Herpich Carolina Marciela, Leal-Junior Ernesto Cesar Pinto, Amaral Ana Paula, Tosato Juliana de Paiva, Glória Igor Phillip dos Santos, Garcia Marília Barbosa Santos, Barbosa Bruno Roberto Borges, El Hage Yasmin, Arruda Éric Edmur Camargo, Gomes Cid Ándre Fidelis de Paula, Rodrigues Monique Sampaio, de Sousa Dowglas Fernando Magalhães, de Carvalho Paulo de Tarso Camillo, Bussadori Sandra Kalil, Gonzalez Tabajara de Oliveira, Politti Fabiano, Biasotto-Gonzalez Daniela Aparecida
Student, Postgraduate Program in Rehabilitation Sciences, Center for Support to Research on Movement Analysis, University Nove de Julho (UNINOVE), Rua Profa Maria Jose Barone Fernandes, 300, São Paulo, SP 02117-020, Brazil.
Trials. 2014 Dec 16;15:491. doi: 10.1186/1745-6215-15-491.
According to the International Association for the Study of Pain (IASP), the term temporomandibular disorder (TMD) regards a subgroup of orofacial pain, the symptoms of which include pain or discomfort in the temporomandibular joint, ears, masticatory muscles and neck on one or both sides, as well as joint sounds, limited mandibular movements or mandibular deviation and difficulties chewing. Phototherapy, such as low-level laser therapy (LLLT) and light-emitting diode (LED) therapy, is one of the resources used to treatment muscle pain. Thus, there is a need to investigate therapeutic resources that combine different wavelengths as well as different light sources (LLLT and LED) in the same apparatus. The aim of the proposed study is to evaluate the effects of four different doses of phototherapy on pain, activity of the masticatory muscles (masseter and bilateral anterior temporal) and joint mobility in individuals with temporomandibular disorder. A further aim is to determine the cumulative effect 24 and 48 hours after a single session.
METHODS/DESIGN: A placebo-controlled, double-blind, randomized, clinical trial will be carried out involving 72 women between 18 and 40 years of age with a diagnosis of myogenous TMD. The participants will then be randomly allocated to four groups totaling 18 individuals per group. Three groups will be submitted to a single session of phototherapy with different light sources, and one group will receive placebo therapy: Group A (2.62 Joules); Group B (5.24 Joules); Group C (7.86 Joules); and Group D (0 Joules). The following assessment tools will be administered on four separate occasions (baseline and immediately after, 24 h after and 48 h after phototherapy). Pain intensity will be assessed using the visual analog scale for pain, while pain thresholds will be determined using algometer, and electromyographic (EMG) analysis on the masseter and anterior temporal muscles.
The study will contribute to the practice of the evidence-based use of phototherapy in individuals with a myogenous TMD. Data will be published after the study is completed.
This study is registered with the Brazilian Registry of Clinical Trials, NCT02018770, date of registration: 7 December 2013.
根据国际疼痛研究协会（IASP）的定义，颞下颌关节紊乱病（TMD）是口面部疼痛的一个亚组，其症状包括一侧或双侧颞下颌关节、耳部、咀嚼肌和颈部疼痛或不适，以及关节弹响、下颌运动受限或下颌偏斜和咀嚼困难。光疗法，如低强度激光疗法（LLLT）和发光二极管（LED）疗法，是用于治疗肌肉疼痛的方法之一。因此，有必要研究在同一设备中结合不同波长以及不同光源（LLLT和LED）的治疗方法。本研究的目的是评估四种不同剂量的光疗法对颞下颌关节紊乱病患者疼痛、咀嚼肌（咬肌和双侧颞肌前部）活动及关节活动度的影响。另一个目的是确定单次治疗后24小时和48小时的累积效应。
方法/设计：将进行一项安慰剂对照、双盲、随机临床试验，纳入72名年龄在18至40岁之间、诊断为肌源性TMD的女性。参与者将被随机分为四组，每组18人。三组将接受不同光源的单次光疗法治疗，一组接受安慰剂治疗：A组（2.62焦耳）；B组（5.24焦耳）；C组（7.86焦耳）；D组（0焦耳）。将在四个不同时间（基线、光疗后即刻、光疗后24小时和光疗后48小时）使用以下评估工具。疼痛强度将使用视觉模拟疼痛量表进行评估，疼痛阈值将使用痛觉计进行测定，并对咬肌和颞肌前部进行肌电图（EMG）分析。
本研究将有助于为肌源性TMD患者循证使用光疗法提供实践依据。研究完成后将公布数据。
本研究已在巴西临床试验注册中心注册，注册号为NCT02018770，注册日期：2013年12月7日。
