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

Primary Purpose

Healthy Volunteers

Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
AURICULAR ACUPUNCTURE
PLACEBO
Sponsored by
Bui Pham Minh Man
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy Volunteers focused on measuring Auricular Acupuncture

Eligibility Criteria

18 Years - 29 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

First auricular acupuncture, then sham acupuncture in left ear

First auricular acupuncture, then sham acupuncture in right ear

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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)

Full Information

First Posted
December 21, 2021
Last Updated
December 3, 2022
Sponsor
Bui Pham Minh Man
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1. Study Identification

Unique Protocol Identification Number
NCT05213299
Brief Title
Investigate the Change in Facial Pain Threshold During Auricular Acupuncture in Healthy Volunteers
Official Title
Investigate the Change in Facial Pain Threshold During Auricular Acupuncture in Healthy Volunteers: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
December 25, 2021 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
September 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bui Pham Minh Man

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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. When the downward neurotransmitter pathway is activated, endogenous opioids (beta endorphins) are released, which inhibit pain perception. Furthermore, according to the gate control theory (spinal segmentation mechanism), auricular acupuncture aids in the activation of pain-suppressive stimuli by myelinated afferent fibers (Aβ), as opposed to stimuli with damage from poorly myelinated (Aδ) or unmyelinated (C) fibers. Besides, according to human physiology, the trigeminal nerve is involved in sensory control of the face, has a branching distribution to the skin of the pinna, and has afferent conduction of mechanical stimuli acting on it. 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 was the first study in Vietnam to investigate the effect of auricular acupuncture on the change in facial pain threshold during auricular acupuncture on acupoints such as Shenmen, Nervous Subcortex, Jaw and Tooth. The findings of the study can be used to supplement scientific evidence regarding the effects of auricular acupuncture in the treatment of clinical facial pain. The investigators performed a randomized, controlled crossover experiments. A crossover study has two advantages over both a parallel study and a non-crossover longitudinal study. First, the influence of confounding covariates is reduced because each crossover patient serves as their own control. In a randomized non-crossover study it is often the case that different treatment-groups are found to be unbalanced on some covariates. In a controlled, randomized crossover designs, such imbalances are implausible (unless covariates were to change systematically during the study). Second, optimal crossover designs are statistically efficient, and so require fewer subjects than do non-crossover designs (even other repeated measures designs). In our study, the subjects are randomly assigned to two arms of the study which receive different treatments. A crossover trial has a repeated measures design in which each patient is assigned to a sequence of two treatments, one of which is auricular acupuncture, and a placebo test is performed on that volunteer a week later. Wilcoxon sign-rank test, paired T test and Pearson's chi-squared test were used for comparison of means.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers
Keywords
Auricular Acupuncture

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
2-arm crossover design, randomized controlled trial.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
First auricular acupuncture, then sham acupuncture in left ear
Arm Type
Experimental
Arm Description
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.
Arm Title
First auricular acupuncture, then sham acupuncture in right ear
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
AURICULAR ACUPUNCTURE
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
PLACEBO
Intervention Description
For this intervention, instead of needles, the investigators use four pieces of tape.
Primary Outcome Measure Information:
Title
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)
Description
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)
Time Frame
During procedure
Secondary Outcome Measure Information:
Title
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)
Description
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)
Time Frame
During procedure
Other Pre-specified Outcome Measures:
Title
Examine the unfavorable effects during the procedure by using a questionnaire
Description
Examine the unfavorable effects during the procedure by using a questionnaire
Time Frame
During procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Facility Information:
Facility Name
Faculty of Traditional medicine - University of Medicine and Pharmacy of Ho Chi Minh City
City
Ho Chi Minh City
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Demographic characteristic and outcome data will be shared
Citations:
Citation
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.
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Investigate the Change in Facial Pain Threshold During Auricular Acupuncture in Healthy Volunteers

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