Photobiomodulation for the Management of Temporomandibular Disorder Pain

Photobiomodulation for the Management of Temporomandibular Disorder Pain

Photobiomodulation (PBM), is FDA-approved for temporary relief of muscle and joint pain, but there is no indication for TMD. Our goal in this study is to conduct a clinical trial of multimodal PBM for TMD pain. Also, we propose to determine if PBM-induced changes in inflammation contribute to PBM's analgesic effects. This study will be a double-blind, sham-controlled, randomized trial testing the efficacy of PBM for pain related to TMD.

Inclusion Criteria:

• Provides a signed and dated informed consent form
• Is at least 18 years of age (male or female and any race or ethnicity)
• Meets diagnostic criteria for TMD, ( Masticatory Muscle Disorders, 1A: Myalgia)
• Has experienced facial pain for at least 3 months
• At Screening and Baseline Visit (Visit 0), reports an average pain intensity rating over the past week of ≥ 30 on a numerical rating scale (0-100)

Exclusion Criteria:

• Starting a new daily prescription medication for the management of pain within 30 days prior to treatment session;
• Use of any injection therapy (e.g., tender or trigger point injections, steroid injections) for the management of pain within 2 weeks prior to the CATI;
• Starting occlusal appliance therapy within 30 days prior to CATI; d) history of facial trauma or orofacial surgery within 6 weeks prior to CATI;
• Active orthodontic treatment;
• Psychiatric hospitalization within one year prior to screening.
• Has known hypersensitivity to laser therapy.
• Currently being treated with chemotherapy or radiation therapy
• Has been treated with another investigational drug or treatment within 30 days prior to the Screening and Baseline Visit
• Is pregnant or nursing
• Anything that, in the opinion of the investigator, would place the participant at increased risk or preclude the participant's full compliance with or completion of the study