Effect of Phototherapy in Individuals With Temporomandibular Disorder.

Study 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%.

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.

Conditions
-----------------
Temporomandibular Disorder.

Intervention / Treatment
-----------------
* Radiation: Phototherapy
* Radiation: Placebo phototherapy


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phototherapy<br>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<br>* 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.<br>|
| Placebo Comparator: Placebo phototherapy<br>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<br>* The volunteers will be subjected to the same Groups ' intervention and placebo pen Phototherapy.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity. | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electromyographic activity | 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. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Temporomandibular Disorders, Electromyogram,, Modalities of physiotherapy,, Temporomandibular dysfunction syndrome,, Lasers.