Photobiomodulation therapy on the palliative care of temporomandibular disorder and orofacial/cervical skull pain: study protocol for a randomized controlled clinical trial

BACKGROUND: Temporomandibular disorder (TMD) is the most common cause of orofacial and cervical skull pain and is considered to be a public health problem, affecting 5% to 12% of the world population. TMD is multifactorial and there are several types of treatment, with the conservative types being indicated more often as they are less aggressive and reversible. The main aim of these treatments is to relieve symptoms, reduce of pain, and restore orofacial and cervical skull functions. Photobiomodulation therapy (PBMT), a noninvasive therapy, is an option for the management of musculoskeletal disorders due to its analgesic, anti-inflammatory, and regenerative effects. METHODS: The aim of the proposed study is to verify whether PBMT is effective for use in palliative care of TMD and orofacial and cervical skull pain. A randomized, triple-blinded, placebo-controlled clinical trial is proposed. This study will involve 200 adult participants (over 18 years of age) who will be randomly divided into two groups (n = 100): Group 1, active treatment (PBMT); and Group 2, placebo. Participants will be subjected to three sessions of PBMT or placebo and will be evaluated using the research diagnostic criteria (RDC) for TMD. Pain level (measured by a visual analog scale (VAS)), mandibular movements (measured by ruler and caliper), quality of life (measured by the Oral Health Impact Profile (OHIP)-14), and quality of sleep (measured by the Epworth scale) will be recorded. This study is being conducted at the Special Laboratory of Lasers in Dentistry (LELO) of the School of Dentistry of the University of Sao Paulo (USP). DISCUSSION: This study will verify whether PBMT is effective in reducing TMD and orofacial and cervical skull pain. PBMT may be an option for the management of musculoskeletal disorders due to its analgesic, anti-inflammatory, and regenerative effects, in addition to being a noninvasive technique. TRIAL REGISTRATION: Registro Brasileiro de Ensaios Clínicos, RBR-9b6mnj. Registered on 27 March 2018. Trial registry name: Laser de baixa potência no cuidado paliativo da disfunção temporomandibular e dor crânio orofacial e cervical. Ethics committee: #1774930 approved on 14 October 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-019-3294-7) contains supplementary material, which is available to authorized users.