Primary studies included in this systematic review

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Primary study

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Efficacy of botulinum toxin therapy in treatment of myofascial pain.

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Journal Journal of oral science
Year 2017
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This article is included in 1 Systematic review Systematic reviews (1 reference)

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The present study aimed to assess the efficacy of using botulinum toxin (BTX) in temporomandibular joint disorders, particularly pertaining to myofascial pain from masseter and temporal muscles. The study included 11 patients who were diagnosed with masseter and temporalis myofascial pain. Visual analog scale for pain and pressure algometry were conducted initially, after 1 month of conservative therapy (control group), and after 1 month of BTX type A injections (study group). Data were statistically analyzed (analysis of variance and Wilcoxon's test) to determine intergroup differences. Both conservative therapy and BTX injections showed reduction in pain scores and increase in pain threshold compared with baseline, and statistically significant differences were noted between both groups. Thus, BTX injections appear to be effective in management of chronic myofascial pain targeting masseter and temporalis muscles.

Primary study

Unclassified

IncobotulinumtoxinA Injection for Temporomandibular Joint Disorder.

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Authors Patel AA , Lerner MZ , Blitzer A
Journal The Annals of otology, rhinology, and laryngology
Year 2017
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This article is included in 4 Systematic reviews Systematic reviews (4 references)

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OBJECTIVES: Temporomandibular disorder (TMD) involves dysfunction of the temporomandibular joint and associated muscles of mastication causing pain with chewing, limitation of jaw movement, and pain. While the exact pathophysiology of TMD is not completely understood, it is thought that hyperfunction of the muscles of mastication places stress on the temporomandibular joint, leading to degeneration of the joint and associated symptoms. We hypothesize that chemodenervation of the muscles of mastication with IncobotulinumtoxinA (Xeomin) will decrease the stress on the temporomandibular joint and improve pain associated with temporomandibular joint and muscle disorder (TMJD). METHODS: Twenty patients were randomized to IncobotulinumtoxinA (170 units) or saline injection of the masticatory muscles. Patient-reported pain scale (0-10) was recorded at 4-week intervals following injection for 16 weeks. Patients who received saline injection initially were assessed for reduction in pain at the first 4-week interval and if still had significant pain were rolled over into the IncobotulinumtoxinA arm. RESULTS: Preinjection pain scores were similar between patients. While there was a statistically significant reduction in pain score in the placebo group one month, there was an overall larger drop in average pain scores in those patients injected with IncobotulinumtoxinA initially. All patients initially injected with placebo crossed over into the IncobotulinumtoxinA group. Similar results were seen when examining the composite masticatory muscle tenderness scores. There was no significant change in usage of pain medication. CONCLUSIONS: We demonstrate utility of IncobotulinumtoxinA in treating patients with TMD with pain despite pain medication usage and other conventional treatments.

Primary study

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Occlusal force characteristics of masseteric muscles after intramuscular injection of botulinum toxin A(BTX - A)for treatment of temporomandibular disorder.

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Authors Zhang LD , Liu Q , Zou DR , Yu LF
Journal The British journal of oral & maxillofacial surgery
Year 2016
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This article is included in 5 Systematic reviews Systematic reviews (5 references)

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Our aim was to evaluate the occlusal force and therapeutic efficacy of the masseteric muscles after intramuscular injection of botulinum toxin A (BTX-A) for the treatment of patients with concurrent temporomandibular disorders (TMD) and bruxism. Thirty patients with TMD associated with bruxism were randomised into three groups (n=10 in each group), and treated by bilateral intramuscular injection of BTX-A into the masseter, placebo, or control. We used an occlusal force analysis system to collect several measures of occlusal force such as duration of biting and closing, the maximum occlusal force, and the distribution of occlusal force. The occlusal force in the intercuspid position was reduced in all three groups. There was a significant difference between the BTX-A and placebo groups (F(df=1)=8.08, p=0.01) but not between the control group and the other two(F(df=1)=4.34, p=0.047). The duration of occlusion was significantly increased in the BTX-A group after 3 months' treatment (t=4.07, p=0.003). The asymmetrical distribution of occlusal force was reduced in all three groups, but not significantly so (Levene's test F(df=2)=0.25, p=0.78,ANOVA F(df=2)=0.50, p=0.61). Treatment of TMD with BTX-A is effective in reducing the occlusal force, but psychological intervention plays an important part in treatment.

Primary study

Unclassified

The effect of laser and botulinum toxin in the treatment of myofascial pain and mouth opening: A randomized clinical trial.

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Journal Journal of photochemistry and photobiology. B, Biology
Year 2016
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This article is included in 5 Systematic reviews Systematic reviews (5 references)

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This study conducted a randomized clinical trial in 15 patients, who sought care at the Dental Clinic of the University of Passo Fundo, in order to compare the use of low-level laser and botulinum toxin in the treatment of myofascial pain and whether they alter the mouth opening of patients with temporomandibular disorder. The patients were divided into two groups: the Laser group received low-level GaAlAs laser, 100mW of power at a wavelength of 830nm in continuous light emission; and the Toxin group received 30U of botulinum toxin type A (BTX-A) in the first session, and 15U after fifteen days. The assessments were performed by measuring pain with Visual Analogue Scale (VAS), and mouth opening with a digital caliper. Data were submitted to Student's t test at 5% significance level. Regarding pain symptoms, the results indicate that groups treated with laser and toxin registered 7U in VAS, at day 5 the scores were 4.75 and 4.86U, respectively. The laser worked faster (day 12) at 2.75U, and the group treated with BTX-A registered 2.86U at day 30. Both therapies investigated were effective in reducing pain, but the effect of low-level laser was faster than the use of BTX-A. Both treatments showed no statistically significant improvement in mouth opening.

Primary study

Unclassified

Myofascial pain of the jaw muscles: comparison of short-term effectiveness of botulinum toxin injections and fascial manipulation technique.

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Journal Cranio : the journal of craniomandibular practice
Year 2012
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This article is included in 10 Systematic reviews Systematic reviews (10 references)

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A randomized controlled trial was performed to compare the short-term effectiveness of botulinum toxin injections and physiatric treatment provided by means of Fascial Manipulation techniques in the management of myofascial pain of jaw muscles. Thirty patients with a Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) diagnosis of myofascial pain were randomized to receive either single-session botulinum toxin injections (Group A) or multiple-session Fascial Manipulation (Group B). Maximum pain levels (VAS ratings) and jaw range of motion in millimeters (maximum mouth opening, protrusion, right and left laterotrusion) were assessed at baseline, at the end of treatment, and at a three-month follow-up. Both treatment protocols provided significant improvement over time for pain symptoms. The two treatments seem to be almost equally effective, Fascial Manipulation being slightly superior to reduce subjective pain perception, and botulinum toxin injections being slightly superior to increase jaw range of motion. Differences between the two treatment protocols as to changes in the outcome parameters at the three-months follow-up were not relevant clinically. Findings from the present investigation are in line with literature data supporting the effectiveness of a wide spectrum of conservative treatment approaches to myofascial pain of the jaw muscles. Future studies on larger samples over a longer follow-up span are needed on the way to identify tailored treatment strategies.

Primary study

Unclassified

Efficacy of botulinum toxin type A for treatment of persistent myofascial TMD pain: a randomized, controlled, double-blind multicenter study.

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Journal Pain
Year 2011
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This article is included in 13 Systematic reviews Systematic reviews (13 references)

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Evidence of an effect by botulinum toxins is still lacking for most pain conditions. In the present randomized, placebo-controlled, crossover multicenter study, the efficacy of botulinum toxin type A (BTX-A) was investigated in patients with persistent myofascial temporomandibular disorders (TMD). Twenty-one patients with myofascial TMD without adequate pain relief after conventional treatment participated. A total of 50 U of BTX-A or isotonic saline (control) was randomly injected into 3 standardized sites of the painful masseter muscles. Follow-up was performed after 1 and 3 months, followed by a 1-month washout period, after which crossover occurred. Pain intensity at rest was the primary outcome measure, while physical and emotional function, global improvement, side effects, and clinical measures were additional outcome measures. There was no main difference between drugs (ANOVA; P=.163), but there was a significant time effect (P<.001), so BTX-A reduced mean (SD) percent change of pain intensity by 30 (33%) after 1 month and by 23 (30%) after 3 months compared to 11 (40%) and 4 (33%) for saline. The number of patients who received a 30% pain reduction was not significantly larger for BTX-A than after saline at any follow-up visit. The number needed to treat was 11 after 1 month and 7 after 3 months. There were no significant changes after treatment in any other outcome measures, with the exception of pain on palpation, which decreased 3 months after saline injection (P<.05). These results do not indicate a clinical relevant effect of BTX-A in patients with persistent myofascial TMD pain.

Primary study

Unclassified

Effect of botulinum toxin injection on nocturnal bruxism: A randomized controlled trial

Authors Lee SJ , McCall WD , Kim YK , Chung SC , Chung JW
Journal American journal of physical medicine & rehabilitation / Association of Academic Physiatrists
Year 2010
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This article is included in 14 Systematic reviews Systematic reviews (14 references)

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Objective: To evaluate the effect of botulinum toxin type A on nocturnal bruxism. Design: Twelve subjects reporting nocturnal bruxism were recruited for a double-blind, randomized clinical trial. Six bruxers were injected with botulinum toxin in both masseters, and six with saline. Nocturnal electromyographic activity was recorded in the subject's natural sleeping environment from masseter and temporalis muscles before injection, and 4, 8, and 12 wks after injection and then used to calculate bruxism events. Bruxism symptoms were investigated using questionnaires. Results: Bruxism events in the masseter muscle decreased significantly in the botulinum toxin injection group (P = 0.027). In the temporalis muscle, bruxism events did not differ between groups or among times. Subjective bruxism symptoms decreased in both groups after injection (P < 0.001). Conclusions: Our results suggest that botulinum toxin injection reduced the number of bruxism events, most likely mediated its effect through a decrease in muscle activity rather than the central nervous system. We controlled for placebo effects by randomizing the interventions between groups, obtaining subjective and objective outcome measures, using the temporalis muscle as a control, and collecting data at three postinjection times. Our controlled study supports the use of botulinum toxin injection as an effective treatment for nocturnal bruxism. © 2009 by Lippincott Williams & Wilkins.

Primary study

Unclassified

Effect of botulinum toxin-A in myofascial pain patients with or without functional disc displacement.

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Journal Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons
Year 2008
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This article is included in 1 Broad synthesis Broad syntheses (1 reference) 13 Systematic reviews Systematic reviews (13 references)

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<b>PURPOSE: </b>To evaluate the effects of botulinum toxin-A in the treatment of patients who have myofascial pain with or without functional disc displacement. <b>Patients and METHODS: </b>Twenty-four participants were randomly assigned to the study by using Research Diagnostic Criteria for Temporomandibular Disorders. All patients were informed about botulinum toxin-A, and were required to give informed consent. Before the injections, patients were asked to fill out a Biobehavioral Questionnaire to evaluate their pain and psychological status, and afterward, electromyography of the right and left masseter and anterior temporal muscles was recorded. Saline was injected into the masseter and anterior temporal muscles in the placebo group, and botulinum toxin-A was used in the study group. On days 14 and 28, patients were asked to fill out a Biobehavioral Questionnaire again, and electromyography of the right and left masseter and anterior temporal muscles was recorded again. <b>RESULTS: </b>The study group showed improvement in pain and psychological status. Although a decrease in the action potentials of the masseter muscles on day 14 was followed by an increase on day 28, the reduction of pain scores and improvement in psychological status continued on day 28. <b>CONCLUSIONS: </b>The injection of botulinum toxin-A decreases the muscle action potential in 14 days. The patients also show improvement in pain and psychological status.

Primary study

Unclassified

Efficacy of Botulinum Toxin in Treating Myofascial Pain in Bruxers: A Controlled Placebo Pilot Study.

Journal Cranio : the journal of craniomandibular practice
Year 2008
Links Pubmed DOI

This article is included in 24 Systematic reviews Systematic reviews (24 references) 1 Broad synthesis Broad syntheses (1 reference) 1 Structured summary of primary studies Structured summaries of primary studies (1 reference)

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The present investigation is a preliminary double-blind, controlled placebo, randomized clinical trial with a six month follow-up period. The study aimed to assess the efficacy of type A botulinum toxin (Botox, Allergan, Inc. Irvine, CA) to treat myofascial pain symptoms and to reduce muscle hyperactivity in bruxers. Twenty patients (ten males, ten females; age range 25-45) with a clinical diagnosis of bruxism and myofascial pain of the masticatory muscles were enrolled in a double-blind, controlled placebo, randomized clinical trial, with a treatment group (ten subjects treated with botulinum toxin injections- BTX-A) and a control group (ten subjects treated with saline placebo injections). A number of objective and subjective clinical parameters (pain at rest and during chewing; mastication efficiency; maximum nonassisted and assisted mouth opening, protrusive and laterotrusive movements; functional limitation during usual jaw movements; subjective efficacy of the treatment; tolerance of the treatment) were assessed at baseline time and at one week, one month, and six months follow-up appointments. Descriptive analysis showed that improvements in both objective (range of mandibular movements) and subjective (pain at rest; pain during chewing) clinical outcome variables were higher in the Botox treated group than in the placebo treated subjects. Patients treated with BTX-A had a higher subjective improvement in their perception of treatment efficacy than the placebo subjects. Differences were not significant in some cases due to the small sample size. Results from the present study supported the efficacy of BTX-A to reduce myofascial pain symptoms in bruxers, and provided pilot data which need to be confirmed by further research using larger samples.

Primary study

Unclassified

Type A botulinum toxin in the treatment of chronic facial pain associated with masticatory hyperactivity.

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Journal Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons
Year 2003
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This article is included in 12 Systematic reviews Systematic reviews (12 references) 1 Broad synthesis Broad syntheses (1 reference)

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PURPOSE: Chronic hyperactivity of the masticatory muscles is a common functional disorder associated with chronic facial pain and headache. The positive therapeutic effect of botulinum toxin type A on functional disorders and pain symptoms has been known in connection with the treatment of cervical dystonia. The purpose of this report is to assess whether the targeted reduction of masticatory muscular hyperactivity by local injection treatment with botulinum toxin type A can improve facial pain headache symptoms in the event that other treatment methods prove ineffective. MATERIALS AND METHODS: In an randomized blinded placebo-controlled study, 90 patients (60 verum and 30 placebo) with chronic facial pain were treated with botulinum toxin type A (Botox; Allergan, Ettlingen, Germany) injections into masticatory muscles. RESULTS: Ninety-one percent of patients who received botulinum toxin improved by a significant mean reduction of approximately 3.2 on a visual analog pain scale. By comparison with t test and chi(2) test, there was a significant difference compared with the placebo group (P <.01). CONCLUSIONS: The local injection of botulinum toxin type A constitutes an innovative and adequately efficient treatment method for chronic facial pain associated with hyperactivity of the masticatory muscles. An improvement in the painful symptoms can be expected in up to 90% of patients who do not respond to conservative treatment methods.