Auriculotherapy
Conditions
Interventions
A randomized, two-arm, triple-blind, sham-controlled clinical trial was conducted. Fourteen volunteers were randomized into two groups: Auriculotherapy Group - AG, who received treatment via auriculot
and Sham Group - SG, who received treatment at acupoints unrelated to their complaints: immunity, shoulder, and finger. Both groups received one session per week for eight consecutive weeks. Pain was
Sponsors
Universidade Estadual de Ponta Grossa
Universidade Estadual de Ponta Grossa
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Age range of 18 to 60 years, both male and female, and presents with Temporomandibular Dysfunction with myofascial pain according to the Research Diagnostic Criteria for Temporomandibular Disorders, which has been translated and validated in Portuguese for use in the Brazilian population. This criterion is composed of two axes. Axis I evaluates the clinical and physical aspects of temporomandibular disorders, including muscle and joint examination, limitation of mandibular movements, and presence of pain on palpation. Axis II investigates the psychosocial aspects and the impact of chronic pain, through the evaluation of depression, somatization, and pain-related disability. This system allows for a more precise and reproducible diagnostic classification of individuals with Temporomandibular Dysfunction
Exclusion criteria
Exclusion criteria: Non-painful temporomandibular dysfunction according to the Diagnostic Criteria for Temporomandibular Disorders Research; previous prosthetic rehabilitation; associated diseases such as fibromyalgia, facial paralysis, rheumatoid arthritis, cognitive deficits that would hinder the understanding of some stages of the research; pregnancy; external ear injuries; immunocompromised state; coagulopathies; metabolic disease; vascular disease or neoplasia; continuous use of medications, for example, antidepressants, anxiolytics and anticonvulsants; and recent use of medications that interfere with pain perception, such as analgesics, anti-inflammatories and muscle relaxants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1 The intensity of chronic pain will be assessed through records made by volunteers using the VAS visual analog scale - 0-100. The values ??will be presented as mean and standard deviation for the different periods evaluated - before auriculotherapy and before the fourth and eighth sessions. A reduction in pain intensity was expected at the evaluated times;Outcome found 1 In the assessment of pain intensity, it was observed that, initially, both groups presented similar pain values, with no significant difference p equal 0.79. After four sessions, there was a reduction in pain in both groups, although without statistical significance p equal 0.19. At the end of the eight sessions, however, a significant decrease in pain was observed in the GA 1.8 more or less 0.7 compared to the GS 3.9 more or less 1.4, a statistically significant difference p equal 0.003, indicating greater effectiveness of the protocol applied to the GA | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected Outcome 2 Anxiety symptoms will be assessed using the Generalized Anxiety Disorder Assessment Questionnaire – 7 items GAD-7. A decrease in anxiety symptoms is expected in volunteers who received GA auriculotherapy treatment compared to Sham GS treatment. Participants' anxiety levels were checked before the start of auriculotherapy, and before the fourth and eighth auriculotherapy sessions. A 20 percent decrease is expected compared to the control group.;Outcome found 2 Regarding anxiety, the groups presented similar scores at the beginning of the research: GA: 18.3 more or less 1.7 and GS: 18.3 more or less 1.6, p equal to 0.97. However, after four sessions, GA showed a significant reduction in anxiety: GA: 7.3 more or less 2.0 and GS: 16.7 more or less 1.3, p less than 0.001, and after the eighth session, GA showed an even greater reduction, in contrast to GS: GA: 4.1 more or less 0.8 and GS: 13.6 more or less 4.7, p less than 0.001.;Expected outcome 3 To assess the degree of mouth opening, the edges of the upper and lower central incisors will be measured using a flexible ruler. The degree of mouth opening will be evaluated before the start of auriculotherapy and before the fourth and eighth auriculotherapy sessions. It is expected that the measurement in millimeters in the GA group will be greater than that found in the GS group;Outcome found 3 Regarding mouth opening, no statistically significant differences were observed between the groups at any of the evaluated time points p greater than 0.05. Although the GS group showed slightly higher averages than the GA group, these variations were not sufficient to demonstrate a significant impact of the intervention on this variable | — |
Countries
BR
Contacts
Public ContactLuciana Martins
Universidade Estadual de Ponta Grossa
Outcome results
None listed