About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Able to understand and voluntarily sign the IRB-approved informed consent form.
Adults 22 to 75 years of age.
Subject's self-reported rating for jaw pain on the 0-100 VAS pain scale is 50 or greater (≥ 50).
Constant jaw pain on-going over at least the past 3 months.
Disqualifiers
Pain that is undiagnosed or determined by a qualified medical/dental professional to be primarily attributable to causes other than TMJ-related nociceptive musculoskeletal pain.
Diagnosis using the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I does not include at least one of the following pain-related diagnoses: myalgia (including local myalgia, myofascial pain, myofascial pain with spreading, myofascial pain with referral) and/or arthralgia OR includes one or more of the following pain-related diagnoses: disc displacement disorder with reduction, disc replacement disorder with reduction with intermittent locking, disc displacement disorder without reduction with limited opening, disc displacement disorder without reduction without limited opening, degenerative joint disease, headache attributed to RMD, and subluxation.
History of surgical intervention involving the temporomandibular joint within the past 12 months, or any history of total joint replacement or major reconstructive surgery of the TMJ.
Intra-articular TMJ interventions, including corticosteroid injections, botulinum toxin injections, or prolotherapy, within 3 months prior to enrollment.
Trial design
Parallel
Treatments tested in this trial
Erchonia® EVRL™
DeviceThe 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.
Placebo Device
DeviceThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Number 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.
Secondary outcomes
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.
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