Investigate the Change in Facial Pain Threshold During Auricular Acupuncture in Healthy Volunteers

NCT05213299 | Completed

• 1 other identifier: FWA00023448
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The effects and biological mechanisms of auricular acupuncture on the human body have been increasingly observed in clinical and experimental studies, particularly the analgesic effects. Auricular acupuncture in the Shenmen, Nervous Subcortex, Jaw and Tooth groups has been shown in the Acupuncture 2 textbook of the Faculty of Traditional Medicine - University of Medicine and Pharmacy, Ho Chi Minh City and clinical studies to be effective in reducing facial pain. This study aims to examine: (1) the change in facial pain threshold when performing auricular acupuncture in the acupoints of Shenmen (TF4), Nervous Subcortex (AT4), Jaw (LO3) and Tooth (LO1) on the left ear, (2) the change in facial pain threshold when performing auricular acupuncture in the acupoints of Shenmen, Nervous Subcortex, Jaw and Tooth on the right ear and (3) examining the unfavorable effects of the procedure.

Conditions

Healthy Volunteers

Keywords

Auricular Acupuncture

Outcome Measures

Primary Outcomes (1)

• Evaluate the change of facial pain threshold when using auricular acupuncture and using sham acupuncture in the left ear in healthy volunteers by the multi-capacity digital force gage FDIX of Wagner Inc (Newton Unit of Measurement)

  Evaluate the change of facial pain threshold when using auricular acupuncture and using sham acupuncture in the left ear in healthy volunteers by the multi-capacity digital force gage FDIX of Wagner Inc (Newton Unit of Measurement)

  During procedure

Secondary Outcomes (1)

• Evaluate the change of facial pain threshold when using auricular acupuncture and using sham acupuncture in the right ear in healthy volunteers by the multi-capacity digital force gage FDIX of Wagner Inc (Newton Unit of Measurement)

  During procedure

Other Outcomes (1)

• Examine the unfavorable effects during the procedure by using a questionnaire

  During procedure

Study Arms (2)

First auricular acupuncture, then sham acupuncture in left ear

EXPERIMENTAL

Participants are experienced two phases of our study. The first phase, participants are received auricular acupuncture at TF4, AT4, LO1, LO3 points in the left ear. The second phase, participants are received sham acupuncture at the same points. The facial pain threshold will be recorded before and after performing auricular acupuncture.

Procedure: AURICULAR ACUPUNCTURE; Other: PLACEBO

First auricular acupuncture, then sham acupuncture in right ear

EXPERIMENTAL

Participants are experienced two phases of our study. The first phase, participants are received auricular acupuncture at TF4, AT4, LO1, LO3 points in the right ear. The second phase, participants are received sham acupuncture at the same points. The facial pain threshold will be recorded before and after performing auricular acupuncture.

Procedure: AURICULAR ACUPUNCTURE; Other: PLACEBO

Interventions

AURICULAR ACUPUNCTURE PROCEDURE

Auricular acupuncture is a method for diagnosing and treating physical and psychosomatic dysfunctions by stimulating a specific point in the ear. To conducting this intervention, the investigators use press tack needles to perform auricular acupuncture.

First auricular acupuncture, then sham acupuncture in left ear; First auricular acupuncture, then sham acupuncture in right ear

PLACEBO OTHER

For this intervention, instead of needles, the investigators use four pieces of tape.

First auricular acupuncture, then sham acupuncture in left ear; First auricular acupuncture, then sham acupuncture in right ear

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women between the ages of 18 and 29 who are in good health.
• BMI ranging from 18.5 to 22.9 kg/m2 (classification of IDI \& WPRO for Asians).
• Voluntarily consented to participate in the study, read, was thoroughly explained, and signed the consent form to participate in the study.
• Mental and physical well-being were assessed throughout the study period (on the Depression Anxiety and Stress Scale of 21 with a stress score of 15 points).
• Vital signs are within normal ranges:
• Pulse: 60-100 pulses per minute Systolic blood pressure: 90 to 139 mmHg. Diastolic blood pressure: 60 to 89 mmHg. Temperature: 36.3-37.1 degrees Celsius. At rest, the breathing rate is 16 3 times per minute, and the SpO2 level is 92%.
• \- Volunteers have no other chronic medical conditions: Thyroid disease, autonomic neuropathy, hypertension, diabetes, respiratory diseases (asthma, pneumonia, chronic obstructive pulmonary disease, etc.) etc) by asking for medical history and medical history.

You may not qualify if:

• A feeling of fear or anxiety appeared immediately before the test (rated on the Depression Anxiety and Stress Scale of 21 with stress scores greater than or equal to 15 points).
• Use of stimulants such as alcohol, beer, coffee, and tobacco within 24 hours before the study.
• The auricular skin was examined with lesions (scars, lacerations, scratches, bites).

Sponsors & Collaborators

• Bui Pham Minh Man: lead

Study Sites (1)

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

Ho Chi Minh City, Vietnam

Location

Related Publications (1)

• Ahn C. B., S. J. Lee, J. C. Lee, J. P. Fossion, A. Sant'Ana. A clinical pilot study comparing traditional acupuncture to combined acupuncture for treating headache, trigeminal neuralgia and retro-auricular pain in facial palsy. J Acupunct Meridian Stud. 2011;4(1): 29-43. 2011. De Salles-Neto F. T., J. S. de Paula, Jgaj Romero, C. M. Almeida-Leite. Acupuncture for pain, mandibular function and oral health-related quality of life in patients with masticatory myofascial pain: A randomised controlled trial. J Oral Rehabil. 2020;47(10): 1193-1201. Hou P. W., H. C. Hsu, Y. W. Lin, N. Y. Tang, C. Y. Cheng, C. L. Hsieh. The History, Mechanism, and Clinical Application of Auricular Therapy in Traditional Chinese Medicine. Evid Based Complement Alternat Med. 2015;2015:495684. Iunes D. H., C. Chaves Éde, C. Moura Cde, B. Côrrea, L. C. Carvalho, A. M. Silva, et al. Role of Auriculotherapy in the Treatment of Temporomandibular Disorders with Anxiety in University Students. Evid Based Complement Alternat Med. 2015;2015:430143. Oliveri A. C., J. A. Clelland, J. Jackson, C. Knowles. Effects of auricular transcutaneous electrical nerve stimulation on experimental pain threshold. Phys Ther. 1986 Jan;66(1):12-6. Kaniusas E., S. Kampusch, M. Tittgemeyer, F. Panetsos, R. F. Gines, M. Papa, et al. Current Directions in the Auricular Vagus Nerve Stimulation I - A Physiological Perspective. Front Neurosci. 2019 Aug 9;13:854.

  BACKGROUND

MeSH Terms

Interventions

Acupuncture, Ear

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy

Study Design

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

Model Details: 2-arm crossover design, randomized controlled trial.

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 28, 2022
• Study Start: December 25, 2021
• Primary Completion: July 1, 2022
• Study Completion: September 15, 2022
• Last Updated: December 6, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

VN (1)