Effect of Phototherapy in Individuals With Temporomandibular Disorder.

Phase 1

• Conditions: Temporomandibular Disorder.
• Interventions: Radiation: Phototherapy; Radiation: Placebo phototherapy

• Registration Number: NCT02018770
• Lead Sponsor: University of Nove de Julho

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%.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-17
• Study First Submitted QC: 2013-12-20
• Study First Posted: 2013-12-23
• Status Verified: 2014-01
• Study Start: 2014-01
• Last Update Submitted: 2014-03-10
• Last Update Posted: 2014-03-11
• Primary Completion: 2014-09
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phototherapy	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) .
Placebo phototherapy	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.

Primary Outcome Measures

Name	Time	Method
Pain intensity.	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

Name	Time	Method
Electromyographic activity	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.

Trial Locations

Locations (1)

University of Nove de Julho; 🇧🇷 Sao Paulo, São Paulo, Brazil