The purpose of this clinical study is to determine the effectiveness of the Erchonia EVRL, manufactured by Erchonia Corporation (the Company), in providing temporary relief of nociceptive musculoskeletal chronic jaw pain arising from temporomandibular joint (TMJ).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
64
The Erchonia® EVRL™ is a handheld device containing one 635 nm red laser diode and one 405 nm violet laser diode. During treatment, the diodes are positioned approximately 3 to 4 inches from the skin over the temporomandibular joint area. Treatment is administered for a total of 16 minutes, with 8 minutes applied to each side.
The Placebo Laser has the same appearance as the Erchonia® EVRL™ but does not emit any therapeutic light. During treatment, the diodes are positioned approximately 3 to 4 inches from the skin over the temporomandibular joint area. Treatment is administered for a total of 16 minutes, with 8 minutes applied to each side.
Acton Dental Associates
Acton, Massachusetts, United States
RECRUITINGNumber of Participants With a 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) from baseline to endpoint (immediately after treatment) measurement is calculated for each subject. Individual subject success is defined as a 30% or greater change in VAS pain scores across the evaluation period. A negative (-) percent change indicates a decrease in pain level and is positive for individual subject success. A lower Visual Analog Scale pain score from baseline to study endpoint represents a better outcome, whereas a higher score from baseline to study endpoint represents a worse outcome. For the primary study outcome, the overall study success is defined as a 35% or greater difference between the proportion (number) of individual successes in each treatment group.
Time frame: Baseline and immediately after treatment
Change in Mouth Opening Measurements
Mouth opening measurements will be obtained as part of the Diagnostic Criteria for Temporomandibular Disorders clinical examination. The following measurements will be recorded in millimeters for each subject: pain-free opening, maximum unassisted opening, and maximum assisted opening. Measurements collected at the study qualification visit will serve as baseline values. The same measurements will be repeated immediately after treatment. The change from baseline to immediately after treatment will be calculated for each measurement. An increase in mouth opening measurement from baseline to endpoint represents improved mandibular range of motion.
Time frame: Baseline and immediately after treatment
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