Key Contribution
temporomandibular disorders, headaches, TMDs, masticatory muscle pains, masticatory muscle pain, orofacial pain, headache, myogenous TMD, tenderness, capitis, OVAS
TEMPOROMANDIBULAR DISORDERS, DISORDERS
These authors contributed equally to this work.This study aimed to evaluate the efficacy of botulinum toxin type A (BoNT/A) in patients with temporomandibular disorders (TMDs) associated with masticatory muscle pain (MMP) and headaches. This randomized, double-blind, placebo-controlled pilot study is the first clinical trial to evaluate both disorders simultaneously. Twenty-one patients with myogenous TMD were randomly assigned to two groups. The experimental and control groups received injections of either BoNT/A or saline into the sites showing tenderness after palpation of a total of 16 muscle areas, including each masseter, a temporalis, splenius capitis, sternocleidomastoid, and trapezius muscle. During each visit, the clinical effects, based on the intensity of orofacial pain (OVAS), headache (HVAS), number of tender points (TPs), maximum mouth opening (MMO), and headache frequency (HF), were evaluated at four time points, namely, pre-injection and 4, 8, and 12 weeks after the injection, in both groups. Friedman and Mann–Whitney tests were used for the analyses. In the experimental group, the reductions in OVAS, TP, HVAS, and HF showed significant differences over time, excluding MMO, whereas there was no significant difference in any of the variables in the control group. In addition, the decline in TPs was significantly different between the experimental and control groups at all time points, especially after 4 and 12 weeks, compared to that during pre-injection. In conclusion, treatment with BoNT/A was relatively effective for masticatory muscle pain caused by TMDs and headache compared to the saline placebo.Significant values were observed over time following the administration of Botulinum toxin injections, and the number of tender points decreased significantly. Based on the findings of our study, Botulinum toxin injection can be suggested as a partially effective treatment for patients with masticatory muscle pains caused by temporomandibular disorders and headache.