Proprioceptive Treatment for Temporomandibular Dysfunction

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Nove de Julho
Sponsor:
Information provided by (Responsible Party):
Daniela Ap. Biasotto-Gonzalez, University of Nove de Julho
ClinicalTrials.gov Identifier:
NCT02021357
First received: December 19, 2013
Last updated: February 4, 2014
Last verified: December 2013
  Purpose

The project aims to assess the effects of treatment proprioceptive through the use of hyperboloid on the intensity of pain, muscle activity, severity and joint mobility in subjects with TMD. Treat will be a blind randomized clinical trial. Will be recruited volunteers aged between 18 and 40 years, with myofascial pain and arthralgia according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC / TMD), being randomly divided in two different groups, the first group constituted by treatment with hyperboloid associated with the exercise of proprioceptive "tongue on the hard palate" and the second group consists of treatment with hyperboloid. The Treatment protocols will be applied for 12 sessions, the volunteers will be evaluated in three stages: before applying the treatment, immediately after the first session and after the last session


Condition Intervention Phase
Facial Pain
Behavioral: hyperboloid associated with the exercise of proprioceptive
Other: hyperboloid
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Influence of Proprioceptive Treatment for the Intensity of Pain, Muscle Activity, Level of Severity and Mandible Mobility in Individuals With Temporomandibular Dysfunction: Clinical Trial, Randomized, Controlled, Double-Blind

Resource links provided by NLM:


Further study details as provided by University of Nove de Julho:

Primary Outcome Measures:
  • Pain [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    The visual analog scale RDC / TMD Pain Index and the Algometry


Secondary Outcome Measures:
  • Electromyographic Activity [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    The EMG signal will be recorded in the dominant upper trapezius muscle in patients with nonspecific neck pain, will be evaluated before and after treatment


Estimated Enrollment: 20
Study Start Date: January 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hyperboloid associated with the exercise of proprioceptive
The proprioceptive treatment protocol if run in the use of exercises with hyperboloid based on studies of Biasotto-Gonzalez (2005), for each exercise will be held 6 sets of 6 reps. Between exercises, 1 minute will be established for rest of the volunteer, in order to avoid muscle fatigue and possible exacerbation of pain, and after that period you will be asked to volunteer the proprioceptive exercise of ´ ´ tongue on the hard palate ´ ´ Biasotto-Gonzalez-based (2005), which consists of the language supported in the hard palate, you must open and close the mouth, having as the principle language as a physical reference.
Behavioral: hyperboloid associated with the exercise of proprioceptive
Active Comparator: Hyperboloid

The proprioceptive treatment protocol if run in the use of the hyperboloid, based on studies of Biasotto-Gonzalez (2005), but without the proprioceptive exercise of language in ´ ´ hard palate ´ ´.

For each exercise will be held 6 series of 6 repetitions, and between exercises, 1 minute will be established for rest of the volunteer, in order to avoid muscle fatigue and possible exacerbation of pain.

Other: hyperboloid

Detailed Description:

The temporomandibular disorder (TMD) are characterized by a set of clinical abnormalities involving the masticatory muscles, the temporomandibular joint (TMJ) and other associated structures. Several studies have supported the use of physical therapy in the treatment of this condition, especially electrotherapy, laser therapy and manual resources. However, despite advances in the search for scientific evidence, it is necessary to prove to other commonly used clinical measures in subjects with TMD, such as the use of hyperboloid, which is a feature that stimulates the proprioceptive function. Thus, this project aims to assess the effects of treatment proprioceptive through the use of hyperboloid on the intensity of pain, muscle activity, severity and joint mobility in subjects with TMD. Treat will be a blind randomized clinical trial. Will be recruited volunteers aged between 18 and 40 years, with myofascial pain and arthralgia according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC / TMD), being randomly divided in two different groups, the first group constituted by treatment with hyperboloid associated with the exercise of proprioceptive "tongue on the hard palate" and the second group consists of treatment with hyperboloid. The Treatment protocols will be applied for 12 sessions, the volunteers will be evaluated in three stages: before applying the treatment, immediately after the first session and after the last session. The variables that will be investigated are: pain assessed using visual analog scale and algometry; muscle activity, investigated by electromyography of masticatory muscles; the severity of TMD, evaluated through the application of anamnestic index of Fonseca, and joint mobility, measured by the use of a caliper. Regarding the analysis of the data will be held intragroup comparisons, considering the pre-treatment, immediately after the first session and after ten sessions, and comparisons between groups. To this end it will be applied the Shapiro-Wilk test for checking the normality of data, and the statistical test applied consistent, then parametric or nonparametric. Is assumed a significance level of 5%.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Temporomandibular Joint Disorders according to the RDC / TMD questionnaire,
  • 18 to 40 years

Exclusion Criteria:

  • History of neurological disorders
  • Submit dental flaws,
  • Sull or partial denture,
  • Systemic diseases, neuromuscular,
  • History of trauma to the face and or ATM
  • History of TMJ luxation.
  • Being in orthodontic treatment or medication that affects the musculoskeletal system.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02021357

Contacts
Contact: Daniela Aparecida Biasotto-Gonzalez 99906-3166 dani_atm@ig.com.br

Locations
Brazil
University of Nove de Julho Recruiting
Sao Paulo, Brazil, 02117-020
Sponsors and Collaborators
University of Nove de Julho
Investigators
Principal Investigator: Eric Arruda University of Nove de Julho
  More Information

Additional Information:
No publications provided

Responsible Party: Daniela Ap. Biasotto-Gonzalez, Doctor of Anatomy, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT02021357     History of Changes
Other Study ID Numbers: ERC-2205-AR
Study First Received: December 19, 2013
Last Updated: February 4, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Nove de Julho:
Facial Pain
Physical Therapy Modalities
Temporomandibular Joint Disorders
Exercise Therapy

Additional relevant MeSH terms:
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Facial Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes

ClinicalTrials.gov processed this record on July 24, 2014