Thermograph Evaluation of Masticatory and Cervical Muscles After Physiotherapeutic Treatment in Tmd Subjects (TEMCMAPTTS)
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|ClinicalTrials.gov Identifier: NCT02822469|
Recruitment Status : Unknown
Verified June 2016 by Daniela Ap. Biasotto-Gonzalez, University of Nove de Julho.
Recruitment status was: Not yet recruiting
First Posted : July 4, 2016
Last Update Posted : July 4, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Temporomandibular Joint Dysfunction||Other: Manual Therapy Treatment Device: Placebo Ultrasound||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Thermograph Evaluation of Masticatory Muscles Pre and Post Indirect Physiotherapeutic Treatment in TMD Subjects: A Randomized, Placebo-controlled Study|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||October 2016|
|Estimated Study Completion Date :||December 2016|
Experimental: Manual Therapy Treatment Group
Severe and Moderate TMD patients who filled the inclusion criteria who will receive the Manual Therapy Treatment
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.
Placebo Comparator: Placebo Ultrasound Treatment Group
Severe and Moderate TMD patients who filled the inclusion criteria who will receive the Placebo Treatment.
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.
- Changes in Skin Temperature [ Time Frame: Baseline and 4 weeks ]Measured by the Infrared thermographic digital camera
- Changes in TMD severity [ Time Frame: Baseline and 4 weeks ]Measured by Fonseca´s Anamnesic Index
- Changes in Neck disability [ Time Frame: Baseline and 4 weeks ]Measured by the Neck Disability Index
- Changes in Pain incapacity [ Time Frame: Baseline and 4 weeks ]Measured by the IDD-CF
- Changes in Movement Range of Motion (Opening) [ Time Frame: Baseline and 4 weeks ]Measured using a pachymeter (mean values of 3 opening measures)
- Changes in Referred Pain [ Time Frame: Baseline and 4 weeks ]Measured by Visual Analogic Scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02822469
|Contact: Daniela Ap Biasotto-Gonzalez, PHD||+55 11 firstname.lastname@example.org|
|University of Nove de Julho|
|Sao Paulo, São Paulo, Brazil, 01415000|
|Study Chair:||Daniela Ap Biasotto-Gonzalez, PHD||Study Principal Investigator - Universidade Nove de Julho|