The influence of educational measures and low-level laser phototherapy on temporomandibular disorders: Study protocol clinical trial (SPIRIT Compliant)

Photobiomodulation therapy (PBMT) with low-power laser is used for pain relief in several clinical conditions, including temporomandibular disorders (TMD). As musculoskeletal pain often produces changes in motor behavior, it is common for patients with TMD to present limited mandibular movements. To the date, there is no consensus about the optimal dosimetric parameters of PMBT for TMD. This randomized, controlled, double-blind clinical trial aims to evaluate pain relief and mandibular mobility in patients with TMD following treatments with 2 laser wavelengths, red (660 nm) and infrared (808 nm) individually and in combination as compared to a placebo treatment. One-hundred participants presenting myalgia and arthralgia, with disk displacement or not, will be selected based on the Research Diagnostic Criteria for Temporomandibular Disorders. All participants will be instructed about the etiology, prognosis, and self-care techniques for pain control on TMD, and followed up for 2 weeks. After this period, those who still present pain score over 4 in a visual analog scale (VAS) will be included in the study. Participants will be randomly assigned to 4 treatment groups: G1 = placebo (SHAM); G2 = PBMT with red laser (660 nm, 0.034 cm(2), 88 J/cm(2), 100 mW, 3 J/point); G3 = PBMT with infrared laser (808 nm, 0.034 cm(2), 88 J/cm(2), 100 mW, 3 J/point); and G4 = PBMT with red and infrared laser alternated between sessions. The treatment consists of 8 sessions, 2 times a week. The effect of the proposed therapies will be measured by: pain reduction in VAS; pressure pain threshold on TMJ, masseter and temporal muscles; and the amplitude of mandibular movements (opening, protrusion, and right and left lateral movements). The data will be collected at the following times: initial (T1), after the 1st treatment session (T2), at the end of treatment (T3), and 30 days after the last PBMT session (T4). For statistical analysis will be used 2-way repeated measures analysis of variance test, complemented by a post hoc Tukey test (P < .05).