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

Primary Purpose

Temporomandibular Joint Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Manual Therapy Treatment
Placebo Ultrasound
Sponsored by
Daniela Ap. Biasotto-Gonzalez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Dysfunction focused on measuring TMD Infrared Thermography Physical Therapy Modalities

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Nove de Julho

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Manual Therapy Treatment Group

Placebo Ultrasound Treatment Group

Arm Description

Severe and Moderate TMD patients who filled the inclusion criteria who will receive the Manual Therapy Treatment

Severe and Moderate TMD patients who filled the inclusion criteria who will receive the Placebo Treatment.

Outcomes

Primary Outcome Measures

Changes in Skin Temperature
Measured by the Infrared thermographic digital camera

Secondary Outcome Measures

Changes in TMD severity
Measured by Fonseca´s Anamnesic Index
Changes in Neck disability
Measured by the Neck Disability Index
Changes in Pain incapacity
Measured by the IDD-CF
Changes in Movement Range of Motion (Opening)
Measured using a pachymeter (mean values of 3 opening measures)
Changes in Referred Pain
Measured by Visual Analogic Scale

Full Information

First Posted
June 23, 2016
Last Updated
February 18, 2022
Sponsor
Daniela Ap. Biasotto-Gonzalez
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1. Study Identification

Unique Protocol Identification Number
NCT02822469
Brief Title
Thermograph Evaluation of Masticatory and Cervical Muscles After Physiotherapeutic Treatment in Tmd Subjects
Acronym
TEMCMAPTTS
Official Title
Thermograph Evaluation of Masticatory Muscles Pre and Post Indirect Physiotherapeutic Treatment in TMD Subjects: A Randomized, Placebo-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Daniela Ap. Biasotto-Gonzalez

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Dysfunction
Keywords
TMD Infrared Thermography Physical Therapy Modalities

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual Therapy Treatment Group
Arm Type
Experimental
Arm Description
Severe and Moderate TMD patients who filled the inclusion criteria who will receive the Manual Therapy Treatment
Arm Title
Placebo Ultrasound Treatment Group
Arm Type
Placebo Comparator
Arm Description
Severe and Moderate TMD patients who filled the inclusion criteria who will receive the Placebo Treatment.
Intervention Type
Other
Intervention Name(s)
Manual Therapy Treatment
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Placebo Ultrasound
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Skin Temperature
Description
Measured by the Infrared thermographic digital camera
Time Frame
Baseline and 4 weeks
Secondary Outcome Measure Information:
Title
Changes in TMD severity
Description
Measured by Fonseca´s Anamnesic Index
Time Frame
Baseline and 4 weeks
Title
Changes in Neck disability
Description
Measured by the Neck Disability Index
Time Frame
Baseline and 4 weeks
Title
Changes in Pain incapacity
Description
Measured by the IDD-CF
Time Frame
Baseline and 4 weeks
Title
Changes in Movement Range of Motion (Opening)
Description
Measured using a pachymeter (mean values of 3 opening measures)
Time Frame
Baseline and 4 weeks
Title
Changes in Referred Pain
Description
Measured by Visual Analogic Scale
Time Frame
Baseline and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela Ap Biasotto-Gonzalez, PHD
Organizational Affiliation
Study Principal Investigator - Universidade Nove de Julho
Official's Role
Study Chair
Facility Information:
Facility Name
University of Nove de Julho
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
01415000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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

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