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