Therapeutic Response of Ultrasound and Muscular Stretching in Temporomandibular Disorder Patients

Temporomandibular Joint Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02139735
• Other study ID #: UFSM-MO-01
• Status: Completed
• Phase: N/A
• First received: May 9, 2014
• Last updated: May 13, 2014
• Start date: March 2012
• Est. completion date: March 2014

Study information

• Verified date: May 2014
• Source: Universidade Federal de Santa Maria
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Joint Diseases
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

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

Locations

Country	Name	City	State
Brazil	Universidade Federal de Santa Maria	Santa Maria	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Santa Maria

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pressure pain threshold	algometry	10 minutes	No
Secondary	surface electromyography	electromyographic activity was measure at rest, in maximal intercuspal position and maximal voluntary clench	10 minutes	No