Thermograph Evaluation of Masticatory and Cervical Muscles After Physiotherapeutic Treatment in Tmd Subjects

NCT02822469 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-02-21

No results posted yet for this study

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.

Conditions

  • Temporomandibular Joint Dysfunction

Interventions

OTHER

Manual Therapy Treatment

Treatment starts with 10 deep breathing movements for global relaxation. The anterior and posterior neck muscles, shoulder girdle and subdiaphragmatic will be addressed with myofascial techniques repeated 10 times in each stroke. The cervical spine will be pulled in the longitudinal direction. The draw will be held 1 time, lasting 1 minute. The thoracic region will receive mobilization technique in the anteroposterior direction,10 repeated movements involving all thoracic segment. The treatment will be applied previously trained therapists, 4 weeks, 2 times a week, totaling eight sessions. The treatment time per session is about 25 minutes.

DEVICE

Placebo Ultrasound

A detuned pulsed ultrasound will be applied to regions of the muscles around the shoulder girdle and anterior posterior cervical, for 25 minutes (2.5 minutes in each zone ). The device will be used with the internal cables disconnected for the placebo effect . However, you can handle it and adjust the doses and alarms as it is connected in order to simulate clinical practice and increase the credibility of the use of this device in the voluntary . The placebo treatment will be applied by previously trained therapists. Treatment will have 4 weeks, 2 times a week, totaling eight sessions.

Sponsors & Collaborators

  • Daniela Ap. Biasotto-Gonzalez

    lead OTHER

Principal Investigators

  • Daniela Ap Biasotto-Gonzalez, PHD · Study Principal Investigator - Universidade Nove de Julho

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-10-31
Completion
2017-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02822469 on ClinicalTrials.gov