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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Examine the unfavorable effects during the procedure by using a questionnaire | Examine the unfavorable effects during the procedure by using a questionnaire | During procedure |
Inclusion Criteria:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Traditional medicine - University of Medicine and Pharmacy of Ho Chi Minh City | Ho Chi Minh City | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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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Demographic characteristic and outcome data will be shared
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| ID | Term |
|---|---|
| D020831 | Acupuncture, Ear |
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D055097 | Auriculotherapy |
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2-arm crossover design, randomized controlled trial.
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| PLACEBO | Other | For this intervention, instead of needles, the investigators use four pieces of tape. |
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| During procedure |