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
Qualifiers
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
Treatments tested in this trial
- Erchonia® EVRL™
- Placebo Device