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

August 23, 2010
August 24, 2010
April 2007
August 2007   (final data collection date for primary outcome measure)
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.
Visual Analog Scale [ 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, in which the left end meant no pain, and the right end, the worst pain ever felt.
Complete list of historical versions of study NCT01187316 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Treatment of Temporomandibular Disorders
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Temporomandibular Joint Disorders
  • 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.
  • Other: Physiotherapy
    Massage and stretching of the anterior temporal and masseter muscle were performed by an experienced professional for 20 minutes.
  • Experimental: TENS
    Intervention: Device: Transcutaneous electrical nerve stimulation
  • Active Comparator: Massage therapy and muscle stretching
    Intervention: Other: Physiotherapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
September 2007
August 2007   (final data collection date for primary outcome measure)

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
Female
14 Years to 24 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01187316
1-R6YV8
No
Arnaldo de França Caldas Junior, University of Pernambuco
University of Pernambuco
Not Provided
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
University of Pernambuco
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP