Photobiomodulation In the Masseter and Temporal In Patients With Temporomandibular Joint Dysfunction

NCT03005730 | Completed DMC

• 1 other identifier: PHOTOBIOMODULATION DTM EXT.
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: According to the International Association for the Study of Pain (IASP), the term temporomandibular disorder (TMD) regards a subgroup of orofacial pain, the symptoms of which include pain or discomfort in the temporomandibular joint, ears, masticatory muscles and neck on one or both sides as well as joint sounds, limited mandibular movements or mandibular deviation and difficulties chewing. Phototherapy, such as low level laser therapy (LLLT) and light-emitting diode (LED) therapy, is one of the resources used to treatment muscle pain. Thus, there is a need to investigate therapeutic resources that combine different wavelengths as well as different light sources (LLLT and LED) in the same apparatus. Question: The aim of the proposed study is to evaluate the effects of phototherapy on pain, activity of the masticatory muscles (masseter and anterior temporal bilaterally) and joint mobility in individuals with temporomandibular disorder (TMD). A further aim is to determine the cumulative effect 24 and 48 hours after a six session. Methods/Design: A placebo-controlled, double-blind, randomized, clinical trial will be carried out involving 30 women between 18 and 40 years of age with a diagnosis of myogenous TMD. The participants will then be randomly allocated to two groups totaling 15 individuals per group. Group 1 submitted to a session of phototherapy with 39,27 Joules per point one group will receive placebo therapy (0 Joules). The following assessment tools will be administered on four separate occasions (baseline and immediately after, 24 h after and 48 h after phototherapy). Pain intensity will be assessed using the visual analog scale for pain, meter for range of movement, and electromyographic EMG analysis on the masseter and anterior temporal muscles. Discussion: The study will support the practice of evidence-based to the use of phototherapy in individuals with a myogenous TMD. Data will be published after the study is completed.

Conditions

Temporomandibular Disorder

Outcome Measures

Primary Outcomes (1)

• Visual analog scale

  A Visual analog scale allows the quantification of pain intensity. This scale consists of a straight line measuring 10 cm in length, with "absence of pain" written at one end and "worst pain ever felt" written at the other end. The volunteer will be instructed to make a perpendicular line between the two extremes that represents the pain level he/she is feeling at the time

  5 min

Secondary Outcomes (1)

• Range of motion

  10 min

Study Arms (2)

Group 1

EXPERIMENTAL

Submitted to a session of phototherapy with 39,27 Joules per point in muscle masseter and temporal bilateral.

Other: phototherapy

Group 2

PLACEBO COMPARATOR

Submitted to a session of phototherapy placebo with 0,0 Joules per point in muscle masseter and temporal bilateral.

Other: phototherapy placebo

Interventions

phototherapy OTHER

The portable PainAway® nine-diode cluster (Multi Radiance Medical®, Solon, OH, USA) will be employed. This system has one 905 nm laser diode, four 875 nm LED diodes and four 670 nm LED diodes. The aperture size of device is 4 cm2.

Group 1

phototherapy placebo OTHER

The placebo portable. The aperture size of device is 4 cm2 .

Group 2

Eligibility Criteria

• Age: 1 Year - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All volunteers will have a diagnosis of myogenous TMD based on the RDC/TMD with moderate to severe pain in the masseter and temporal muscles rated by an expert dentist. To standardize the sample, the body mass index of all participants must be less than 25 kg/m2, as the amount of adipose tissue between the electrode and surface of the muscle can affect that reading of the electromyographic (EMG) signal. All volunteers must also have an initial pain score greater than 3 points on the VAS.

Sponsors & Collaborators

• University of Nove de Julho: lead

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 26, 2016
• First Posted: December 29, 2016
• Study Start: December 10, 2016
• Primary Completion: May 10, 2017
• Study Completion: January 20, 2018
• Last Updated: January 26, 2018

Record last verified: 2018-01