Magnetic Ressonance Imaging Evaluation of Articular Disc Position in TMD Subjects After Mandibular Mobilization. A Double Blind, Randomized, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Articular Disc Positioning (Measured by the Magnetic Ressonance Imaging)
研究概览
简要总结
Background: Among the instrumental devices that have been proposed over the years to integrate the clinical evaluation of temporomandibular joint disorders (TMD), imaging techniques are the most studied, showing that magnetic resonance imaging (MRI) is the technique most need to describe the anatomy of the TMJ and to evaluate the correlation of imaging findings with the clinical diagnosis . Despite the amount available studies on the use of MRI for evaluation of TMJ disorders and treatments, there is a lack of studies that evaluate the imaging findings after physical therapy. Purpose: To evaluate the influence of nonspecific mandibular mobilization about the positioning of the articular disc by MRI in individuals with TMD diagnosis of anterior disc displacement with and without reduction according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). Analyze the behavior of pain through the numerical scale of pain assessment (END) at baseline and after each treatment session, the quality of life of individuals with TMD at baseline, immediately, three and six months after the treatment sessions by the World Health Organization Quality of Life Assessment (WHOQOL - BREF), and The Patient's Specific Functional Scale (PSFS) at baseline and after treatment. The treatment will be performed three times a week during four weeks. Metodology: This is a randomized, placebo controlled, blind study designed to assess the effects of techniques nonspecific mandibular mobilization x placebo. Individuals will be randomized and divided into two groups: Group A (intervention) and Group B (placebo). Statistic analysis: The positioning of the articular disc, extracted through the use of MRI, will be considered the primary outcome and, as a secondary outcome will be assessed the quality of life, pain and function after treatment. The adherence of the data to a Gaussian curve will be verified by the Shapiro-Wilk and the data are expressed as mean values and standard deviation. Two-way repeated measures analysis of variance with Bonferroni post hoc test will be used for inter-and intra-group comparisons. The significance level is adjusted p ≤ 0.05.
详细描述
This is a randomized, placebo-controlled, double-blind study designed to verify the effects of nonspecific mandibular mobilization techniques x placebo
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •TMD diagnosed subjects by RDC / TMD confirmed by the MRI findings,
- •with anterior disk displacement with or without reduction,
- •with full dentition (excluding third molars).
排除标准
- •Subjects diagnosed TMD exclusively muscular;
- •with posterior and / or medial displacement of the disc;
- •showing systemic diseases that affect the joints and / or masticatory muscles;
- •neuromuscular diseases;
- •hypo / condylar hyperplasia;
- •making use of any type of dental prosthesis;
- •are in orthodontic and / or physical therapy;
- •showing neurological or behavioral disorders that preclude the achievement of MRI and/or
- •a history of previous TMJ surgery.
结局指标
主要结局
Articular Disc Positioning (Measured by the Magnetic Ressonance Imaging)
时间窗: Baseline (day 1) and after 4 weeks of treatment performed 3 times a week.
Measured by the Magnetic Ressonance Imaging
次要结局
- Clinical Symptoms (Measured by END)(Baseline (day 1) and after 4 weeks of treatment performed 3 times a week.)
- Functionality (Mesuread by "The Patient´s Specific Funcional Scale - HORN, 2012)(Baseline (day 1) and after 4 weeks of treatment performed 3 times a week.)
- Quality of life (Whoqol-bref)(Baseline (day 1) and after 4 weeks of treatment (performed 3 times a week), 3 and 6 months follow up)
研究者
Daniela Ap. Biasotto-Gonzalez
Phd
University of Nove de Julho
