Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Treatment of Temporomandibular Disorders

This study has been completed.
Sponsor:
Information provided by:
University of Pernambuco
ClinicalTrials.gov Identifier:
NCT01187316
First received: August 23, 2010
Last updated: August 24, 2010
Last verified: March 2007
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   14 Years to 24 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: August 23, 2010
Last Updated: August 24, 2010
Health Authority: Brazil: Ethics Committee

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

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

ClinicalTrials.gov processed this record on November 25, 2014