A Double-blind, Placebo-controlled, Randomized Evaluation of the Effect of the Erchonia® EVRL on Chronic Jaw Pain Arising From TMJ Clinical Study Protocol
Erchonia Corporation
Summary
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
- Age range
- 22–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. * Subjects score ≥3 points on the validated TMD Pain Screener (long version). * Subject has a primary diagnosis of TMJ-related nociceptive musculoskeletal pain made by a suitably qualified healthcare professional, confirmed using the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I, w…
Interventions
- DeviceErchonia® EVRL™
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.
- DevicePlacebo Device
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.
Location
- Acton Dental AssociatesActon, Massachusetts