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Treatment of Temporomandibular Disorders

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ClinicalTrials.gov Identifier: NCT01187316
Recruitment Status : Completed
First Posted : August 24, 2010
Last Update Posted : August 25, 2010
Information provided by:
University of Pernambuco

Brief Summary:
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 or disease Intervention/treatment Phase
Temporomandibular Joint Disorders Device: Transcutaneous electrical nerve stimulation Other: Physiotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
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
Study Start Date : April 2007
Actual Primary Completion Date : August 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. 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 :
  1. 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.

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

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

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

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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
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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
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Responsible Party: Arnaldo de França Caldas Junior, University of Pernambuco
ClinicalTrials.gov Identifier: NCT01187316    
Other Study ID Numbers: 1-R6YV8
First Posted: August 24, 2010    Key Record Dates
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
Additional relevant MeSH terms:
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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