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Effect of Phototherapy in Individuals With Temporomandibular Disorder.

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2014 by University of Nove de Julho.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Daniela Ap. Biasotto-Gonzalez, University of Nove de Julho Identifier:
First received: December 17, 2013
Last updated: March 10, 2014
Last verified: January 2014
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%.

Condition Intervention Phase
Temporomandibular Disorder.
Radiation: Phototherapy
Radiation: Placebo phototherapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Phototherapy on Pain, Muscles Activity and Joint Mobility in Individuals With Temporomandibular Disorder: A Randomized, Placebo-Controlled and Double-Blind Clinical Trial.

Resource links provided by NLM:

Further study details as provided by University of Nove de Julho:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Electromyographic activity [ Time Frame: 1 year ]
    The electrical powers of masticatory muscles will be verified in this study through surface electromyography, specifically the masseter and temporal muscles, serving as a useful tool to quantify muscle activity during Mastication and thus identify its functional changes.

Other Outcome Measures:
  • Analysis of superficial cutaneous temperature [ Time Frame: 1 year ]
    A thermal camera model FLIR T450 ® SC Systems (Stockholm, Sweden) is used to measure the surface skin temperature of the masseter and temporal muscles to verify the effect of phototherapy in them.

Estimated Enrollment: 48
Study Start Date: January 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phototherapy
Three groups will receive different fototerapia of light sources, and group 1 will not receive dose: Group A (0, 65Joules), Group B (1.30 Joules) and Group C (1.95 Joules) .
Radiation: Phototherapy
Portable Cluster 9 PainAway ® diodes manufactured by Multi Radiance Medical ® (Solon, OH-USA), being 1 905 nm diode (1 mW average power 10 W of peak power, spot of 0.44 cm2), 875 nm diodes 4 (17.5 mW average power for each diode, spot of 1 cm2) and 670 nm diodes 4 (15 mW average power for each diode1 spot, cm2), frequency of 1000 Hz, irradiation time of 300 seconds, energy delivered from 39.3 Joules.
Placebo Comparator: Placebo phototherapy
The volunteers will be subjected to the same Groups intervention Phototherapy . The but researcher will receive placebo pen. It is the caveat that, after completed the voluntary participation, will be held with the active pen treatment.
Radiation: Placebo phototherapy
The volunteers will be subjected to the same Groups ' intervention and placebo pen Phototherapy.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT02018770

University of Nove de Julho Recruiting
Sao Paulo, São Paulo, Brazil, 01415000
Contact: Daniela Ap Biasotto-Gonzalez, Doctor    +5511999063166   
Sponsors and Collaborators
University of Nove de Julho
Principal Investigator: Daniela Ap Biasotto-Gonzalez, Doctor University of Nove de Julho
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Daniela Ap. Biasotto-Gonzalez, Doctor, University of Nove de Julho Identifier: NCT02018770     History of Changes
Other Study ID Numbers: 18032013.4.0000.5511
Study First Received: December 17, 2013
Last Updated: March 10, 2014

Keywords provided by University of Nove de Julho:
Temporomandibular Disorders, Electromyogram,
Modalities of physiotherapy,
Temporomandibular dysfunction syndrome,

Additional relevant MeSH terms:
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Pathologic Processes
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes processed this record on April 28, 2017