Changes in Lumbar Region Temperature During Auricular Acupressure at Kidney Point

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.

Study Overview

• Status: Recruiting
• Conditions: Temperature Change, Body
• Intervention / Treatment: Procedure: Auricular acupressure on the left ear; Procedure: Auricular acupressure on the right ear; Procedure: Sham auricular acupressure

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 Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Minh-Man Pham Bui, Medical doctor; Phone Number: +84916080803; Email: bpmman@ump.edu.vn
• Study Contact Backup: Name: Huong-Xuan Thi Nguyen, Medical doctor; Phone Number: +84388916499; Email: nthxuan.ntyhct21@ump.edu.vn

Study Locations

• Vietnam
  • Ho Chi Minh City, Vietnam, 700000
    • Recruiting
    • Faculty of Traditional medicine, University of Medicine and Pharmacy at Ho Chi Minh City
    • Contact: Minh-Man Pham Bui, Medical doctor; Phone Number: +84916080803; Email: bpmman@ump.edu.vn
    • Contact: Huong-Xuan Thi Nguyen, Medical doctor; Phone Number: +84388916499; Email: nthxuan.ntyhct21@ump.edu.vn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.; Procedure: 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.; Procedure: 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.
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; 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.; Procedure: 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.; Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Time Frame
The proportion of auricular acupuncture side effects	During procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body temperature	Body temperature is measured in the armpit using a digital thermometer. The unit is degrees Celsius (°C).	During procedure
Change in heart rate	The unit is beat per minute (bpm).	During procedure
Change in respiratory rate	The unit is breath per minute (bpm).	During procedure
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

Collaborators and Investigators

• Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: November 28, 2023
• First Submitted That Met QC Criteria: December 5, 2023
• First Posted (Actual): December 13, 2023

Study Record Updates

• Last Update Posted (Actual): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Temperature Changes
• Other Study ID Numbers: 699/HDDD-DHYD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No