Effect of Phototherapy in Individuals With Temporomandibular Disorder.

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Nove de Julho
Sponsor:
Information provided by (Responsible Party):
Daniela Ap. Biasotto-Gonzalez, University of Nove de Julho
ClinicalTrials.gov Identifier:
NCT02018770
First received: December 17, 2013
Last updated: March 10, 2014
Last verified: January 2014
  Purpose

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 (Subject, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  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: NCT02018770

Locations
Brazil
University of Nove de Julho Recruiting
Sao Paulo, São Paulo, Brazil, 01415000
Contact: Daniela Ap Biasotto-Gonzalez, Doctor    +5511999063166    dani_atm@ig.com.br   
Sponsors and Collaborators
University of Nove de Julho
Investigators
Principal Investigator: Daniela Ap Biasotto-Gonzalez, Doctor University of Nove de Julho
  More Information

Additional Information:
No publications provided

Responsible Party: Daniela Ap. Biasotto-Gonzalez, Doctor, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT02018770     History of Changes
Other Study ID Numbers: 18032013.4.0000.5511
Study First Received: December 17, 2013
Last Updated: March 10, 2014
Health Authority: Brazil: National Committee of Ethics in Research

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

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

ClinicalTrials.gov processed this record on September 18, 2014