducted

Vietnam, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in body temperature	Body temperature is measured in the armpit using a digital thermometer. The unit is degrees Celsius (°C).	During procedure
Other	Change in heart rate	The unit is beat per minute (bpm).	During procedure
Other	Change in respiratory rate	The unit is breath per minute (bpm).	During procedure
Other	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.	During procedure
Primary	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).	During procedure
Primary	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).	During procedure
Secondary	The proportion of auricular acupuncture side effects		During procedure