Changes in Lumbar Region Temperature During Auricular Acupressure at Kidney Point

NCT06169098 | Completed

• 1 other identifier: 699/HDDD-DHYD
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Temperature Change, Body

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• The proportion of auricular acupuncture side effects

  During procedure

Other Outcomes (4)

• Change in body temperature

  During procedure

• Change in heart rate

  During procedure

• Change in respiratory rate

  During procedure

Study Arms (2)

AA-SA

EXPERIMENTAL

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

SA-AA

EXPERIMENTAL

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

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.

AA-SA; SA-AA

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.

AA-SA; SA-AA

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.

AA-SA; SA-AA

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Ho Chi Minh City, 700000, Vietnam

Location

Related Publications (9)

• 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.

  PMID: 31237981 BACKGROUND

• 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.

  PMID: 25745463 BACKGROUND

• 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.

  PMID: 29103410 BACKGROUND

• 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.

  PMID: 26823672 BACKGROUND

• 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.

  PMID: 30183875 BACKGROUND

• 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.

  PMID: 25435890 BACKGROUND

• 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.

  PMID: 18068545 BACKGROUND

• 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.

  PMID: 23304215 BACKGROUND

• 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.

  PMID: 30256726 BACKGROUND

MeSH Terms

Conditions

Body Temperature Changes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 13, 2023
• Study Start: December 14, 2023
• Primary Completion: April 28, 2024
• Study Completion: April 28, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

VN (1)