RESUMO
BACKGROUND: This study aimed to elucidate the effects of botulinum toxin A (BoNT-A) treatment for patients diagnosed with masseter hypertrophy on the temporalis muscle, with a particular focus on assessing alterations in muscle thickness, electromyographic (EMG) activity, and the development of muscle pain. METHODS: The present randomized triple-blinded clinical trial enrolled 26 female participants aged between 25 and 50 years complaining about masseter hypertrophy. Participants received 75U of BoNT-A (abobotulinumtoxinA) in both masseter muscles and after three months were randomized to receive a second treatment session of saline solution (S-BoNT-A) or BoNT-A (M-BoNT-A). Longitudinal assessments included temporalis muscle thickness through ultrasound, EMG activity, subjective pain, and masseter prominence severity after one, three, and six months of the first injection session. Muscle thickness, EMG, and subjective pain were analysed using two-way ANOVA with repeated measures and post hoc Sidak test, and for masseter prominence severity, Friedman and Mann-Whitney tests were used. RESULTS: Regarding inter-group comparisons, a higher muscle thickness (p < 0.02) and a higher EMG activity (p < 0.01) were found in the M-BoNT-A group at the 6-month follow-up. For subjective pain assessments, inter-group comparisons showed a higher prevalence of painful regions in M-BoNT-A group at the 6-month follow-up (p < 0.02). No significant differences were found in masseter prominence severity at the 6 months assessment between groups. CONCLUSION: BoNT-A treatment for masseter hypertrophy lead to structural and functional changes in the temporalis muscle, presenting higher changes after multiple injections of this treatment. LEVEL OF EVIDENCE I: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
RESUMO
BACKGROUND: Forehead aesthetic injections are a well-known source of discomfort, and many analgesic non-invasive techniques have been proposed to ameliorate pain. However, no study has compared all these techniques for aesthetic purposes. Therefore, this study aimed to compare the effectiveness of topical cream anesthesia, vibratory stimulus, cryotherapy, pressure, and even no intervention, on pain during and immediately after injection, when considering aesthetic injections in the forehead. METHODS: Seventy patients were selected and had their foreheads divided into 5 parts, which received four different analgesic techniques, and one control zone was added. A numeric rating scale was used to assess pain, two direct questions were asked to evaluate patients' preference and discomfort with the techniques, and the adverse events were quantified. The injections were performed in the same sequence, with three minutes of rest between them and in a single session. Comparisons among analgesic methods for pain relief were performed by the one-way analysis of variance (ANOVA), considering a significance level of 5%. RESULTS: No significant differences were found among the analgesic methods, and between the methods and the control zone, both during and immediately after the injections (p > 0.05). The preferred method for pain relief was the use of topical anesthetic cream (47%), while the most uncomfortable technique was manual distraction (pressure) (36%). Only one patient reported an adverse event. CONCLUSIONS: No analgesic method to diminish pain was superior to the others or was better than no method. Nevertheless, the topical anesthetic cream was the preferred technique, causing less discomfort. LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .