Clinical trial NCT02822469: Thermograph Evaluation of Masticatory and Cervical Muscles After Physiotherapeutic Treatment in Tmd Subjects
Official title: Thermograph Evaluation of Masticatory Muscles Pre and Post Indirect Physiotherapeutic Treatment in TMD Subjects: A Randomized, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Joint Dysfunction
Keywords: TMD Infrared Thermography Physical Therapy Modalities
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2016-07-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Changes in Skin Temperature
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Changes in TMD severity
timeFrame: Baseline and 4 weeks
measure: Changes in Neck disability
timeFrame: Baseline and 4 weeks
measure: Changes in Pain incapacity
timeFrame: Baseline and 4 weeks
measure: Changes in Movement Range of Motion (Opening)
timeFrame: Baseline and 4 weeks
measure: Changes in Referred Pain
timeFrame: Baseline and 4 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Nove de Julho
state: São Paulo
Study officials:
affiliation: Study Principal Investigator - Universidade Nove de Julho
name: Daniela Ap Biasotto-Gonzalez, PHD
role: STUDY_CHAIR
References: