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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
Sponsor:
Information provided by (Responsible Party):
Daniela Ap. Biasotto-Gonzalez, University of Nove de Julho

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.


Condition or disease Intervention/treatment Phase
Temporomandibular Joint Dysfunction Other: Manual Therapy Treatment Device: Placebo Ultrasound Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

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
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.




Primary Outcome Measures :
  1. Changes in Skin Temperature [ Time Frame: Baseline and 4 weeks ]
    Measured by the Infrared thermographic digital camera


Secondary Outcome Measures :
  1. Changes in TMD severity [ Time Frame: Baseline and 4 weeks ]
    Measured by Fonseca´s Anamnesic Index

  2. Changes in Neck disability [ Time Frame: Baseline and 4 weeks ]
    Measured by the Neck Disability Index

  3. Changes in Pain incapacity [ Time Frame: Baseline and 4 weeks ]
    Measured by the IDD-CF

  4. Changes in Movement Range of Motion (Opening) [ Time Frame: Baseline and 4 weeks ]
    Measured using a pachymeter (mean values of 3 opening measures)

  5. Changes in Referred Pain [ Time Frame: Baseline and 4 weeks ]
    Measured by Visual Analogic Scale



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Daniela Ap Biasotto-Gonzalez, PHD +55 11 36659325 biasottogonzalez@gmail.com

Locations
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Brazil
University of Nove de Julho
Sao Paulo, São Paulo, Brazil, 01415000
Sponsors and Collaborators
Daniela Ap. Biasotto-Gonzalez
Investigators
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Study Chair: Daniela Ap Biasotto-Gonzalez, PHD Study Principal Investigator - Universidade Nove de Julho

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Responsible Party: Daniela Ap. Biasotto-Gonzalez, DR, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT02822469     History of Changes
Other Study ID Numbers: 2YEH1984
First Posted: July 4, 2016    Key Record Dates
Last Update Posted: July 4, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Daniela Ap. Biasotto-Gonzalez, University of Nove de Julho:
TMD Infrared Thermography Physical Therapy Modalities

Additional relevant MeSH terms:
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Joint Diseases
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Musculoskeletal Diseases
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes