Effect of Phototherapy in Individuals With Temporomandibular Disorder.

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

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%.

Study Overview

• Status: Unknown
• Conditions: Temporomandibular Disorder.
• Intervention / Treatment: Radiation: Phototherapy; Radiation: Placebo phototherapy

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Sao Paulo, São Paulo, Brazil, 01415000
      • Recruiting
      • University of Nove de Julho
      • Contact: Daniela Ap Biasotto-Gonzalez, Doctor; Phone Number: +5511999063166; Email: dani_atm@ig.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of superficial cutaneous temperature	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.	1 year

Collaborators and Investigators

• Sponsor: University of Nove de Julho
• Investigators: Principal Investigator: Daniela Ap Biasotto-Gonzalez, Doctor, University of Nove de Julho

Publications and helpful links

General Publications

• Herpich CM, Leal-Junior ECP, Gomes CAFP, Gloria IPDS, Amaral AP, Amaral MFRS, Politti F, Biasotto-Gonzalez DA. Immediate and short-term effects of phototherapy on pain, muscle activity, and joint mobility in women with temporomandibular disorder: a randomized, double-blind, placebo-controlled, clinical trial. Disabil Rehabil. 2018 Sep;40(19):2318-2324. doi: 10.1080/09638288.2017.1336648. Epub 2017 Jun 11.
• Herpich CM, Leal-Junior EC, Amaral AP, Tosato Jde P, Gloria IP, Garcia MB, Barbosa BR, El Hage Y, Arruda EE, Gomes CA, Rodrigues MS, de Sousa DF, de Carvalho Pde T, Bussadori SK, Gonzalez Tde O, Politti F, Biasotto-Gonzalez DA. Effects of phototherapy on muscle activity and pain in individuals with temporomandibular disorder: a study protocol for a randomized controlled trial. Trials. 2014 Dec 16;15:491. doi: 10.1186/1745-6215-15-491.

Helpful Links

• URL of the University of Nove de Julho

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (ANTICIPATED): September 1, 2014
• Study Completion (ANTICIPATED): December 1, 2014

Study Registration Dates

• First Submitted: December 17, 2013
• First Submitted That Met QC Criteria: December 20, 2013
• First Posted (ESTIMATE): December 23, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): March 11, 2014
• Last Update Submitted That Met QC Criteria: March 10, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Temporomandibular Disorders, Electromyogram,; Modalities of physiotherapy,; Temporomandibular dysfunction syndrome,; Lasers.
• Additional Relevant MeSH Terms: Pathologic Processes; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Disease; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
• Other Study ID Numbers: 18032013.4.0000.5511