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

Investigate the Change in Facial Pain Threshold During Auricular Acupuncture in Healthy Volunteers: A Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05213299
Enrollment
66
Registered
2022-01-28
Start date
2021-12-25
Completion date
2022-09-15
Last updated
2022-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Auricular Acupuncture

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.

Interventions

PROCEDUREAURICULAR ACUPUNCTURE

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.

OTHERPLACEBO

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

Sponsors

Bui Pham Minh Man
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

2-arm crossover design, randomized controlled trial.

Eligibility

Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
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 procedureEvaluate 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

MeasureTime frameDescription
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 procedureEvaluate 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)

Other

MeasureTime frameDescription
Examine the unfavorable effects during the procedure by using a questionnaireDuring procedureExamine the unfavorable effects during the procedure by using a questionnaire

Countries

Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026