Changes in Lumbar Region Temperature During Auricular Acupressure at Kidney Point

NCT ID: NCT06169098

Last Updated: 2024-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-14

Study Completion Date

2024-04-28

Brief Summary

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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

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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.

Conditions

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Temperature Change, Body

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Auricular acupressure on the left ear

Intervention Type 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

Intervention Type 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

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Auricular acupressure on the left ear

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Medicine and Pharmacy at Ho Chi Minh City

OTHER

Sponsor Role lead

Responsible Party

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Bui Pham Minh Man

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Ho Chi Minh City, , Vietnam

Site Status

Countries

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Vietnam

References

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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.

Reference Type BACKGROUND
PMID: 31237981 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25745463 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29103410 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26823672 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30183875 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25435890 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18068545 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23304215 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30256726 (View on PubMed)

Other Identifiers

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699/HDDD-DHYD

Identifier Type: -

Identifier Source: org_study_id

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