Treatment of Temporomandibular Disorders

August 24, 2010 updated by: University of Pernambuco

Massage and Transcutaneous Electrical Nerve Stimulation Therapies for Temporomandibular Disorders in Adolescents

The aim of the present study was to carry out a pilot project comparing the effectiveness of two therapeutic approaches to temporomandibular disorders (TMDs) in adolescents. Eight female individuals diagnosed based on the Research Diagnosis Criteria for TMDs (RDC/TMD-axis 1)were randomly divided into two groups: 1) Massage therapy and muscle stretching (n=4); and 2) transcutaneous electrical nerve stimulation (TENS) (n=4). Regardless the treatment, ten sessions were held for each patient and two measurements (baseline and 10th session) were performed for the assessment of symptom evolution using a visual analog scale (VAS), maximum opening of the mouth (MOM) and pressure pain threshold (PPT). Statistical analysis wiil be carefully selected.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • 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
    • Pernambuco
      • Camaragibe, Pernambuco, Brazil
        • Faculty of Dentistry of Pernambuco; Orofacial Control Center
      • Recife, Pernambuco, Brazil
        • Faculty of Dentistry of Pernambuco; Orofacial Control Center

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

Ages Eligible for Study

14 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pain in orofacial area for at least 3 months
  • Diagnosed at group 1 of RDC/TMD (myofascial pain with or without mouth opening limit)

Exclusion Criteria:

  • Drug use for treatment of pain
  • Functional limitations that would harm diagnosis

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TENS
Device: Transcutaneous electrical nerve stimulation
Sensors were positioned on anterior temporal and masseter muscles bilaterally, and the stimulation was used for 20 minutes at 150 Hz and 100 µs of pulse width; intensity was adjusted individually.
Active Comparator: Massage therapy and muscle stretching
Other: Physiotherapy
Massage and stretching of the anterior temporal and masseter muscle were performed by an experienced professional for 20 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: Two times a week
The subjects was asked to mark the intensity of the pain on a 100mm line, which was numbered from 0 to 10, being "0" = no pain, and 10 = to the worst pain ever felt. The outcome of pain intensity was given as a number marked by the patient.
Two times a week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum mouth opening amplitude
Time Frame: Two times a week
Subjects were asked to open their mouths as much as they could and the opening amplitude was measured using a digital caliper.
Two times a week

Collaborators and Investigators

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

Sponsor

University of Pernambuco

Investigators

  • Principal Investigator: Arnaldo F Caldas Junior, PhD, University of Pernambuco
  • Study Director: Silvia D Benevides, Ms, Federal University of Bahia
  • Study Chair: Mauricio Kosminsky, PhD, University of Pernambuco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2007

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

August 23, 2010

First Submitted That Met QC Criteria

August 23, 2010

First Posted (Estimate)

August 24, 2010

Study Record Updates

Last Update Posted (Estimate)

August 25, 2010

Last Update Submitted That Met QC Criteria

August 24, 2010

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-R6YV8

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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