Photobiomodulation for Management of Temporomandibular Disorder Pain

Eligibility Criteria

• * Male or female, aged 18 years and older
• * Meets the CATI pre-screening criteria during pre-screening visit \[participant-reported facial pain for at least 3 months and an average pain intensity rating for the week preceding CATI of ≥30 on a numerical rating scale (NRS, 0-100)\].
• * Willing to provide signed and dated informed consent
• * Willing to to comply with all study procedures and to be available for the duration of the study
• * Meets diagnostic criteria for TMD (Masticatory Muscle disorder, 1 A: Myalgia) during Visit 0
• * Completes a minimum of 4 of 7 daily symptom diary (DSD) entries prior to Visit 1 (Randomization visit), and the weekly average pain score on this DSD is ≥30 of 100
• * Active rheumatologic disease
• * Has a medical condition, laboratory finding, or physical exam finding (e.g., renal failure or dialysis, uncontrolled diabetes mellitus, hyperthyroidism, fibromyalgia, or uncontrolled seizures) that precludes participation as determined by the investigator
• * Initiated occlusal appliance therapy within 30 days prior to CATI
• * Initiated non-pharmacologic therapy, such as acupuncture, biofeedback, and/or TENS within 30 days prior to CATI
• * Is in active orthodontic treatment
• * Received any injection therapy (e.g., tender or trigger point injections, steroid injections) for the management of pain within 14 days prior to the CATI
• * Has a history of facial trauma or orofacial surgery within 6 weeks prior to CATI
• * Has a history of psychiatric hospitalization within one year prior to CATI
• * Currently pregnant or lactating
• * Has a known hypersensitivity to laser therapy
• * Currently being treated with chemotherapy or radiation therapy
• * Is undergoing treatment with another investigational drug or treatment initiated within 30 days prior to the Screening and Baseline Visit
• * Initiated a new daily prescribed or over-the counter medication for the management of pain within 30 days prior to Screening and Baseline Visit.
• * Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study as determined by the investigator