Clinical Trial Finder

Inclusion 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.

Exclusion Criteria:

• - 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

Arms

Experimental: Experimental: Active PBM

PBM has been used clinically in the treatment of musculoskeletal and other pain conditions for over 30 years. Despite the low quality of the existing evidence, PBM has been increasingly used in other countries for the treatment of TMD. However, in the US PBM is not widely used for the treatment of TMD pain. Due to the multifactorial nature of chronic TMD pain, we propose that a multimodal PBM protocol targeting multiple pathophysiological mechanisms will be the optimal approach for PBM implementation in patients with TMD.

Sham Comparator: Sham PBM

When applying PBM therapy, there are some heating elements in the treatment device, and most of the sham treatment devices available do not offer this feature, which increases the likelihood of unblinding both the patient and the interventionist. The THOR® LX2.3 PBM machine includes this new feature, such that the sham condition mimics the heating activity of the active treatment.

Interventions

Device: - THOR® laser system

We chose the THOR® laser system given because their active treatment arm uses both coherent laser and monochromatic LED light. Therefore, we will use three types of active probes in this investigation including, A) Single Laser 810 NM 200 mw; B) Laser Cluster of 810 NM equivalent to 1 WATT and; C) LED Cluster, 34 X 660nm at 10 mw and 35 850nm, 30mw 1390mw total. As detailed in Table 3. We propose to use these three PBM probes in concert for the treatment of TMD pain. Laser A (Single Diode Laser) is designed for isolated trigger points and superficial muscles. Laser B (Cluster Laser) is designed for a more diffuse treatment area,targeting analgesia, anti-inflammatory, and deep tissue repair. Laser C (LED Cluster) is purportedly designed for the presence of diffuse inflammation.