O efeito da auriculoterapia a laser no tratamento da disfunção temporomandibular: estudo de viabilidade randomizado duplo cego.

Abstract

Temporomandibular disorders have a high prevalence in the general population and multifactorial etiology, with orofacial pain being one of the most common complaints. Among the therapeutic options is auriculotherapy, a French technique that believes in improving symptoms in different areas of the body by stimulating specific points on the ear. The literature presents data on the effectiveness of auriculotherapy to reduce musculoskeletal pain and on the improvement of TMD symptoms by applying low-intensity laser. However, studies using laser auriculotherapy to treat this condition are scarce. Objective: To evaluate the feasibility of conducting a randomized clinical trial using an intervention protocol applying laser auriculotherapy with pulsed frequency and to determine the sample size required for the study. Methodology: The study is characterized as a Controlled Randomized Pilot Study. The sample consisted of men and women diagnosed with TMD according to the Temporomandibular Disorders Diagnostic Criteria (DC/TMD), aged between 18 and 60 years. The sample was randomized into two groups: Experimental Group (EG - n=10), which received treatment with pulsed laser acupuncture and Placebo Group (GP - n=11), which received treatment with the

same protocol with the laser device turned off. The groups were evaluated in the pre- intervention and after four appointments. The instruments used for evaluation were: DC/TM

axis I and the following axis II scales: Graded Chronic Pain Scale (GCPS), Mandibular Functional Limitation Scale (JFLS-8), Patient Health Questionnaire (PHQ-4) and Generalized Anxiety Disorder (GAD-7). The Shapiro Wilk test was used to verify the Gaussian distribution. Comparisons between groups were tested using the Mann-Whitney test and comparisons between time using the Wilcoxon test and sample size with α = 0.05 and β = 0.80. Results: The GCPS question about “pain at this exact moment” presents lower values for the treated group compared to the placebo group (U=15.50; p=0.005). The sample calculation was 11 volunteers for each group. The variable JFLS-8 showed that there was no difference between the groups and the calculation of the necessary sample for this variable ranged from 39 to 281 volunteers. The functional limitation variable showed no difference between the groups and the calculation of the necessary sample ranged from 27 to 2,317. The variable PHQ-4 (U=21.00; p=0.02) and GAD-7 (U=20.00; p=0.02) showed differences between groups, however, the differences showed type I error The calculation of the necessary sample was 22 volunteers for variable PHQ-4 and 25 volunteers for variable GAD-7. Conclusion: It is concluded that there is feasibility for carrying out the study and the required sample should be above 22 volunteers.