Therapeutic Response of Ultrasound and Muscular Stretching in Temporomandibular Disorder Patients

May 13, 2014 updated by: Eliane Correa, Universidade Federal de Santa Maria

Therapeutic Response of Ultrasound and Muscular Stretching in Temporomandibular Disorder Patients: Clinical Trial

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Santa Maria, Rio Grande do Sul, Brazil, 97105-900
        • Universidade Federal de Santa Maria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 31 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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: 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
Experimental: Placebo
Turned off ultrasound application on area of TMJ and masseter muscle, 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: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
pressure pain threshold
Time Frame: 10 minutes
algometry
10 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
surface electromyography
Time Frame: 10 minutes
electromyographic activity was measure at rest, in maximal intercuspal position and maximal voluntary clench
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Federal de Santa Maria

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eliane C. Corrêa, Doctor, Universidade Federal de Santa Maria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UFSM-MO-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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