Botulinum toxin-A effects on pain, somatosensory and psychosocial features of patients with refractory masticatory myofascial pain: a randomized double-blind clinical trial.

The antinociceptive effect of BoNT-A have been well documented in animal studies; however, results of few but well-designed randomized placebo-controlled clinical trials about BoNT-A efficacy in masticatory myofascial pain (MFP) are inconsistent. Therefore, the present randomized, double-blind, placebo-controlled clinical trial evaluated the efficacy of BoNT-A in patients with refractory MFP. Twenty-eight patients with pain reduction of less than 30% despite conservative treatment and with an average pain intensity of > 50 mm on the visual analogue scale (VAS) participated. Patients were randomly assigned to receive a total of 80 U of BoNT-A or saline solution (SS) injected into the masseter and anterior temporalis muscles. Pain intensity (VAS), quantitative sensory testing (QST), conditioned pain modulation (CPM), and psychosocial status were examined. Follow-up was performed at 1 and 6 months. For repeated-measure comparisons between evaluation times, Friedman test with Bonferroni correction was used for pain and somatosensory variables and the Wilcoxon test for the psychosocial variables. The Mann-Whitney test was used for all comparisons between groups. The BoNT-A group had a significant decrease in pain intensity at follow-ups compared with the SS group (p < 0.001). QST assessment revealed higher pressure pain threshold values in the masseter muscle for BoNT-A group compared to SS (p < 0.03) at all follow-ups. No differences were found for mechanical pain threshold and wind-up ratio values (p > 0.05) in the entire study. The BoNT-A group presented the most efficient CPM effect (p < 0.03) only at the 1 month follow-up in the masseter muscle. There was a significant time effect for BoNT-A in all psychosocial variables (p < 0.05) and a drug effect in the Central Sensitization Inventory (p < 0.01), Pittsburgh Sleep Quality Index (p < 0.004), and Healthy Survey 36 (p < 0.05) at 6 months follow-up. The study demonstrates that a single injection-session of BoNT-A has positive effects on the hall pain spectrum of patients with refractory masticatory myofascial pain.

Long-Term Effects of a Single Application of Botulinum Toxin Type A in Temporomandibular Myofascial Pain Patients: A Controlled Clinical Trial.

This study assessed the long-term effects of botulinum toxin type A (BoNT-A) in subjective pain, pain sensibility, and muscle thickness in persistent myofascial temporomandibular-disorder pain (MFP-TMD) patients. Fourteen female subjects with persistent MFP received BoNT-A treatment with different doses (10U-25U for temporalis muscle and 30U-75U for masseter muscle). The treatment was injected bilaterally in the masseter and anterior temporalis muscles in a single session. Clinical measurements included: self-perceived pain (VAS), pain sensibility (PPT), and muscles thickness (ultrasonography). Follow-up occurred 1, 3, 6, and 72 months after treatment for VAS and PPT and 1, 3, and 72 months for ultrasonography. For statistical analysis, the Friedman test with the Bonferroni test for multiple comparisons as a post hoc test was used for non-parametric repeated measures comparisons among the evaluation times. A 5% probability level was considered significant in all tests. VAS values presented a significant decrease throughout the study (p < 0.05). Regarding PPT values, a significant increase was found when comparing baseline data with post-treatment follow-ups (p < 0.05), and even though a significant decrease was found in muscle thickness when baseline values were compared with the 1- and 3-months assessments, no differences were found when compared with the 72 months follow-up (p > 0.05). A single injection of BoNT-A presents long-term effects in reducing pain in persistent MFP-TMD patients, and a reversibility of adverse effects on masticatory-muscle thickness.

Botulinum toxin type A and acupuncture for masticatory myofascial pain: a randomized clinical trial.

BACKGROUND: BoNT-A has been widely used for TMD therapy. However, the potential benefits compared to dry needling techniques are not clear. OBJECTIVE: this study aimed to compare the immediate effects of botulinum toxin type A (BoNT-A) injections and Acupuncture in myofascial temporomandibular disorders (TMD) patients. METHODOLOGY: 54 women were divided into three groups (n=18). AC patients received four sessions of traditional acupuncture, being one session/week during 20-min. BoNT-A patients were bilaterally injected with 30U and 10U in masseter and anterior temporal muscles, respectively. Moreover, a control group received saline solution (SS) in the same muscles. Self-perceived pain was assessed by visual analog scale, while pressure pain threshold (PPT) was verified by a digital algometer. Electromyographic evaluations (EMG) of anterior temporal and masseter muscles were also measured. All variables were assessed before and 1-month after therapies. The mixed-design two-way repeated measures ANOVA and Tukey's post-hoc tests were used for analysis, considering a=0.05. RESULTS: Self-perceived pain decreased in all groups after one month of therapy (P<.001). BoNT-A was not better than AC in pain reduction (P=0.05), but both therapies were more effective in reducing pain than SS (P<0.05). BoNT-A was the only treatment able to improve PPT values (P<0.05); however, a severe decrease of EMG activity was also found in this group, which is considered an adverse effect. CONCLUSION: after one month of follow-up, all therapies reduced the self-perceived pain in myofascial TMD patients, but only BoNT-A enhanced PPT yet decreased EMG.

Botulinum toxin type A and acupuncture for masticatory myofascial pain: a randomized clinical trial

Abstract BoNT-A has been widely used for TMD therapy. However, the potential benefits compared to dry needling techniques are not clear. Objective this study aimed to compare the immediate effects of botulinum toxin type A (BoNT-A) injections and Acupuncture in myofascial temporomandibular disorders (TMD) patients. Methodology 54 women were divided into three groups (n=18). AC patients received four sessions of traditional acupuncture, being one session/week during 20-min. BoNT-A patients were bilaterally injected with 30U and 10U in masseter and anterior temporal muscles, respectively. Moreover, a control group received saline solution (SS) in the same muscles. Self-perceived pain was assessed by visual analog scale, while pressure pain threshold (PPT) was verified by a digital algometer. Electromyographic evaluations (EMG) of anterior temporal and masseter muscles were also measured. All variables were assessed before and 1-month after therapies. The mixed-design two-way repeated measures ANOVA and Tukey's post-hoc tests were used for analysis, considering a=0.05. Results Self-perceived pain decreased in all groups after one month of therapy (P<.001). BoNT-A was not better than AC in pain reduction (P=0.05), but both therapies were more effective in reducing pain than SS (P<0.05). BoNT-A was the only treatment able to improve PPT values (P<0.05); however, a severe decrease of EMG activity was also found in this group, which is considered an adverse effect. Conclusion after one month of follow-up, all therapies reduced the self-perceived pain in myofascial TMD patients, but only BoNT-A enhanced PPT yet decreased EMG.