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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
14
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.
sham THOR® laser system
University of Florida
Gainesville, Florida, United States
Pain Level Change With PBM Treatment Using a Numerical Rating Scale 0=no Pain and 100=the Most Intense Pain Imaginable
Using a numerical rating scale (NRS) requires the patient to rate their pain on a defined scale 0=no pain and 100=the most intense pain imaginable to rate the average daily pain from Daily Pain \& Symptom Dairy over one week prior to V1 will be compared to the average daily pain one week prior to V8.
Time frame: Through study completion; an average of 10 weeks
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