A protocol for a randomized controlled trial of photobiomodulation for management of temporomandibular disorder pain in Adults

Evidence-based treatments for painful temporomandibular disorders (TMD) are lacking. The most common treatments for painful TMDs, intraoral appliances and pain medication, provide suboptimal pain control, often leading to treatment-limiting adverse effects. Photobiomodulation therapy (PBM) shows substantial potential for the management of pain in people with a TMD; however, its efficacy for TMD pain reduction has not been rigorously tested. We will conduct a double-blind, randomized, placebo-controlled clinical trial of multimodal PBM for TMD pain. This single-site trial will randomize 130 participants, aged 18 years and older, with chronic painful TMD. Individuals will complete a detailed medical history to confirm eligibility criteria, followed by a clinical exam to confirm TMD case status according to the Diagnostic Criteria for TMD (DC/TMD). Eligible participants will be randomized to either active or sham PBM treatment. Participants will complete eight treatment visits scheduled 2–5 days apart. This will be followed by a post-intervention visit that will include symptom questionnaires, TMD exam, pressure pain threshold (PPT) measures, and blood draw. A 6-month follow-up visit will include a TMD exam, questionnaires, and pressure pain threshold measures. Analyses will determine intervention effects on the primary outcome (pain intensity) and multiple secondary outcomes and will examine whether changes in inflammation and pain sensitivity are associated with the intervention response. Clinicaltrials.gov