Abstract
BACKGROUND: Temporomandibular Disorders (TMD) are musculoskeletal disorders that affect the chewing structures and has a complex and multifactorial etiology. A biopsychosocial approach is recommended for the management of these disorders considering the multifactorial nature of TMD etiology. The aim of this study is to compare the effect of condensed Pain Science Education (PSE) program (2 initial sessions of 75 min) versus longitudinally administered PSE (6 sessions of 25 min) combined with manual therapy and neck motor control exercises (NMCE) on primary outcomes-pain intensity and disability-and secondary outcomes - mandibular range of motion, pain self-efficacy, fear of movement, global perceived effect of improvement, empathy, knowledge about pain neuroscience, beliefs about pain, exercise adherence, and pain catastrophizing-in patients with painful TMD. METHODS: This study will be a randomized controlled trial with a sample of 148 participants. Participants will undergo a screening process to identify TMD according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD), aged 20 to 60 years, of both sexes, and then the volunteers will be randomized into two groups (G1: Condensed PSE + Manual therapy/orofacial and NMCE vs. G2: Longitudinal PSE + Manual therapy/orofacial and NMCE). The exercise intervention will take place once a week for 8 weeks, conducted by a physiotherapist, with each session lasting 1 h. The interventions will be administered by trained care providers. The primary outcomes will be pain intensity and disability, assessed using the numeric pain rating scale and the Craniofacial Pain and Disability Inventory (CF-PDI), respectively. For statistical analysis, a linear mixed models considering time and groups as factors will be used. A significance level of p < 0.05 will be considered. DISCUSSION: To date, no randomized controlled trial has yet been conducted to compare the effect of different modes of PSE delivery on pain intensity and disability in patients with painful chronic TMD. TRIAL REGISTRATION: NCT06259344. Registered on February 14, 2024. https://classic. CLINICALTRIALS: gov/ct2/show/NCT06259344.