NCT02139735

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 15, 2014

Completed
Last Updated

May 15, 2014

Status Verified

May 1, 2014

Enrollment Period

1.3 years

First QC Date

May 9, 2014

Last Update Submit

May 13, 2014

Conditions

Keywords

Temporomandibular Joint Disorders,Ultrasonics,Electromyography,Pain Measurement,Muscle Stretching Exercise

Outcome Measures

Primary Outcomes (1)

  • pressure pain threshold

    algometry

    10 minutes

Secondary Outcomes (1)

  • surface electromyography

    10 minutes

Study Arms (3)

Ultrasound

EXPERIMENTAL

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 stretchingOther: Placebo

Ultrasound associated with stretchting

EXPERIMENTAL

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: UltrasoundOther: Placebo

Placebo

EXPERIMENTAL

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

Other: UltrasoundOther: Ultrasound associated with stretching

Interventions

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

PlaceboUltrasound 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

PlaceboUltrasound
PlaceboOTHER

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

UltrasoundUltrasound associated with stretchting

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de Santa Maria

Santa Maria, Rio Grande do Sul, 97105-900, Brazil

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Eliane C. Corrêa, Doctor

    Universidade Federal de Santa Maria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

May 9, 2014

First Posted

May 15, 2014

Study Start

March 1, 2012

Primary Completion

June 1, 2013

Study Completion

March 1, 2014

Last Updated

May 15, 2014

Record last verified: 2014-05

Locations