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RECRUITING

NCT05916235

Photobiomodulation for Management of Temporomandibular Disorder Pain

Sponsor: University of Florida

View on ClinicalTrials.gov

Summary

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. This study will be a double-blind, sham-controlled, randomized trial testing the efficacy of PBM for pain related to TMD.

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2024-02-08

Completion Date

2028-10

Last Updated

2025-10-24

Healthy Volunteers

Conditions

Pain Related to TMD

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.

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, 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

Locations (1)

University of Florida

Gainesville, Florida, United States