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临床试验/NCT02822469
NCT02822469已完成不适用

Thermograph Evaluation of Masticatory Muscles Pre and Post Indirect Physiotherapeutic Treatment in TMD Subjects: A Randomized, Placebo-controlled Study

Daniela Ap. Biasotto-Gonzalez2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Changes in Skin Temperature

研究概览

简要总结

Background: Different therapeutic approaches have been proposed for the treatment of TMD. Myofascial and joint techniques, exercises, intraoral devices, thermal, electro and phototherapy applications, are among the most common. The combination of local treatments and adjacent structures such as the cervical region have also been studied in this area. It is believed that the anatomic proximity, neuronal interconnections and convergent afferents from the trigeminal and cervical areas can lead the understanding of the relationship of these structures. In order to assess the effects of these different forms of treatment studies have used different resources such as diagnostic imaging and biological signals, in order to complement the clinical diagnosis. Infrared thermography has been one of the resource assessment in the literature and it is interesting and stands out from other methods because it is functional, non-invasive and inexpensive.

Purpose: To evaluate the thermograms concerning the masseter and anterior temporal muscles, severity, pain, range of mandibular motion and neck disability in TMD patients, before and after physical therapy applied to the cervical and thoracic regions.

Methods: This is a randomized, placebo-controlled study, designed to evaluate the effects of indirect treatment on the thermography of the masticatory muscles, severity, pain, range of motion and neck disability in individuals with TMD. These will be randomized and allocated into two groups: GA (intervention) and GB (placebo) and assessed as: Diagnostic Criteria for Temporomandibular Research Disorders (RDC/TMD), Fonseca´s Anamnesic Index (FAI), Thermography, EVA, IDD-CF, Pachymetry and Neck Disability Index (NDI).

Statistical analysis: The temperature of the orofacial region, acquired through thermography is considered the primary endpoint and as a secondary endpoint will be the evaluation of the severity according to FAI, pain by VAS and IDD-CF, the range of mandibular motion by pachymetry and neck disability by NDI.

Statistical analysis: The normality of the data will be verified using the Kolmogorov-Smirnov test, which will be expressed as mean and standard deviation and/or median and interquartile range. Repeated measures analysis of variance of two factors, post hoc Bonferroni will be used for inter and intra-group comparisons. The significance level of p≤0.05 is set.

详细描述

This is a randomized, placebo-controlled, study designed to evaluate the thermograms concerning the masseter and anterior temporal muscles, severity, pain, range of mandibular motion and neck disability in TMD patients, before and after physical therapy applied to the cervical and thoracic regions.

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
Single (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

入选标准

  • Age between 18 and 45 years;
  • presence of pain in the facial region in the last 6 months;
  • diagnosis of myofascial pain (I) and/or disc displacement (IIa and IIb) determined by the DRC/TMD; Moderate DTM Record carrier or determined by Fonseca Anamnesic Index.

排除标准

  • A history of trauma/cervical surgery and/or craniofacial;
  • Neurological disorders;
  • cervical disc disease;
  • degenerative diseases of the spine;
  • systemic diseases;
  • diagnosis of fibromyalgia;
  • prior treatments for TMD for the last 3 months;
  • orthodontic treatment/orthopedic in progress;
  • continuous use of analgesics, anti-inflammatories, anxiolytics and/or antidepressants;
  • BMI> 25 kg / m2;
  • pregnancy.

结局指标

主要结局

Changes in Skin Temperature

时间窗: Baseline and 4 weeks

Measured by the Infrared thermographic digital camera

次要结局

  • Changes in TMD severity(Baseline and 4 weeks)
  • Changes in Referred Pain(Baseline and 4 weeks)
  • Changes in Neck disability(Baseline and 4 weeks)
  • Changes in Pain incapacity(Baseline and 4 weeks)
  • Changes in Movement Range of Motion (Opening)(Baseline and 4 weeks)

研究者

发起方
Daniela Ap. Biasotto-Gonzalez
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Daniela Ap. Biasotto-Gonzalez

DR

University of Nove de Julho

研究点 (2)

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