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Randomized Controlled Trial
. 2023 Oct 4;15(10):597.
doi: 10.3390/toxins15100597.

Effect of Botulinum Toxin on Masticatory Muscle Pain in Patients with Temporomandibular Disorders: A Randomized, Double-Blind, Placebo-Controlled Pilot Study

So Ra Kim  1 , Min Chang  1 , Alec Hyung Kim  2 , Seong Taek Kim  1
Affiliations
Randomized Controlled Trial

Effect of Botulinum Toxin on Masticatory Muscle Pain in Patients with Temporomandibular Disorders: A Randomized, Double-Blind, Placebo-Controlled Pilot Study

So Ra Kim et al. Toxins (Basel). .

Abstract

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.

Keywords: botulinum toxin type A; headache; masticatory muscle pain; temporomandibular disorders.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
(a) OVAS change by group; (b) TP change by group; (c) MMO change by group; (d) HVAS change by group; (e) HF change by group. OVAS, the intensity of orofacial pain; TPs, the number of tender points; MMO, maximum mouth opening (mm); HVAS, the intensity of headache; HF, headache frequency per month; Exp, experimental group; Con, control group; pre-, pre-injection.
Figure 1
Figure 1
(a) OVAS change by group; (b) TP change by group; (c) MMO change by group; (d) HVAS change by group; (e) HF change by group. OVAS, the intensity of orofacial pain; TPs, the number of tender points; MMO, maximum mouth opening (mm); HVAS, the intensity of headache; HF, headache frequency per month; Exp, experimental group; Con, control group; pre-, pre-injection.
See this image and copyright information in PMC

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