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Clinical Trials/NCT02018770
NCT02018770
Unknown
Phase 1

Effect of Phototherapy on Pain, Muscles Activity and Joint Mobility in Individuals With Temporomandibular Disorder: A Randomized, Placebo-Controlled and Double-Blind Clinical Trial.

University of Nove de Julho1 site in 1 country48 target enrollmentJanuary 2014

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Temporomandibular Disorder.
Sponsor
University of Nove de Julho
Enrollment
48
Locations
1
Primary Endpoint
Pain intensity.
Last Updated
12 years ago

Overview

Brief Summary

The present study aims to evaluate the effect of phototherapy with the combination of different sources of light on pain, activity of temporal and masseter muscles, bilateral and joint mobility in subjects with TMD. It will be made a randomized, placebo-controlled and double-blind clinical trial. Individuals participate with myogenic temporomandibular disorder, being allocated into 4 groups randomly and stratified by the method of sealed envelopes. The results will be evaluated using: RDC/TMD, digital caliper, electromyography, and visual analog scale and algometry. The protocols will be used in a single session and will be evaluated in four different moments. The variables that will be investigated are pain, muscle activity and joint mobility. The analyses of the data will be performed by adopting a significance level of 5%.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
December 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Daniela Ap. Biasotto-Gonzalez

Doctor

University of Nove de Julho

Eligibility Criteria

Inclusion Criteria

  • 18 to 40 years.
  • Female volunteers.
  • Diagnosis of myogenic TMD pain must masseter presenting moderate to severe according to the RDC / TMD.
  • Display body mass index (BMI) less than 25 kg/m2 to standardize the sample.
  • In addition, volunteers must submit scores of pain greater than 3 cm according to the Visual Analog Scale masticatory muscles.

Exclusion Criteria

  • history of neurological disorders.
  • chronic neck pain resulting from a traumatic incident.
  • chronic musculoskeletal condition.
  • medical diagnosis of fibromyalgia; systemic disease.
  • connective tissue disorder.
  • having undergone physical therapy use of analgesic, muscle relaxant.

Outcomes

Primary Outcomes

Pain intensity.

Time Frame: 1 year

Will be used a algometry D-200 of Instrutherm ®, which is a semi quantitative method to measure the intensity of the pain by the pressure, find painful spots, in addition to quantify changes the various pain syndromes.

Secondary Outcomes

  • Electromyographic activity(1 year)

Study Sites (1)

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