Category
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Primary study
Registry of Trials»Brazilian Registry of Clinical Trials
Year
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2023
INTERVENTION: E02.190.044 E07.710.520 This is a blind and randomized clinical study with a sample age between 18 and 60 years old that will be 18 volunteers divided into 3 groups, attended for 5 weekly sessions: Systemic Acupuncture Group (GAS), Real Laserpuncture Group (GLR) and Laserpuncture Placebo Group (GLP). In the GAS, conventional needling will be performed, in acupoints distant from the face, in the GLR, infrared laser light will be emitted at the same acupoints with a dosage of 2 joules, for 20 seconds per point. In LPG the laser will be used, but it will not be activated.Randomization will be performed by drawing lots before treatment. For this, 3 envelopes of different colors will be used and inside them the marking of which group it belongs to. In the GAS volunteers who will receive treatment with systemic acupuncture, in the acupoints: C8, TA5, R6, VB34, BX64 and E40. GLR volunteers who will receive the application of 2 joules of infrared laser at the same points C8, TA5, R6, VB34, Bx64 and E40. GLP volunteers will receive simulated laser application in the same acupoints. The treatment will be with 1 session per week and 5 sessions will be held. CONDITION: C05.500.607.221.897. Facial Pain; Temporomandibular Joint Disorders PRIMARY OUTCOME: The outcome will be to verify if the stimulation of acupoints with low power laser light will be effective in the management of pain in volunteers with TMD of mixed origin, when acupoints located far from the face are stimulated. SECONDARY OUTCOME: Evaluate the volunteer's expectation and satisfaction following the Likert scale; to assess self‐reported orofacial pain, pressure pain in the central bundle masseter muscles and anterior bundle temporal muscle and change in mouth opening, using the VAS scale; assess mandibular functional limitation using the mandibular functional limitation questionnaire (JFLS: Jaw Functional Limitation Scale); to evaluate the volunteer's emotional alteration through the questionnaire (PHQ‐4: Distress (Depression & Anxiety)) and to evaluate the oral behaviors through the OBC questionnaire: Oral Behaviors Checklist. INCLUSION CRITERIA: Adult volunteers of both sexes, aged 18 to 60 years, with pain due to temporomandibular disorders (TMD) of mixed origin. TMD will be diagnosed by the DC\TMD Diagnostic Criteria for Temporomandibular Disorders (Schiffman, 2014). The mandibular functional limitation questionnaires (JFLS: Jaw Functional Limitation Scale); evaluation of the volunteer's emotional alteration with the questionnaire (PHQ‐4: Distress (Depression & Anxiety)) and the evaluation of oral behaviors by the OBC questionnaire: Oral Behaviors Checklist, will be completed and then the clinical diagnosis of myofacial pain with impairment will be made. of the ATM, characterizing the mixed DTM.
Epistemonikos ID: 93f3aad664c2396dc017c0ecaadb81e2f162aef0
First added on: Feb 20, 2024