Additional effect of pain neuroscience education to craniocervical manual therapy and exercises for pain intensity and disability in temporomandibular disorders: a study protocol for a randomized controlled trial

ABSTRACT: The objective of this study will be to investigate the additional effect of pain neuroscience education program compared to a craniocervical manual therapy and exercises program for pain intensity and disability in patients with temporomandibular disorders (TMD). This study will be a randomized controlled trial comprising a sample of 148 participants. Subjects between 18 and 55 years, both genders, will undergo a screening process to confirm painful TMD by the Research Diagnostic Criteria (RDC/TMD), and then the volunteers will be randomized into two groups (G1: pain neuroscience education + craniocervical manual therapy and exercises vs. G2: craniocervical manual therapy and exercises). The volunteers will be recruited at the dentistry clinic. The intervention will be administered twice a week for 6 weeks by a single therapist lasting 1 h per session. The primary outcome will be pain intensity and disability and the secondary outcomes will be pain self-efficacy, kinesiophobia, and global perceived effect of improvement. The participants will be assessed immediately after the last session and at one- and three-month follow-ups. All statistical analyses will be conducted following intention-to-treat principles, and the treatment effects will be calculated using linear mixed models. The results of this study may contribute to understand the additional effect of pain neuroscience education intervention on TMD patients submitted to manual therapy and exercise. TRIAL REGISTRATION: ClinicalTrials.gov NCT03926767. Registered on April 29, 2019.