Botulinum Toxin Type A Injection Research Articles

Modified botulinum toxin type A injections improve symptoms associated with interstitial cystitis/bladder pain syndrome in women: a retrospective cohort study.

To investigate the efficacy and safety of modified botulinum toxin type A (BoNT-A) injections (with additional periurethral injection [PUI] of BoNT-A) for the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS). This single-center, retrospective cohort study included 52 adult female patients with IC/BPS, with 24 patients receiving conventional BoNT-A injections and 28 receiving modified BoNT-A injections. The primary outcome measure was patient-reported global response assessment (GRA). Secondary outcomes included daytime frequency, nocturia, number of urinary urgency episodes in the voiding diary, pain visual analog score, O'Leary-Sant Interstitial Cystitis Symptom Index and Interstitial Cystitis Problem Index, pelvic pain and urgency/frequency scores, risk factors for recurrence, and postoperative recurrence-free time. The median duration of follow-up was 16.0 months (interquartile range 11.75-21 months). Patients who underwent modified BoNT-A injections showed significant improvement in postoperative GRA, symptom questionnaires, and pain assessment compared with those who underwent conventional surgery. A statistically significant difference was observed between the two groups in terms of recurrence-free time (12.5 vs. 18.0 months, P=0.02). Subgroup analysis suggested that additional PUI of BoNT-A was more effective in patients with combined severe periurethral pain. No serious complications occurred in both groups, and all minor postoperative complications were temporary. Modified BoNT-A injection is an effective treatment for IC/BPS that significantly reduces pain and improves voiding symptoms. It is particularly effective in patients with combined periurethral pain. In such patients, PUI of BoNT-A should be added to the routine intravesical injection of BoNT-A.

Clinical Application of Botulinum Toxin A on Nasal Reconstruction with Expanded Forehead Flap for Asian Patients.

Because of its unique advantages, frontal expansion has become a common tool for Asian nasal reconstruction, but it has the limitations of prolonging the duration and pain in the expansion area. Based on the fact that the denervation effect of botulinum toxin type A (BTX-A) has been widely used in the reconstruction of superficial organs, we hypothesized that BTX-A would shorten the length of nasal reconstruction sequence and alleviate the discomfort of patients. A comparative retrospective study was conducted of consecutive patients underwent sequential treatment of nasal reconstruction between June 2010 and July 2012. Data on demographics, BTX-A injection plan and expansion duration were collected and analyzed. Phased pain intensity outcomes were evaluated by visual analogue scale (VAS). Photographs were collected during the follow-up period. Thirty patients were enrolled in the study; 15 (50%) with and 15 (50%) without BTX-A pre-injection. Demographic data were homogeneous. The duration of the observation group (BTX-A pretreated) (133.87 ± 13.64 days) was significantly shortened versus the control group (164.27 ± 14.08 days, P<0.001). At the initial stage, no significant difference was found in the VAS scores (P=0.64). At the medium stage, the VAS score of the observation group (2.07 ± 0.80) was significantly lower than the control group (3.00 ± 0.53, P<0.01). At the terminal stage, the VAS score of the observation group (1.93 ± 0.59) was significantly lower than the control group (2.73 ± 0.70) but with a narrower disparity. Pre-injection of BTX-A is effective in shortening the duration of the expansion phase, as well as relieving the pain associated with expansion. The journal asks authors to assign a level of evidence to each article. For a complete description of Evidence-Based Medicine ratings, see the Table of Contents or the online Instructions for Authors at www.springer.com/00266 .

Botulinum Toxin Injections for Psychiatric Disorders: A Systematic Review of the Clinical Trial Landscape.

Botulinum toxin type A (BONT-A) has shown promise in improving the mood-related symptoms of psychiatric disorders by targeting muscles linked to the expression of negative emotions. We conducted a systematic review of past and ongoing efficacy trials of BONT-A therapy for psychiatric disorders to identify relevant trends in the field and discuss the refinement of therapeutic techniques. A comprehensive search for published clinical trials using BONT-A injections for psychiatric disorders was performed on 4 May 2023 through OVID databases (MEDLINE, Embase, APA PsycINFO). Unpublished clinical trials were searched through the ClinicalTrials.gov and International Clinical Trial Registry Platform public registries. The risk of bias was assessed using the JBI Critical Appraisal tools for use in systematic reviews. We identified 21 studies (17 published, 4 unpublished clinical trials) involving 471 patients. The studies focused on evaluating the efficacy of BONT-A for major depressive, borderline personality, social anxiety, and bipolar disorders. BONT-A was most commonly injected into the glabellar area, with an average dose ranging between 37.75 U and 44.5 U in published studies and between 32.7 U and 41.3 U in unpublished trials. The results indicated significant symptom reductions across all the studied psychiatric conditions, with mild adverse effects. Thus, BONT-A appears to be safe and well-tolerated for psychiatric disorders of negative affectivity. However, despite the clinical focus, there was a noted shortage of biomarker-related assessments. Future studies should focus on pursuing mechanistic explorations of BONT-A effects at the neurobiological level.

Botulinum toxin type A inhibits M1 macrophage polarization by deactivation of JAK2/STAT1 and IκB/NFκB pathway and contributes to scar alleviation in aseptic skin wound healing

The non-neuronal and non-muscular effects of botulinum toxin type A (BTXA) on scar reduction has been discovered. This study was designed to investigate the effects of BTXA on macrophages polarization during the early stage of skin repair. A skin defect model was established on the dorsal skin of SD rats. BTXA was intracutaneous injected into the edge of wound immediately as the model was established. Histological examinations were performed on scar samples. Raw 264.7 was selected as the cell model of recruited circulating macrophages, and was induced for M1 polarization by LPS. Identify the signaling pathways that primarily regulated M1 polarization and respond to BTXA treatment. Application of BTXA at early stage of injury significantly reduced the scar diameter without delaying wound closure. BTXA treatment improved fiber proliferation and arrangement, and inhibited angiogenesis in scar granular tissue. The number of M1 macrophages and the levels of pro-inflammation were decreased after treated with BTXA in scar tissues. LPS activated JAK2/STAT1 and IκB/NFκB pathways were downregulated by BTXA, as well as LPS induced M1 polarization. At early stage of skin wound healing, injection of BTXA effectively reduced the number of M1 macrophages and the levels of pro-inflammatory mediators which contributes to scar alleviation. BTXA resisted the M1 polarization of macrophages induced by LPS via deactivating the JAK2/STAT1 and IκB/NFκB pathways.

Efficacy and Safety of Botulinum Toxin Type A in the Treatment of Trigeminal Neuralgia: An update systematic review with meta-analyses.

This review aims to analyze the current data for the use of botulinum toxin type A (BTX-A) in the treatment of trigeminal neuralgia (TN) and highlight the evidence for its efficacy and safety. Pain management in patients with TN is challenging, as facial pain often does not respond well to conventional therapies. BTX-A has been suggested as a potential treatment option, but there is limited evidence regarding its long-term efficacy. A comprehensive search was conducted in various databases (PubMed, Scopus, Embase, ClinicalTrials and Cochrane Library) to identify clinical studies evaluating the use of BTX-A in TN until October 2023. Randomized controlled trials, single-arm studies, and stratified studies were included in the analysis. The mean difference (MD), effect size (ES), and 95% confidence interval (CI) were estimated for visual analogue scale (VAS) scores, pain attack frequency and the proportion of responders. The analysis included 23 studies, including four randomized controlled trials, fourteen single-arm studies, and five stratified studies. In the randomized controlled trials, BTX-A was found to significantly reduce mean VAS scores compared to baseline (ES: -4.05; 95% CI: -6.13, -1.97; P=0.002). In nineteen non-RCTs, the pooled single-arm analysis revealed that BTX-A decreased VAS scores (ES: -5.19, 95% CI: -6.05, -4.33, P<0.001) and pain attack frequency (ES: -17.85, 95% CI: -23.36, -12.34, P<0.001) from baseline to the end of follow-up. The overall proportion of responders to BTX-A treatment was also significant (95%CI: 0.653, 0.761, P=0.003). Current evidence indicated BTX-A injection is an effective and safety option for patients with refractory TN or not responding to medical or surgical management. However, more high-quality studies are needed to further confirm its efficacy.

Deciphering Depressor Anguli Oris for Lower Face Rejuvenation: A Prospective Ultrasound-Based Investigation.

The depressor anguli oris muscle (DAO) is a pivotal treatment target in creation of harmonic jawline. However, evidence of its live morphology remains scarce. This study aimed to reevaluate DAO by a facile ultrasound analysis and hereby guide safer and more effective botulinum toxin type A (BTX-A) injection. A prospective ultrasound assessment was conducted in 41 patients. Morphology of DAO and its relative position with neighboring structures were appraised at the ubiquitous facial landmark, labiomandibular fold (LMF). Three-dimensional images were captured before and after receiving BTX-A injection based on sonographic evidence. The skin-to-muscle depths of DAO on average (measured from the medial to lateral border) were 5.26, 5.61, and 8.42 mm. DAO becomes thinner and wider from zone 1 to 3 (p < 0.001). Overlapping lengths between DAO and DLI increased from zone 1 to 3: 4.74, 9.68, 14.54 mm (p < 0.001). The medial border of DAO was located at 4.33, 6.12, 8.90 mm medial to LMF (zone 1-3), and no muscle fibers of DAO was observed at zone 1 and 2 in near one-third of patients. Mouth corner downturn angle improvement upon receiving BTX-A injection at zone 2 and 3 were 88.3%, 32.3%, and 14.7% for the neutral, maximum smile, and down-pulling mouth corner expressions. This work established an informative ultrasound portrait of the DAO and structures in the perioral region, which suggests LMF as a convenient landmark to locate DAO. Injections at the middle and lower thirds of LMF at a 4-5 mm depth is recommended.

Interventions to prevent postoperative atrial fibrillation in Dutch cardiothoracic centres: asurvey study.

Postoperative atrial fibrillation (POAF) is acommon phenomenon following cardiac surgery. In this study, we assessed current preventive strategies used by Dutch cardiothoracic centres, identified common views on this matter and related these to international guidelines. We developed an online questionnaire and sent it to all cardiothoracic surgery centres in the Netherlands. The questionnaire concerned the management of POAF and the use of pharmaceutical therapies (beta-blockers and calcium antagonists) and non-pharmaceutical methods (posterior left pericardiotomy, pericardial flushing and epicardial botulinum toxin typeA injections). Usage of electrical cardioversions, anticoagulants and left atrial appendage closure were also enquired. Of the 15centres, 14(93%) responded to the survey and 13reported aPOAF incidence, ranging from 20to 30%. Of these 14centres, 6prescribed preoperative AF prophylaxis to their patients, of which non-sotalol beta-blockers were prescribed most commonly (57%). Postoperative medication was administered by all centres and included non-sotalol beta-blockers (38%), sotalol (24%), digoxin (14%), calcium antagonists (13%) and amiodarone (10%). Only 2centres used posterior left pericardiotomy or pericardial flushing as surgical manoeuvres to prevent POAF. Moreover, respondents expressed the need for guidance on anticoagulant use. Despite the use of various preventive strategies, the reported incidence of POAF was similar in Dutch cardiothoracic centres. This study highlights limited use of prophylactic amiodarone and colchicine, despite recommendations by numerous guidelines, and restricted implementation of surgical strategies to prevent POAF.

Hyperdiluted Botulinum Toxin and Intense Pulsed Light Treatment: A Case Series to Illustrate a Novel Protocol for Hypertrophic Scar Reduction.

Hypertrophic scars can have significant and far-reaching effects on patients that range from itching to creating difficulty with mobility, all of which can negatively impact the individual's quality of life. A recent study showed that many patients with recent scars report pain, burning, pruritus, erythema, in combination with psychological difficulties that impact bodily movement, choice of clothing, and participation in leisure activities. Botulinum toxin Type A (BoNTA) and intense pulsed light (IPL) have shown promise in treating such scars. We propose a novel treatment protocol involving a 4-week intervention with hyperdiluted BoNTA injections and supplemental treatment with IPL for erythema, and a 6-month scar scale assessment and photographic documentation that occurs before and 6 months after treatment. We report four cases where using hyperdiluted BoNTA, either alone or in conjunction with IPL, substantially reduced scar size, improved overall scar appearance, and diminished erythema in areas on the face and the breasts. Although this report suggests that a schedule of alternating treatments with BoNTA and IPL may be beneficial in reducing scar size and enhancing appearance, further research is necessary to better understand the most effective dosages, the relationship between BoNTA and IPL, and the optimal management of scarring.

Unlocking tracheoesophageal speech from pharyngoesophageal spasm: preliminary results of a videofluoroscopic-guided botulinum toxin A injection technique.

The tracheoesophageal puncture for the voice prosthesis (VP) placement is the recognized gold standard in post-laryngectomy voice rehabilitation. Despite the development of specific intraoperative techniques, a subset of patients will suffer from poor functional outcomes due to pharyngoesophageal spasms (PES). This paper evaluates the functional outcomes after transcutaneous botulinum toxin type A (BTX-A) infiltration for PES with a videofluoroscopy-guided technique. Since 2022, eight consecutive patients with VP and affected by PES were treated with BTX-A injection by a standard videofluoroscopic guided technique at the European Institute of Oncology, IRCCS (IEO) in Milan. A lidocaine test was performed pre-operatively to evaluate the potential effect of chemical neurectomy. All patients with positive lidocaine tests were injected with 50IU of BTX-A (Allergan, Irvine, CA) according to the sites marked during the videofluoroscopy. Reported symptoms (VHI, SECEL), perceptual (INFVo), aerodynamic (MPT) and manometric parameters were collected before and after treatment. In all cases, BTX-A was performed as an outpatient procedure without complications. For seven patients, only one BTX-A injection was needed, while one patient required a re-injection. Subjective and perceptive improvement after BTX-A was significant for VHI, SECEL and INFVo. MPT showed significant improvement after a chemical neurectomy. After a mean follow-up of 6months, all patients maintained a good TES quality. The videofluoroscopic guided BTX-A injection of the pharyngoesophageal tract showed to be a feasible and reproducible technique in all cases. The pharyngoesophageal videofluoroscopy allows defining of patients' anatomical landmarks that help the surgeon to perform a homogeneous injection, empowered by post-injection massage.

Evaluation of Botulinum Toxin Applications in a Tertiary Cosmetic Department

Aim: Botulinum toxin type A (BTX-A) treatment for facial rejuvenation has&#x0D; been started to used widely and become the most common aesthetic procedure. The aim in&#x0D; this study to evaluate the patients features and outcomes who had Onabotulinumtoxin A.&#x0D; Material and Method: The data of the BTX-A patient’s gender, age, occupation, history of cosmetic&#x0D; procedures, history of disease, doses of the first and control injections, complications and&#x0D; expectations from the therapy collected from the medical records. The patients were divided&#x0D; into two groups as under the age of 45 and age of 45 and older. These groups were compared&#x0D; with each other in terms of mentioned variables.&#x0D; Results: A total of 200 patients included in this study. The mean botulinum toxin dose was&#x0D; 33.7 units and the mean control dose was 4.5 units. Three (1.5%) of the patients developed a&#x0D; complication, all of them were eyelid ptosis. Most common expectation from the toxin&#x0D; injection was to look more young (69%) and vigorous (75.5%). There were no significant&#x0D; difference between the under the age of 45 and 45 and older group in terms of total BTX-A&#x0D; dose and control dose and complication rate (p=0.8, p=0.5, p=0.6). Expectation of looking&#x0D; less angry and less saggy were significantly higher in the 45 year and older group (p=0.02,&#x0D; p=0.02).&#x0D; Conclusion: It is important to evaluate the patient’s gender, age and expectations from the&#x0D; botulinum toxin injection to get the highest efficiency from BTX-A injection.

Outcome of delayed versus immediate casting on spasticity of lower limb muscles in cerebral palsy post-botulinum toxin injection

Background: Botulinum toxin type A (BTX-A) is widely used to treat spasticity in children. The optimal strategy for the combined treatment of casting and BTX-A injections is not known. This prospective study is conducted to know the functional outcome of immediate versus delayed casting post-BTX-A injection in children with cerebral palsy (CP). Aims and Objectives: The aim of this study is to compare delayed versus immediate casting as an adjunct to botulinum toxin therapy for spasticity of lower limb muscles in CP. The objectives of the study are to test the hypothesis that delayed casting is superior to immediate casting post-botulinum toxin injection and to know the feasibility of using the Edinburgh visual gait score (EVGS) as a single qualitative and quantitative outcome measure. Materials and Methods: A prospective study is conducted to compare immediate casting with delayed casting post-botulinum toxin injection to spastic lower limb muscles in patients with CP from July 2018 to February 2019. Inclusion criteria: A diagnosis of CP with associated spastic monoplegia, diplegia, or hemiplegia with aided or unaided ambulation. Exclusion criteria: History of orthopedic surgery in the preceding 12 months; selective dorsal rhizotomy; mixed CP; ataxia; athetosis; non-ambulatory subjects. Results: The botulinum toxin injection + delayed POP casting group fared better in terms of clinical and functional outcome (as shown by improved EVGS scores) in our study. Conclusion: There is a clear benefit in delaying casting after the injection of Botulinum toxin in the recurrence of spasticity.

[Rehabilitation of patients with facial nerve neuropathy in cases of increased muscle tone on the healthy side of the face].

To evaluate the effectiveness of physical rehabilitation (PR) and injections of botulinum toxin type A (BTA) in the correction of muscles hypertonicity ty of the healthy side of the face or its prevention in patients with facial nerve neuropathy (FNN). One hundred and forty-six patients with FNN of various etiologies with muscles hypertonicity of the healthy side or the risk of its development were studied. The term of treatment was 33 [10; 99] days. There are 88 women and 58 men aged 42 [34; 56] years. Diagnosis included clinical examination and stimulation electroneuromyography (ENMG, n=113; 77.4%) with assessment of M-wave amplitude asymmetry. All patients were prescribed a standard PR complex, in addition - relaxation of the muscles of the healthy side by injections of BTA (Incobotulinumtoxin A) - BTA group (n=38) or by special PR techniques - physiotherapy group (n=108). In both groups, patients were comparable in age, sex and severity of FNN at clinical assessment. But objectively, in the BTA group there were more symptomatic forms (63.2% vs 43.5%; p=0.038), cases of M-wave amplitude asymmetry over 90% in ≥2 branches (52.6% vs 18.5%; p=0.032). Displacement of the face midline was a factor limiting recovery (68.4% and 62%; χ2=0.495; p=0.482) in two groups. With amplitude asymmetry of more than 90% in ≥2 branches (a predictor of the risk of unfavorable outcome), a favorable outcome occurred more often in the BTA group (80% versus 45%; χ2=5.227; p=0.023). In case of amplitude asymmetry of less than 90% in all branches, a favorable outcome was observed in two groups. Indications for botulinum therapy in patients with FNN are deep prosoparesis or prosoplegia, muscles hypertonicity of the healthy side, displacement of the face midline, ENMG predictors of the risk of unfavorable outcome. PR is an effective method of prevention in patients with a favorable prognosis of outcome or treatment of mild forms.

Outcome of endo-anal ultrasound-guided injection of botulinum toxin type-A therapy in puborectalis muscle in patients with anismus

Background Anismus is a functional disorder characterized by dyssynergia and incoordination of pelvic floor muscular contractions at defecation. Despite normal propulsive power used when attempting to defecate, a hypertonic pelvic floor dysfunction results in nonrelaxation or even paradoxical contraction of puborectalis muscle, resulting in failure to straighten the anorectal angle, hence impaired stool evacuation. This study aims at evaluating the outcome of injection of botulinum toxin type-A (BTX-A) in puborectalis muscle in patients with anismus. Patients and methods The study included 50 patients who were presented with symptoms of obstructed defecation (OD) and were diagnosed as anismus and failed conservative treatment and biofeedback training. Ultrasound-guided BTX-A injections into puborectalis muscle were done. All patients were followed up for 6 months for OD symptoms and manometric findings. Results The current study included 50 patients with a mean age of 36.6±11.9 years presented with anismus for a mean duration of 6.8±2.64 months. There was a statistically significant improvement in the Longo score of OD at 1, 3, and 6 months when compared with the initial values (P&lt;0.001), while there was no statistically significant difference noticed in the defecation frequency at 3 and 6 months when compared with the initial records. There was a statistically significant decrease in both resting and squeeze pressures after 3 and 6 months when compared with the initial records (P&lt;0.001). The overall satisfaction significantly increased to 68 and 64% after 3 and 6 months, respectively, when compared with 0% satisfaction reported at the initial assessment. Conclusion According to the current results, injection of BTX-A therapy in puborectalis muscle in patients with anismus is assumed to be effective for short term with good overall satisfaction.

Technical aspects of performing laparoscopic hernioplasty in the treatment of large ventral hernias

Laparoscopic hernioplasty is a promising treatment option for ventral hernias. The technique of intraperitoneal mesh placement (IPOM) is the most extensively studied and widely used for the closure of a defect during laparoscopic hernia repair. The large size of the defect and its diameter exceeding 10 cm are limiting factors in the selection of minimally invasive techniques for hernioplasty. The process of suturing the hernia prior to the placement of the mesh, as well as the technique used to fix it, show controversial results in terms of postoperative quality of life and the risk of recurrence. Objective —  to study the technical aspects of performing laparoscopic prosthetic hernioplasty using the IРOM technique for the surgical treatment of patients with large primary ventral hernias (PVH) and postoperative incisional ventral hernias (IVH). Materials and methods. The study included a total of 84 patients who were undergoing treatment at the clinical base of the Department of General Surgery No. 2 of Bogomolets National Medical University. There were 51 (60.7%) women and 33 (39.3%) men. The average age was 58.73±10.9 years. All patients were operated on for large ventral hernias. Of these, 52 (61.9%) patients had surgery for PVH (umbilical hernia, line alba hernia), while 32 (38.1%) — for IVH. In 56 (66.7) patients, the width of the hernia defect was &gt; 10 cm, of which 24 (28.6%) patients had PVH. In these patients, 4 weeks before surgery, 100 units of botulinum toxin type A (BTA) were injected intramuscularly into the muscles of the anterior abdominal wall in accordance with the methodology developed in the clinic. All patients underwent laparoscopic prosthetic hernioplasty with IPOM under general combined anesthesia. Control examinations of patients were carried out 2 weeks, 1 month, 6 months, and 1 year after the operation. Results. All patients underwent IPOM, while 38 (45.2%) patients underwent laparoscopic IPOM with suturing of the defect, 36 (42.9%) patients underwent IPOM with suturing the hernia defect before placing the mesh (IPOM+), and 10 (11.9%) patients underwent IPOM without suturing the defect. 32 (38.1%) patients were aged 65 years, including 10 patients who did not undergo suturing of the defect before the mesh placement. After the injection of BTA, the number of patients with a defect width of ≥10 cm decreased to 15 (17.8%). All of these patients had a defect smaller than 15 cm. The average duration of surgery for IPOM without hernia suturing was 60.00±11.30 min; for IPOM with laparoscopic suturing, it was 108.16±40.29 min; for IPOM+ with open suturing, it was152.08±40.64 min. The average length of stay in the hospital after surgery was higher in the group of patients who underwent hernioplasty using the IPOM+ technique compared to other techniques (p &lt;0.001). In the early postoperative period, the complication rate was 13.1%; all cases were classified as minor (Grade I, II, IIIa) according to the Clavien–Dindo classification. Conclusions. Laparoscopic hernioplasty using the IPOM is a safe and reliable method for large ventral hernia repair. Administering preoperative BTA injections enables the reduction of the defect and facilitates the execution of laparoscopic hernioplasty in patients with a primary hernia size of ≥10 cm.  

Robotic gait training and botulinum toxin injection improve gait in the chronic post-stroke phase: A randomized controlled trial

BackgroundImproving walking ability is one of the main goals of rehabilitation after stroke. When lower limb spasticity increases walking difficulty, botulinum toxin type A (BTx-A) injections can be combined with non-pharmacologic interventions such as intensive rehabilitation using a robotic approach. To the best of our knowledge, no comparisons have been made between the efficacy of robotic gait training and conventional physical therapy in combination with BTx-A injections. ObjectiveTo conduct a randomized controlled trial to compare the efficacy on gait of robotic gait training versus conventional physiotherapy after BTx-A injection into the spastic triceps surae in people after stroke. MethodThirty-three participants in the chronic stroke phase with triceps surae spasticity inducing gait impairment were included. After BTx-A injection, participants were randomized into 2 groups. Group A underwent robotic gait training (Lokomat®) for 2 weeks, followed by conventional physiotherapy for 2 weeks (n = 15) and Group B underwent the same treatment in reverse order (n = 18). The efficacy of these methods was tested using the 6-minute walk test (6MWT), comparing post-test 1 and post-test 2 with the pre-test. ResultsAfter the first period, the 6MWT increased significantly more in Group A than in Group B: the mean difference between the interventions was 33 m (95%CI 9; 58 p = 0.007; g = 0.95), in favor of Group A; after the second period, the 6MWT increased in both groups, but the 30 m difference between the groups still remained (95%CI 5; 55 p = 0.019; g = 0.73). ConclusionTwo weeks of robotic gait training performed 2 weeks after BTx-A injections improved walking performance more than conventional physiotherapy. Large-scale studies are now required on the timing of robotic rehabilitation after BTx-A injection.

Intrarectal injections of botulinum toxin versus placebo for the treatment of urge faecal incontinence in adults (FI-Toxin): a double-blind, multicentre, randomised, controlled phase 3 study

Non-randomised studies assessing intrarectal botulinum toxin type A (BoNTA) injections for faecal incontinence are promising. We aimed to evaluate the efficacy of BoNTA for the treatment of faecal incontinence in a randomised study. In this randomised, double-blind, placebo-controlled study, we included adult patients who had at least one urgency or faecal incontinence episode per week for at least 3 months and who had experienced a failure of conservative or surgical treatment from eight French specialist hospital units with the skills to manage patients with faecal incontinence. Patients were randomly assigned (1:1) by a central web form to receive intrarectal submucosal injections of either 200 units of BoNTA (Botox; Allergan, Irvine, CA, USA; BoNTA group) or an equivalent volume of saline (placebo group), stratified by Cleveland Clinic Severity scores (CCS score; ≥12 or <12). Patients, investigators, study site staff, and sponsor personnel were masked to treatment allocation up to the 6-month visit. The primary endpoint was the number of episodes of faecal incontinence and urgency per day assessed using 21-day patient bowel diaries 3 months after the treatment. The primary analysis was performed using a modified intention-to-treat (mITT) approach (ie, in all the randomised patients who had received a treatment) with adjustment for baseline faecal incontinence and urgency episodes. After the final data collection at 6 months after injections, patients were unmasked and offered the BoNTA treatment if they were in the placebo group (rescue therapy) without masking, with an additional 6 months of safety follow-up. This trial is registered with ClinicalTrials.gov, number NCT02414425. Between Nov 25, 2015, and Nov 25, 2020, we randomly assigned 200 patients to receive either BoNTA (n=100) or placebo (n=100) injections. Due to withdrawals before the injections, 96 patients were included in the BoNTA group and 95 patients were included in the placebo group (mITT analysis). The mean number of faecal incontinence and urgency episodes per day in the BoNTA group decreased from 1·9 (SD 2·2) at baseline to 0·8 (1·8) at 3 months after the injections, and from 1·4 (1·1) to 1·0 (1·0) in the placebo group, with a baseline-adjusted mean group difference at 3 months estimated at -0·51 (95% CI -0·80 to -0·21, p=0·0008). No serious treatment-related adverse events were reported in the trial. The most frequently reported non-serious adverse event (treatment related or not) following the BoNTA or placebo injections was constipation (reported in 68 [40%] of 169 patients who received the BoNTA injections and 38 [40%] of 95 patients who received placebo injections). BoNTA injections are an efficacious treatment for urge faecal incontinence. Further research will define the optimum selection criteria, dose, site of injection, re-injection frequency, and long-term results. General Direction of Healthcare (French Ministry of Health).

Pain Management Strategies for Botulinum Toxin Type A Injections in Children: A Comprehensive National Survey and Procedural Protocol.

Botulinum toxin type Ainjections are a first-line treatment forspasticity in children. Our purpose is to delineate the national landscape concerning pain management for botulinum toxin type A injections in pediatric patients and to formulate a protocol grounded in current scientific evidence. We conducted a nationwide survey targeting physical medicine and rehabilitation specialists performing botulinum toxin type A injections for focal spasticity in children in Portugal. We conducted a literature review to compare the survey results with clinical guidelines, good practice manuals, and protocols published in the literature. Finally, we developed a procedural protocol for pain management in botulinum toxin procedures. The survey was completed by 17 out of 18 identified specialists. All but one use some form of periprocedural analgesia. Five do not use any type of sedation. The majority do not assess pain during the procedures. From the reviewed articles, we obtained 23 articles, 19 of which provided data for detailed analysis. A prevailing concern centers around pain management during botulinum toxin procedures in children. Nevertheless, a distinct absence of uniformity persists in appraising and managing procedure-related pain. This notion is further underscored by the marked heterogeneity and paucity of published literature within this realm. The systematic implementation of a procedural protocol thus becomes highly crucial.

Unilateral injection of botulinum toxin type A into the masseter muscle induces mandibular asymmetry in adolescent rats by suppressing the angular process growth

Mandibular asymmetry has negative impacts on maxillofacial aesthetics and psychological well-being. This study investigated the effects of unilateral injection of botulinum toxin type A (BTX-A) into the masseter muscle on mandibular symmetry. Forty Wistar rats (4-week-old) were divided into 4 groups (n= 10): control, group 1 (1U BTX-A), group 2 (3U BTX-A), and group 3 (1U BTX-A for 3 times). BTX-A was injected into the right masseter of treatment groups. Cone-beam computerized tomography scans were taken before the injection and then at 2 weeks, 4 weeks, and 6 weeks after injection. Histologic and immunohistochemical staining were done for the condylar cartilage. RNA sequencing and quantitative reverse transcription polymerase chain reaction were used to detect gene expression in the angular process. In Groups 2 and 3, the right angular process length and the ramus height were reduced 4 weeks after injection, resulting in the mandibular midline deviating to the right side; the right condylar cartilage had reduced thickness and decreased expression of RUNX2, SOX9, and COL II (P<0.05). Two hundred sixty-one genes were differentially expressed (256 downregulated) in the angular process at 3 days post-BTX-A injection, and the calcium signaling pathway was unveiled through the Kyoto Encyclopedia of Genes and Genomes pathway enrichment analysis. Furthermore, TRPC1, Wnt5a, CaMKII, Ctnnb1, and RUNX2 expression were significantly downregulated at 1 and 3 days postinjection. Unilateral injection of BTX-A into the masseter muscle in adolescent rats induces mandibular asymmetry by suppressing the angular process growth on the injected side.

Botulinum toxin A versus platelet rich plasma ultrasound-guided injection in the treatment of plantar fasciitis: A randomised controlled trial

BackgroundPlatelet-rich plasma (PRP) and botulinum toxin type A (BTX-A) injections have proven effective in clinical trials for plantar fasciitis treatment but have not been directly compared. We aimed to compare clinical outcomes in patients undergoing PRP or BTX-A injections. MethodsWe performed a randomised controlled trial (59 patients; 1-year follow-up) to assess efficacy, using pain and functional scales (VAS, AOFAS Hindfoot-scale and FAAM questionnaire) and fascia thickness reduction, in control and single ultrasound-guided BTX-A or PRP injection groups. ResultsThe BTX-A group showed better results at 1-month after treatment. Conversely, the PRP injection was more effective in the long-term, with significant pain reduction and functional improvement. Plantar fascia thickness significantly reduced from months 1 and 3 in the PRP and BTX-A groups, respectively. ConclusionPRP and BTX-A injections are effective in patients with plantar fasciitis with BTX-A achieving better short-term pain reduction and PRP better long-term results. Level of EvidenceLevel I; Randomised Controlled Trial

Velopharyngeal Insufficiency After Botox Injection for Persistent Bruxism.

Botulinum toxin type-A (BTX-A) injections have emerged as a promising treatment for bruxism and temporomandibular joint (TMJ) disorders. However, there is a need for further exploration of optimal dosage, injection techniques, and intervals to maximize treatment effectiveness. Complications, such as velopharyngeal insufficiency, can occur after BTX-A injections, emphasizing the importance of precautionary measures. The utilization of ultrasound guidance and electromyography assistance can aid in precise injections and minimize the risk of complications. In addition, patients should receive appropriate medication and adhere to post-treatment instructions to alleviate symptoms. Follow-up procedures are essential to monitor potential complications, and in some cases, professional mental health care may be required. Further research is warranted to establish the safety and efficacy of BTX-A injections for the treatment of bruxism and TMJ disorders. This case study presents the development velopharyngeal insufficiency in a patient with chronic bruxism 3 days after receiving a BTX-A injection.