Back to Trials
NCT05916235NARecruiting

Photobiomodulation for Management of Temporomandibular Disorder Pain

University of Florida

Start Date

2/8/2024

Completion Date

10/1/2028

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.

Eligibility Criteria

Age Range: 18 years to 99 years

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

Interventions

DEVICE

THOR® laser system

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Pain Related to TMD

Locations

University of Florida

Gainesville, Florida 32610

United States