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Therapeutic Response of Ultrasound and Muscular Stretching in Temporomandibular Disorder Patients

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ClinicalTrials.gov Identifier: NCT02139735
Recruitment Status : Completed
First Posted : May 15, 2014
Last Update Posted : May 15, 2014
Sponsor:
Information provided by (Responsible Party):
Eliane Correa, Universidade Federal de Santa Maria

Brief Summary:
The combination of ultrasound and muscular stretching may have positive effects on pain relief and on the balance of the masticatory muscles activity.

Condition or disease Intervention/treatment Phase
Temporomandibular Joint Disorders Other: Ultrasound Other: Ultrasound associated with stretching Other: Placebo Not Applicable

Detailed Description:
This study aimed to evaluate the therapeutic response of ultrasound (US) and ultrasound associated with stretching of the masticatory muscles on the pressure pain threshold and the electrical activity of masseter and anterior temporal muscles in Temporomandibular Disorder (TMD) patients . The study included 18 women with TMD diagnosed by the instrument Research Diagnostic Criteria for Temporomandibular Disorders (RDC / TMD). The pressure pain threshold, evaluated through algometry, and the electrical activity of the masticatory muscles were evaluated, by means of surface electromyography, before and immediately after the therapeutic procedures. The volunteers underwent three different interventions: ultrasound, ultrasound associated with stretching and ultrasound placebo, with a 1-week of minimum interval between them.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Therapeutic Response of Ultrasound and Muscular Stretching in Temporomandibular Disorder Patients: Clinical Trial
Study Start Date : March 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ultrasound
3 MHz (Mega Hertz) ultrasound in continuous mode with an intensity of 1.0 W / cm ² was applied for 3 minutes in the TMJ (Temporomandibular joint) and masseter muscles bilaterally
Other: Ultrasound associated with stretching

3 MHz ultrasound in continuous mode with an intensity of 1.0 W / cm ² was applied for 3 minutes in the TMJ and masseter muscles, bilaterally.

Active stretching of the masseter muscles with mouth opening and closed lips


Other: Placebo
Turned off ultrasound application on area of TMJ and masseter muscle, bilaterally.

Experimental: Ultrasound associated with stretchting

3 MHz ultrasound in continuous mode with an intensity of 1.0 W / cm ² was applied for 3 minutes in the TMJ and masseter muscles bilaterally.

Active stretching of the masseter muscles with mouth opening and closed lips

Other: Ultrasound
3 MHz ultrasound in continuous mode with an intensity of 1.0 W / cm ² was applied for 3 minutes in the TMJ and masseter muscles bilaterally

Other: Placebo
Turned off ultrasound application on area of TMJ and masseter muscle, bilaterally.

Experimental: Placebo
Turned off ultrasound application on area of TMJ and masseter muscle, bilaterally.
Other: Ultrasound
3 MHz ultrasound in continuous mode with an intensity of 1.0 W / cm ² was applied for 3 minutes in the TMJ and masseter muscles bilaterally

Other: Ultrasound associated with stretching

3 MHz ultrasound in continuous mode with an intensity of 1.0 W / cm ² was applied for 3 minutes in the TMJ and masseter muscles, bilaterally.

Active stretching of the masseter muscles with mouth opening and closed lips





Primary Outcome Measures :
  1. pressure pain threshold [ Time Frame: 10 minutes ]
    algometry


Secondary Outcome Measures :
  1. surface electromyography [ Time Frame: 10 minutes ]
    electromyographic activity was measure at rest, in maximal intercuspal position and maximal voluntary clench



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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of myogenic or mixed TMD according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC / TMD)
  • women aged 20 to 35 years.

Exclusion Criteria:

  • psychomotor impairment ;
  • history of orthopedic trauma involving the temporomandibular region , orofacial surgery or poor training ;
  • analgesics , anti-inflammatories , muscle relaxants , antidepressants ;
  • presence of acute TMJ pain ( last 3 months) ;
  • have perform physical therapy or speech therapy for the past 6 months;
  • periods of the end of the menstrual cycle (7 days prior to menstruation ) and onset of menstruation ( first 2 days ) were excluded for conducting evaluations of volunteers who did not use oral contraception and those who used it to break.

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): NCT02139735


Locations
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Brazil
Universidade Federal de Santa Maria
Santa Maria, Rio Grande do Sul, Brazil, 97105-900
Sponsors and Collaborators
Universidade Federal de Santa Maria
Investigators
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Principal Investigator: Eliane C. Corrêa, Doctor Universidade Federal de Santa Maria
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Responsible Party: Eliane Correa, Doctor, Universidade Federal de Santa Maria
ClinicalTrials.gov Identifier: NCT02139735    
Other Study ID Numbers: UFSM-MO-01
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: May 15, 2014
Last Verified: May 2014
Keywords provided by Eliane Correa, Universidade Federal de Santa Maria:
Temporomandibular Joint Disorders,
Ultrasonics,
Electromyography,
Pain Measurement,
Muscle Stretching Exercise
Additional relevant MeSH terms:
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Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Joint Diseases
Disease
Pathologic Processes
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes