- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02822469
Thermograph Evaluation of Masticatory and Cervical Muscles After Physiotherapeutic Treatment in Tmd Subjects (TEMCMAPTTS)
Thermograph Evaluation of Masticatory Muscles Pre and Post Indirect Physiotherapeutic Treatment in TMD Subjects: A Randomized, Placebo-controlled Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
São Paulo
-
Sao Paulo, São Paulo, Brazil, 01415000
- University of Nove de Julho
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Manual Therapy Treatment Group
Severe and Moderate TMD patients who filled the inclusion criteria who will receive the 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Skin Temperature
Time Frame: Baseline and 4 weeks
|
Measured by the Infrared thermographic digital camera
|
Baseline and 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in TMD severity
Time Frame: Baseline and 4 weeks
|
Measured by Fonseca´s Anamnesic Index
|
Baseline and 4 weeks
|
Changes in Neck disability
Time Frame: Baseline and 4 weeks
|
Measured by the Neck Disability Index
|
Baseline and 4 weeks
|
Changes in Pain incapacity
Time Frame: Baseline and 4 weeks
|
Measured by the IDD-CF
|
Baseline and 4 weeks
|
Changes in Movement Range of Motion (Opening)
Time Frame: Baseline and 4 weeks
|
Measured using a pachymeter (mean values of 3 opening measures)
|
Baseline and 4 weeks
|
Changes in Referred Pain
Time Frame: Baseline and 4 weeks
|
Measured by Visual Analogic Scale
|
Baseline and 4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Daniela Ap Biasotto-Gonzalez, PHD, Study Principal Investigator - Universidade Nove de Julho
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2YEH1984
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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