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Therapeutic Response of Ultrasound and Muscular Stretching in Temporomandibular Disorder Patients

Primary Purpose

Temporomandibular Joint Disorders

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Ultrasound
Ultrasound associated with stretching
Placebo
Sponsored by
Universidade Federal de Santa Maria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Disorders focused on measuring Temporomandibular Joint Disorders,, Ultrasonics,, Electromyography,, Pain Measurement,, Muscle Stretching Exercise

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidade Federal de Santa Maria

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Ultrasound

Ultrasound associated with stretchting

Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

pressure pain threshold
algometry

Secondary Outcome Measures

surface electromyography
electromyographic activity was measure at rest, in maximal intercuspal position and maximal voluntary clench

Full Information

First Posted
May 9, 2014
Last Updated
May 13, 2014
Sponsor
Universidade Federal de Santa Maria
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1. Study Identification

Unique Protocol Identification Number
NCT02139735
Brief Title
Therapeutic Response of Ultrasound and Muscular Stretching in Temporomandibular Disorder Patients
Official Title
Therapeutic Response of Ultrasound and Muscular Stretching in Temporomandibular Disorder Patients: Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Santa Maria

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders
Keywords
Temporomandibular Joint Disorders,, Ultrasonics,, Electromyography,, Pain Measurement,, Muscle Stretching Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound
Arm Type
Experimental
Arm Description
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
Arm Title
Ultrasound associated with stretchting
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Turned off ultrasound application on area of TMJ and masseter muscle, bilaterally.
Intervention Type
Other
Intervention Name(s)
Ultrasound
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Ultrasound associated with stretching
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Turned off ultrasound application on area of TMJ and masseter muscle, bilaterally.
Primary Outcome Measure Information:
Title
pressure pain threshold
Description
algometry
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
surface electromyography
Description
electromyographic activity was measure at rest, in maximal intercuspal position and maximal voluntary clench
Time Frame
10 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eliane C. Corrêa, Doctor
Organizational Affiliation
Universidade Federal de Santa Maria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal de Santa Maria
City
Santa Maria
State/Province
Rio Grande do Sul
ZIP/Postal Code
97105-900
Country
Brazil

12. IPD Sharing Statement

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Therapeutic Response of Ultrasound and Muscular Stretching in Temporomandibular Disorder Patients

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