Combined rehabilitation therapy with botulinum toxin to the upper limbs for acute spinal cord injury: A case report.

INTRODUCTION: Patients with spinal cord injury (SCI) and incomplete paralysis may experience muscle immobilization due to functional impairment of agonist and antagonist muscles. This can induce spasticity and pain, with the risk of contracture increasing as the period of immobilization increases. This could be aggravated by pain, which interferes with rehabilitation. There is no established treatment for pain and joint contractures caused by acute SCI. Botulinum therapy plays a role in relieving muscle tension. Here, we report a case of acute SCI in which botulinum therapy was administered. CASE PRESENTATION: The patient experienced a C5-cervical SCI due to a road traffic accident, with marked paralysis in the upper and lower limbs below the C5 level. The patient had persistent elbow flexion since the SCI and complained of excruciating pain, making adequate rehabilitation difficult. Botulinum toxin was administered to the biceps and brachialis muscles 15 days after the SCI. After administration, the patient experienced a reduction in pain with relaxation of the elbow flexor muscles, and rehabilitation treatment was resumed. This patient's contracture did not worsen, his pain decreased, and he was able to initiate self-feeding training. DISCUSSION: In this case, occupational and physical therapy was administered with botulinum therapy. Together, they successfully reduced pain. Botulinum therapy provides analgesia and muscle relaxation and may lead to functional recovery, and we believe that treatment can be considered even in the acute phase.

Paradoxical masseteric bulging after botulinum neurotoxin type A injection.

Paradoxical masseteric bulging refers to an unexpected occurrence of masseter muscle bulging or protrusion following the administration of botulinum toxin injections, contrary to the anticipated muscle weakening effect. It may occur secondary to toxin failing to diffuse through the entire masseter muscle due to the presence of an inferior tendon structure within the superficial masseter that divides it into a superficial and deep belly. We report a clinical case of paradoxical masseteric bulging in a female in her late 40s who developed this adverse effect within a week of her masseter botulinum neurotoxin type A injections. We also describe the masseter two-site injection technique for the management of this complication.

Effectiveness of Extracorporeal Shock Wave Therapy after Botulinum Toxin Injection for Post-Stroke Upper Extremity Spasticity: A Randomized Controlled Study.

Post-stroke spasticity is a common complication that limits the functional performance of patients. Botulinum toxin (BTx) is an effective treatment for spasticity. Numerous researchers have applied extracorporeal shock wave therapy (ESWT) to address post-stroke spasticity, yielding positive clinical outcomes. We aimed to clarify the add-on effects of ESWT on BTx therapy for spasticity in patients with post-stroke. Sixteen eligible patients with upper extremity spasticity after stroke were recruited for this study. They were randomized to either a BTx with focused ESWT treatment group or a BTx alone group. Spasticity, measured using the modified Ashworth score (MAS) and modified Tardieu scale (MTS), showed statistically significant improvements in the elbow and wrist flexor muscles in both BTx + ESWT group and BTx alone groups. However, no significant differences were observed between the two groups with time flow. The BTx + ESWT group showed significantly decreased MAS of the finger flexors at follow-up and increased R1 (MTS) of the finger flexors at 3 weeks after treatment, which was not observed in the BTx alone group. This is the first study to identify the add-on effect of ESWT on BTx injections to improve post-stroke upper limb spasticity.

Nerve Block Guided by Anatomic Landmarks Only Reduces Pain in Botulinum Toxin Type A Treatment for Glabellar and Forehead Wrinkles.

BACKGROUND: Botulinum toxin type A is widely used to treat glabellar and forehead wrinkles, but the pain caused by multiple injections often deters patients from receiving long-term treatment. Despite several methods used to alleviate this pain, consistency and effectiveness remain a challenge. Therefore, this study aimed to evaluate the effectiveness and safety of nerve block guided by anatomic landmarks only in reducing pain associated with botulinum toxin type A injections. PATIENTS AND METHODS: Between 2018 and 2022, the study enrolled 90 patients divided into 3 groups: the nerve block group (n = 30), the lidocaine cream group (n = 30), and the control group (n = 30). In the nerve block group, a landmarks-based technique was used to perform the nerve block. The study collected general information and comorbidities, and recorded pain at each point and time spent on preparation and treatment for each patient's forehead and glabellar area on each side. Patient-reported outcomes and complications were followed up at 2, 4, and 12 weeks after the injections. RESULTS: The nerve block group had significantly lower total pain scores in all regions compared to the lidocaine cream and control groups (P < 0.01). There were no significant differences in patient-reported outcomes between the groups at any follow-up point. Additionally, the complication rates related to injection were low and comparable among the 3 groups. CONCLUSIONS: Nerve block guided by anatomic landmarks only is a safe, effective, and consistent approach to reduce pain during botulinum toxin type A treatment for glabellar and forehead lines. This technique may offer advantages over other methods used to alleviate the pain associated with these injections.

Botulinum Toxin-Induced Parotitis: A Postoperative Complication Following Masseter Muscle Injection.

Botulinum toxin (BTX) injection is a common treatment for bruxism, but there is no literature on potential salivary gland complications. This paper presents a case of acute parotitis in a 60-year-old female following BTX injections to the masseter muscle. This case highlights the possible salivary gland complications after injection of BTX into the masticatory muscles. An electronic search of PubMed and Embase databases was conducted to create a literature review in order to delve into the etiology behind the presented case and suggest potential preventive measures to avoid salivary gland complications. Thirty-one articles are reviewed and discussed. Currently, there is no consensus on the causes of the mentioned complication. However, various factors have been proposed, encompassing anatomical, physiological, biological, and physical aspects. Several methods have been recommended for the safe injection of BTX, which, along with better medical training and knowledge, are warranted to achieve predictable results.

OnabotulinumtoxinA as a promising treatment for primary trochlear headache: A retrospective case series.

OBJECTIVES: To report the efficacy of onabotulinumtoxinA (BoNTA) injections in relieving pain in patients with primary trochlear headache (PRTH). METHODS: Examination of medical records for patients diagnosed with PRTH according to the International Classification of Headache Disorders, 3rd edition criteria and treated with BoNTA. Data were collected for variables related to pain relief, duration of effectiveness, and adverse effects. RESULTS: Six patients were included in the study. All had previously undergone standard care interventions, including infiltrations or oral treatments, yet experienced treatment failure or symptom recurrence. All patients received 20 units of BoNTA, administered in the corrugator and procerus muscles. Subsequent to the BoNTA injections, all six patients reported substantial pain relief, with five achieving complete remission of symptoms. The analgesic effect persisted for a duration of 3 months. No adverse events were reported in any of the cases. CONCLUSIONS: Our case series presents the first evidence of the potential of BoNTA as a safe and effective treatment option for PRTH. From a clinical standpoint, having a safer alternative is of paramount significance for patients with limited treatment options, such as those with PRTH. Further research is warranted to validate these findings and explore the long-term efficacy of BoNTA in PRTH management.

Addressing limitations of single GON blockade treatment and repetitive intervention with GON block or onabotulinum toxin A in chronic migraine- part 2 of three men in a boat study.

This study investigated the effectiveness of three treatment interventions for managing migraine symptoms over a three-month assessment period: single greater occipital nerve block (GON), repetitive GON block, and single GON block combined with onabotulinium toxin A (BoNT-A) treatment. Significant improvements were observed across all treatment groups in various migraine-related parameters, including medication usage, frequency and severity of attacks, and subjective measures such as Headache Impact Test-6 scores and Pittsburgh Sleep Quality Index scores. Notably, all groups showed reductions in NSAID and triptan usage, total number of attacks with VAS>4, and number of headache days. However, slight differences in the magnitude of improvements were observed between the groups, with GON block combined with BoNT-A treatment demonstrating slightly greater reductions compared to single GON block treatment. Additionally, the integration of BoNT-A therapy alongside GON blockade appeared to confer supplementary benefits in migraine prophylaxis. These findings highlight the importance of implementing comprehensive treatment approaches to address various aspects of migraine management and improve patient outcomes.

A novel hybrid BonT-A and hyaluronic acid cannula-based technique for eyelid ptosis and periorbital rejuvenation.

BACKGROUND: Eyelid ptosis is characterized by an inferior displacement of the upper eyelid when the eye assumes its primary position. Besides its aesthetic implications, ptosis can also adversely affect visual acuity. OBJECTIVE: This study aimed to evaluate the simultaneous administration of IncobotulinumtoxinA (IncoBonTA) and hyaluronic acid effect in eyelid ptosis and ocular rejuvenation. METHODS: A novel, non-surgical technique for eyelid ptosis management involving IncoBonTA and hyaluronic acid the co-administration within a single syringe, and applied using a cannula. RESULTS: The dual action of IncoBonTA and hyaluronic acid in conjunction with the exact injection sites approaches improves overall aesthetic outcomes but also optimizes the restoration of eyelid functionality in palpebral ptosis. CONCLUSIONS: The functional balance achieved among the contributory muscles-primarily the orbicularis oculi (OO) and its antagonists, the frontal muscle and levator palpebrae superioris (LPS), yields to both, cosmetic and functional.

Botulinum neurotoxin type A responders among children with spastic cerebral palsy: Pattern-specific effects.

AIM: To identify short-term effects of botulinum neurotoxin type A (BoNT) injections on gait and clinical impairments, in children with spastic cerebral palsy (CP), based on baseline gait pattern-specific subgroups. METHOD: Short-term effects of BoNT injections in the medial hamstrings and gastrocnemius were defined in a retrospective convenience sample of 117 children with CP (median age: 6 years 4 months; GMFCS I/II/III: 70/31/16; unilateral/bilateral: 56/61) who had received gait analyses before and 2 months post-BoNT. First, baseline gait patterns were classified. Statistical and meaningful changes were calculated between pre- and post-BoNT lower limb sagittal plane kinematic waveforms, the gait profile score, and non-dimensional spatiotemporal parameters for the entire sample and for pattern-specific subgroups. These gait waveforms per CP subgroup at pre- and post-BoNT were also compared to typically developing gait and composite scores for spasticity, weakness, and selectivity were compared between the two conditions. RESULTS: Kinematic improvements post-BoNT were identified at the ankle and knee for the entire sample, and for subgroups with apparent equinus and jump gait. Limbs with baseline patterns of dropfoot and to a lesser extent true equinus showed clear improvements only at the ankle. In apparent equinus, jump gait, and dropfoot, spasticity improved post-BoNT, without leading to increased weakness or diminished selectivity. Compared to typical gait, knee and hip motion improved in the crouch gait subgroup post-BoNT. CONCLUSION: This comprehensive analysis highlighted the importance of investigating BoNT effects on gait and clinical impairments according to baseline gait patterns. These findings may help identify good treatment responders.

The Use of Botulinum Toxin Type A in Medically Refractory Pediatric Patients With Chronic Daily Headaches and Its Impact on the Quality of Life.

Background: Chronic migraine in children has been a challenging condition to treat, prompting the investigation of alternative therapies. This retrospective single-center chart review aimed to evaluate the efficacy and safety of Botox injections for managing chronic migraine in children. Methods: The study included children with chronic daily headaches and chronic migraine who were medically refractory to previous treatments at OSF Healthcare/Illinois Neurological Institute, Peoria, between 2015 and 2021. Botox injections were administered quarterly following a specific protocol. Data were obtained from electronic medical records by manual review. Results: Twenty-four patients met the inclusion criteria (median age 15.4 years, 87% female). Comorbidities included depression (41.6%) and sleep disturbances (33.2%). Prior to Botox treatment, patients had been tried on a median number of 5 (interquartile range [IQR] 4, 7) medications. Botox injections resulted in a significant reduction in headache frequency, with a mean difference (6 months vs pretreatment) in the Headache Impact Test (HIT 3) scores of -19.6 (95% CI -24.8, -14.3), P < .001, and mean difference in the Migraine Disability Assessment (MIDAS) scores of -50.8 (95% CI -62.6, -39.0, P < .001). Subjective improvements included mood enhancement (13/24, 54.2%) and improved concentration (12/24, 50%). Treatment-related side effects were reported by 5/24 (20%) of patients and were mostly mild to moderate. Conclusions: Botox injections offer a promising therapeutic option for managing chronic migraine in children who have not responded to traditional medications. Future controlled trials and long-term follow-up studies are needed to further evaluate Botox treatment's benefits and adverse effects in children with chronic migraine.

Trial Design for Mixed Urinary Incontinence: Midurethral Sling Versus Botulinum Toxin A.

IMPORTANCE: Mixed urinary incontinence (MUI) is common and can be challenging to manage. OBJECTIVES: We present the protocol design and rationale of a trial comparing the efficacy of 2 procedures for the treatment of women with MUI refractory to oral treatment. The Midurethral sling versus Botulinum toxin A ( MUSA) trial compares the efficacy of intradetrusor injection of 100 U of onabotulinimtoxinA (an office-based procedure directed at the urgency component) versus midurethral sling (MUS) placement (a surgical procedure directed at the stress component). STUDY DESIGN: The MUSA is a multicenter, randomized trial of women with MUI electing to undergo procedural treatment for MUI at 7 clinical centers in the NICHD Pelvic Floor Disorders Network. Participants are randomized to either onabotulinumtoxinA 100 U or MUS. OnabotulinimtoxinA recipients may receive an additional injection between 3 and 6 months. Participants may receive additional treatment (including crossover to the alternative study intervention) between 6 and 12 months. The primary outcome is change from baseline in Urogenital Distress Inventory (UDI) at 6 months. Secondary outcomes include change in UDI at 3 and 12 months, irritative and stress subscores of the UDI, urinary incontinence episodes, predictors of poor treatment response, quality of life and global impression outcomes, adverse events, use of additional treatments, and cost effectiveness. RESULTS: Recruitment and randomization of 150 participants is complete and participants are currently in the follow-up phase. CONCLUSIONS: This trial will provide information to guide care for women with MUI refractory to oral treatment who seek surgical treatment with either onabotulinumtoxinA or MUS.

Efficacy and safety of botulinum toxin for rosacea with positive impact on quality of life and self-esteem.

BACKGROUND: Rosacea is a prevalent chronic inflammatory skin disease with a multifactorial pathophysiology. It compromises several skin structures, including the proliferation and dilation of dermal blood vessels, primarily in the central areas of the face, accompanied by significant psychosocial impairment, leading to reduced quality of life (QoL) and self-esteem. There are consensus guidelines for its treatment, but few options for the erythema. This study hypothesizes that treating rosacea skin lesions with botulinum toxin (BTX) could improve signs and symptoms, resulting in enhanced QoL and self-esteem. METHODS: This interventional, open, uncontrolled, and prospective study, conducted at a single center, included 33 individuals diagnosed with rosacea, treated with standard therapeutic options according to the rosacea subtype plus superficial injections of BTX, and followed up for 90 days. Botulinum toxin injections were applied on Days 1 and 14. Clinical features and side effects were assessed at each visit; QoL, self-esteem, and medication adherence questionnaires were administered on Days 1 and 90. RESULTS: Treatment with BTX yielded improvement in the clinical signs of rosacea, registered by the investigators, and reported by 94% of the participants. Improved QoL scores (P < 0.05) and a notable increase in self-esteem scores (P < 0.001) were demonstrated. Rare adverse events were observed. CONCLUSIONS: The utilization of BTX superficial injections in patients with rosacea was safe and effective, improving the clinical appearance of the lesions. Despite some limitations, to our knowledge, this is the first study that showed the positive impact of this treatment modality on both QoL and self-esteem.

Advanced Injection of Botulinum Toxin in the Nasal Muscles: A Novel Dynamic Change in Facial Expression.

BACKGROUND: Among the nasal muscles, the levator labii superior alaeque nasi (LLSAN) acts as a transitional muscle that conjugates with other nasal and perinasal muscles. Thus, when treating the nasal region with Botulinum toxin (BTX), it is important to understand local nasal muscular dynamics and how they can influence the muscular dynamics of the entire face. METHODS: This is a retrospective analysis of cases treated by an injection pattern encompassing the face, including nasal muscles. Photographs were taken at rest and during motion (frontal and oblique views), before and after treatment. RESULTS: A total of 227 patients have been treated in the last 18 months with the following results: eyebrow tail lifting, softness of crow's feet, improvement of the drooping of the tip of the nose, and shortening of the lip philtrum when smiling. We present cases illustrating the use of this approach. CONCLUSIONS: Treating the facial muscles globally (including the frontal, corrugators, procerus, orbicularis oculi, platysma, DAO, and nasal muscles) can improve the smile and facial expressions. This is believed to occur because the elevated portion of the upper lip muscle becomes stronger as the nasal part of the LLSAN is paralyzed. LEVEL OF EVIDENCE IV: 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 .

Trial of Botulinum Toxin for Isolated or Essential Head Tremor.

BACKGROUND: Local injections of botulinum toxin type A have been used to treat essential head tremor but have not been extensively studied in randomized trials. METHODS: In a multicenter, double-blind, randomized trial, we assigned, in a 1:1 ratio, adult patients with essential or isolated head tremor to receive botulinum toxin type A or placebo. Botulinum toxin or placebo was injected under electromyographic guidance into each splenius capitis muscle on the day of randomization (day 0) and during week 12. The primary outcome was improvement by at least 2 points on the Clinical Global Impression of Change (CGI) scale at week 6 after the second injection (week 18 after randomization). The CGI scale was used to record the patient's assessment of the degree of improvement or worsening of head tremor since baseline; scores range from 3 (very much improved) to -3 (very much worse). Secondary outcomes included changes in tremor characteristics from baseline to weeks 6, 12, and 24. RESULTS: A total of 120 patients were enrolled; 3 patients were excluded during screening, and 117 patients were randomly assigned to receive botulinum toxin (62 patients) or placebo (55 patients) and were included in the intention-to-treat analysis. Twelve patients in the botulinum toxin group and 2 patients in the placebo group did not receive injections during week 12. The primary outcome - improvement by at least 2 points on the CGI scale at week 18 - was met by 31% of the patients in the botulinum toxin group as compared with 9% of those in the placebo group (relative risk, 3.37; 95% confidence interval, 1.35 to 8.42; P = 0.009). Analyses of secondary outcomes at 6 and 12 weeks but not at 24 weeks were generally supportive of the primary-outcome analysis. Adverse events occurred in approximately half the patients in the botulinum toxin group and included head and neck pain, posterior cervical weakness, and dysphagia. CONCLUSIONS: Injection of botulinum toxin into each splenius capitis muscle on day 0 and during week 12 was more effective than placebo in reducing the severity of isolated or essential head tremor at 18 weeks but not at 24 weeks, when the effects of injection might be expected to wane, and was associated with adverse events. (Funded by the French Ministry of Health; Btx-HT ClinicalTrials.gov number, NCT02555982.).

Botulinum toxin A dissolving microneedles for hyperhidrosis treatment: design, formulation and in vivo evaluation.

Multiple periodic injections of botulinum toxin A (BTX-A) are the standard treatment of hyperhidrosis which causes excessive sweating. However, BTX-A injections can create problems, including incorrect and painful injections, the risk of drug entry into the bloodstream, the need for medical expertise, and waste disposal problems. New drug delivery systems can substantially reduce these problems. Transdermal delivery is an effective alternative to conventional BTX-A injections. However, BTX-A's large molecular size and susceptibility to degradation complicate transdermal delivery. Dissolving microneedle patches (DMNPs) encapsulated with BTX-A (BTX-A/DMNPs) are a promising solution that can penetrate the dermis painlessly and provide localized translocation of BTX-A. In this study, using high-precision 3D laser lithography and subsequent molding, DMNPs were prepared based on a combination of biocompatible polyvinylpyrrolidone and hyaluronic acid polymers to deliver BTX-A with ultra-sharp needle tips of 1.5 ± 0.5 µm. Mechanical, morphological and histological assessments of the prepared DMNPs were performed to optimize their physicochemical properties. Furthermore, the BTX-A release and diffusion kinetics across the skin layers were investigated. A COMSOL simulation was conducted to study the diffusion process. The primary stability analysis reported significant stability for three months. Finally, the functionality of the BTX-A/DMNPs for the suppression of sweat glands was confirmed on the hyperhidrosis mouse footpad, which drastically reduced sweat gland activity. The results demonstrate that these engineered DMNPs can be an effective, painless, inexpensive alternative to hypodermic injections when treating hyperhidrosis.