Photobiomodulation for the management of Temporomandibular disorder pain - Project Summary/Abstract Given the paucity of effective treatments for TMD and the overuse of pain medication, well-designed studies are needed to evaluate non-pharmacological alternatives to treat this common and disabling chronic pain condition. Our goal in this study is to conduct a double-blind, sham-controlled, randomized clinical trial of multimodal Photobiomodulation (PBM) for TMD pain. Also, we propose to determine if PBM-induced changes in inflammation and pain sensitivity contribute to PBM’s analgesic effects. A total of 130 TMD participants will be recruited through community-based advertisements. Participants will complete a computer-assisted telephone screening (CATI). Eligible participants will be age 18 and older with pain intensity of ≥30 on a visual analog scale (0-100). Participants will be excluded if: a) starting a new daily prescription medication for the management of pain within 30 days before CATI; b) use of injection therapy (e.g., tender or trigger point injections, steroid injections) for the management of pain within 2 weeks before the CATI; c) starting occlusal appliance therapy within 30 days before CATI; d) history of facial trauma or orofacial surgery within 6 weeks before CATI; e) active orthodontic treatment; f), psychiatric hospitalization within one year before the screening. Participants eligible after CATI will be scheduled for a pre-randomization visit (V0), eight treatment visits (V1 to V8), one post- treatment visit (V9), an internet/ phone follow-up at 1 and 3 months, and six-month follow-up clinical visit (V10). V0 will include informed consent, completion of a detailed medical history and to assess clinical pain and interference, participants will complete the Pain, Enjoyment, General Activity (PEG) Scale followed by a clinical exam to confirm TMD status according to the Diagnostic Criteria for TMD (DC/TMD), Pressure Pain Sensitivity (PPT) and blood draw. V1 will be the randomization visit to either receive PBM or Placebo. V2-V8 are treatment visits. V5 is also the Midway visit, therefore, a blood draw, DC/TMD exam and PPT will be performed before treatment. At V9 (post-treatment visit), post-treatment outcomes will be assessed, PEG, DC/TMD exam, PPT and a blood draw. PBM/Placebo treatment: We will use three types of active/Placebo probes; A) Single Laser 808 nm, 4.75W/cm 2; B) Laser Cluster, five x 810 nm, 5.96W/cm 2 and four LED 660nm, 0.05W/cm 2and; C) LED Cluster, 56 X 660nm 0.51W/cm2 and 48 850nm, 0.45W/cm2, 950mW total applied to multiple craniofacial sites. Analyses will determine treatment effects on the primary outcome (pain intensity) and multiple secondary outcomes and will examine, exploratorily, whether changes in inflammation and pain sensitivity mediate treatment response. Findings from this rigorously designed trial will provide the most definitive evidence to date regarding the effectiveness and mechanisms of PBM for treating TMD pain.
