We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Temporomandibular Disorders

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01187316
First Posted: August 24, 2010
Last Update Posted: August 25, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Pernambuco
  Purpose
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.

Condition Intervention
Temporomandibular Joint Disorders Device: Transcutaneous electrical nerve stimulation Other: Physiotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Massage and Transcutaneous Electrical Nerve Stimulation Therapies for Temporomandibular Disorders in Adolescents

Resource links provided by NLM:


Further study details as provided by University of Pernambuco:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 8
Study Start Date: April 2007
Study Completion Date: September 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   14 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01187316


Locations
Brazil
Faculty of Dentistry of Pernambuco; Orofacial Control Center
Camaragibe, Pernambuco, Brazil
Faculty of Dentistry of Pernambuco; Orofacial Control Center
Recife, Pernambuco, Brazil
Sponsors and Collaborators
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
  More Information

Publications:
Responsible Party: Arnaldo de França Caldas Junior, University of Pernambuco
ClinicalTrials.gov Identifier: NCT01187316     History of Changes
Other Study ID Numbers: 1-R6YV8
First Submitted: August 23, 2010
First Posted: August 24, 2010
Last Update Posted: August 25, 2010
Last Verified: March 2007

Keywords provided by University of Pernambuco:
Facial Pain
Temporomandibular Joint Disorders
Transcutaneous Electric Nerve Stimulation
Adolescent

Additional relevant MeSH terms:
Disease
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Joint Diseases
Pathologic Processes
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes