Efficacy Of Botulinum Toxin Type Research Articles

Response to Botulinum Toxin Type-A in Patients with Refractory Chronic Migraine

Background: Due to its debilitating nature, refractory chronic migraine (RCM) is primarily associated with a poor quality of life. However, controversy remains regarding the efficacy and safety of botulinum toxin for treating RCM. Objectives: The aim of this study was to investigate the efficacy of botulinum toxin type A (BTX-A) in patients with RCM. Methods: In this retrospective cross-sectional study conducted between April 2016 and March 2021, RCM patients who were resistant to conventional therapies and received BTX-A injections were followed for 7 and 14 days after the injection. The outcome variables included the frequency, duration, and severity of migraine episodes, the need for painkillers, adverse events, and the patient's perceived improvement. Data were analyzed using SPSS. Results: In total, 52 RCM patients with a mean age of 31.84 years participated, of whom 69.2% were female. The frequency of migraine episodes decreased from a baseline of 9.84 to 3.94 and 1.25 at 7 and 14 days after injection, respectively (P < 0.001). The duration of migraine episodes dropped from 3 hours at baseline to 1.74 and 1.17 hours at 7 and 14 days post-BTX-A injection, respectively (P < 0.001). The severity of migraines alleviated from 8.07 at baseline to 6.48 and 3.38 at the respective follow-up times (P < 0.001). The need for painkillers also decreased at follow-ups (P < 0.001). Males achieved better treatment outcomes regarding the frequency of migraine episodes and the need for medications compared to females following BTX-A treatment (P < 0.05). Frontotemporal and frontotemporal-occipital headache distributions showed fewer migraine episodes, shorter duration, less severity, and lower need for painkiller consumption compared to other migraine types (P < 0.05). The most common adverse event was localized pain (42.3%), followed by itching (25.0%). A considerable number of patients felt improvement. Conclusions: According to our findings, BTX-A is a safe and well-tolerated treatment for patients with RCM. Validation of these results requires adequately precise studies investigating the effect of BTX-A in detail.

Effects of botulinum toxin type A in patients with painful temporomandibular joint disorders: a systematic review and meta-analysis.

To assess the therapeutic efficacy of botulinum toxin type A (BTX-A) for managing myofascial pain related to temporomandibular disorders (TMDs). This study was conducted according to the PRISMA 2020 statement guidelines. The PubMed, Embase, and Cochrane Library databases were searched. Only randomized controlled trials were included. The primary outcome was a pain score on the visual analog scale, and the secondary outcomes were maximum mouth opening and adverse effects. The Cochrane risk of bias tool was used to assess risk bias. A meta-analysis of studies with the same interventions, controls, assessment methods, and follow-up durations was performed. A total of 519 studies were retrieved, of which 20 randomized controlled trials were included in the qualitative analysis and six were included in the meta-analysis. The results showed that, compared with placebo, BTX-A injection was more effective at relieving myofascial pain, and its effect was similar to that of conventional methods. However, there was no difference in maximum mouth opening between the two groups. After the study assessment with the RoB 2.0 tool, six studies showed a low risk of bias, 13 studies showed some concerns regarding the reported results, and only one study showed a high risk of bias. Adverse effects of BTX-A injection were observed in four studies. In conclusion, BTX-A is effective at relieving pain in TMD patients but does not improve mouth opening. To minimize adverse effects, we recommend a low dose of BTX-A for TMD patients who do not experience complete pain relief from conservative treatments.

Efficacy of augmented-dosed surgery versus botulinum toxin A injection for acute acquired concomitant esotropia: a 2-year follow-up

Background/aimsThis study aims to evaluate the clinical efficacy of botulinum toxin type A (BTXA) injection and augmented-dosed surgery in the treatment of acute acquired concomitant esotropia (AACE), and explore potential...

Uso da Toxina Botulínica Tipo A em pacientes com Neuralgia Trigeminal

This article provides a systematic review of the efficacy of Botulinum Toxin Type A (TBA) in treating trigeminal neuralgia (TN), a painful disorder affecting the trigeminal nerve. TN is described in the literature as a facial pain of acute nature, often unilateral, characterized by episodes of intense and transient pain, comparable to electric shocks. The diagnosis is made through a detailed evaluation that includes anamnesis, characterization of symptoms, and imaging tests to exclude similar pathologies. Conventional therapy for TN involves the use of carbamazepine; however, in cases of pharmacological resistance or ineffectiveness of standard treatments, TBA emerges as a viable therapeutic alternative. The efficacy of TBA, as demonstrated in retrospective and prospective studies, is due to its ability to inhibit the release of neurotransmitters responsible for pain transmission and inflammatory processes. Various studies corroborate the efficacy of TBA, especially in patients over 50 years old, observing substantial improvement in symptoms with minimal adverse effects. The administration of TBA is carried out directly in the trigger zones, where it has proven to be well-tolerated, providing significant improvement in the quality of life of the affected patients. Despite promising results, the literature suggests the need for additional studies to optimize the dosage protocols and application of TBA, aiming to ensure its efficacy and safety in the long term. In conclusion, this article reiterates that TBA represents an effective and minimally invasive therapeutic alternative for the treatment of TN. However, it is essential to develop individualized therapeutic protocols and conduct more comprehensive studies to consolidate its use as the treatment of choice.

The efficacy of botulinum toxin in neuropathic pain: a systematic review

Introduction Neuropathic pain (NP) is characterised as a lesion or disease directly affecting the somatosensory system. This study aims to analyse the efficacy of botulinum toxin type A (BT-A) in the treatment of neuropathic pain. Methods This systematic literature review, guided by PRISMA, applied the PICO strategy with the following criteria: (P = patients with neuropathic pain, I = botulinum toxin, C = placebo or active drug, and O = pain relief). Results Fourteen articles, all randomised controlled trials with a placebo control, were included in the review. A total of 645 patients were randomised, with 353 patients receiving treatment with botulinum toxin type A in doses ranging from 25U to 400U. The evaluated studies addressed trigeminal neuralgia, diabetic polyneuropathy, post-herpetic neuralgia, spinal cord injury, phantom limb pain, and peripheral neuropathic pain after trauma or surgery. Conclusion BT-A has emerged as a promising treatment for various origins of neuropathic pain. Therefore, future studies should adopt stricter criteria regarding dosage and routes of administration to ensure effective and consistent BT-A application.

Effects of botulinum toxin type A in the prevention and treatment of facial hypertrophic scars: A meta-analysis.

A meta-analysis was conducted to comprehensively evaluate the prophylactic and therapeutic efficacy of botulinum toxin type A (BTX-A) in the treatment of facial hypertrophic scars. Computerised searches were performed in databases, from their inception to November 2023, including Embase, Google Scholar, Cochrane Library, Wanfang, PubMed and China National Knowledge Infrastructure databases, focusing on randomised controlled trials (RCTs) that investigated the use of BTX-A for treating facial hypertrophic scars. Two researchers independently screened the literature, extracted data and conducted quality assessments. Stata 17.0 software was employed for data analysis. Seventeen RCTs were ultimately included, involving 1605 patients who underwent facial cosmetic surgery. The analysis revealed that compared with conventional treatments, BTX-A significantly reduced visual analogue scale (VAS) scores (standardized mean difference [SMD]: -3.50, 95% confidence interval [CI]: -5.16 to -1.84, p < 0.001) and Vancouver scar scale (VSS) scores (SMD: -2.86, 95% CI: -4.03 to -1.68, p < 0.001), and narrowed scar width (SMD: -1.80, 95% CI: -2.48 to -1.13, p < 0.001), while also enhancing the overall effectiveness of the treatment. This study indicates that BTX-A is an effective modality in the prophylaxis and treatment of facial hypertrophic scars, significantly alleviating scar-related pain and preventing scar widening, and is thus worthy of broader clinical application.

Gait analysis using three-dimensional motion and ground reaction force systems in patients with hemiplegia treated with botulinum toxin type A in ankle plantar flexors.

Objective: The efficacy of botulinum toxin type A (BoNT-A) injection on spasticity has usually been measured using the range of motion (ROM) of joints and Modified Ashworth Scale (MAS); however, they only evaluate muscle tone at rest. We objectively analyzed the gait of three patients with hemiplegia using three-dimensional motion analysis and ground reaction force (GRF) systems to evaluate muscle tone during gait. Materials and Methods: We measured passive ankle dorsiflexion ROM with knee extension and the MAS score for clinical evaluation, and gait speed, stride length, single-leg support phase during the gait cycle, joint angle, joint moment, and GRFs for kinematic evaluation before and one month after BoNT-A injection. Results: All patients showed an increase in ankle dorsiflexion ROM, improvement in MAS score, and increase in stride length. Case 1 showed an increase in gait speed, prolongation of the single-leg support phase, increase in hip extension angle and moment, and improvement in the vertical and anterior-posterior components of the GRFs. Case 2 showed an increase in gait speed, improvement in double knee action, increase in ankle plantar flexion moment, and improvement in propulsion in the progressive component of the GRFs. Case 3 exhibited a laterally directed force in the GRFs. Conclusion: We evaluated the effects of BoNT-A injections in three patients with hemiplegia using three-dimensional motion analysis and GRFs. The results of the gait analysis clarified the improvements and problems in hemiplegic gait and enabled objective explanations for patients.

Comparison of Efficacy of Botulinum Toxin Injection and Conventional Oral Drugs for Treatment of Refractory Migraine

Background: Background: Migraine, a debilitating neurological condition, significantly impacts quality of life. Despite various treatments, some cases remain refractory to conventional therapies. This study explores the efficacy of Botulinum Toxin Type A (BOTOX) injections compared to Conventional Oral Drugs (CODs) in treating refractory migraines, offering potential advancements in migraine management. Objectives: This single-center retrospective cohort study compared the efficacy and safety of Botulinum toxin (BOTOX) injection and Conventional Oral Drugs (COD) for treating the refractory migraine. Methods: Between May and August of 2023, 78 adults with refractory migraine were enrolled at tertiary care center in Islamabad. Their demographic data revealed the mean age of 46.5 years (SD=10.09), gender distribution of 28 males (35.90%) and 50 females (64.10%), and distribution of 27 employed (34.61%) and 51 unemployed (65.30%). Results: Average duration of refractory migraines was 9.72 years and average number of migraines per month was 22. The number of headache days per month decreased from 22 at baseline to 19 after two months and to 12 after three months (p=0.239) as the primary outcome measure (p&gt;0.05). The VAS scores decreased substantially from 7.6 to 5.5 (p=0.049), indicating decrease in headache severity (p&lt;0.05). Scores on Migraine-Specific Quality of Life (MSQ) increased from 43 to 73% (p&gt;0.05). The Migraine Disability Assessment (MIDAS) scores decreased from 66 to 48 (p=0.047) and Headache Impact Test (HIT-6) scores decreased from 69 to 40 (p=0.025), indicating an improvement in disability and quality of life (p&lt;0.05). Injection site pain (n=35), nausea (n=25), dizziness (n=15), fatigue (n=12), parched mouth (n=5), and muscle weakness (n=5) were reported as adverse effects. Conclusion: While BOTOX treatment significantly improved measures of headache severity, disability, and quality of life, patient tolerability and potential distress must be considered when selecting this treatment.

Efficacy of botulinum toxin type A in bruxism: a scoping review

This study aims to carry out a scoping review on the scientific production of the effectiveness of TxBA for bruxism. Eligibility criteria were defined as studies on the effectiveness of TxBA for bruxism, published in scientific publications until July 2023.This research revealed a variety of methodological approaches and data interpretation on the effectiveness of bruxism management using TxBA. Studies, including randomised clinical trials and case reports, have shown consistent results, highlighting the effectiveness of TxBA in reducing symptoms and signs of bruxism, although with variations in doses and assessment methods. Systematic reviews and overviews also confirmed the benefits, pointing to a reduction in the frequency of bruxism and muscle relaxation. However, the general assessment indicated divergences in the evidence, highlighting the need for research with better methodological rigour to establish definitive conclusions about the use of TxBA in the management of bruxism. Therefore, while the evidence points to the potential effectiveness of TxBA, uncertainty persists due to methodological variation and the lack of studies with methodological characteristics that converge with each other.

Abstract 11520: Safety and Efficacy of Botulinum Toxin Type A for Prevention of Postoperative Atrial Fibrillation in Cardiac Surgery Patients: Pulmonary Function Test Results From the Phase 2 NOVA Study

Background: Postoperative atrial fibrillation (POAF) is the most common complication after cardiac surgery. Autonomic neuromodulation, including injection of botulinum toxin into epicardial fat pads, may suppress and/or attenuate atrial fibrillation. The respiratory safety of a potential preventative treatment for AF is critical. Aim: To assess efficacy and pulmonary safety of botulinum toxin type A (BoNT/A; AGN-151607) 125U and 250U vs placebo for prevention of POAF after coronary artery bypass graft and/or valve surgery. Methods: NeurOtoxin for the PreVention of post-operative Atrial fibrillation (NOVA; NCT03779841) was a phase 2, international, multicenter, randomized, placebo-controlled trial. The primary endpoint was proportion of patients with continuous AF ≥30 seconds within the first 30 days. Respiratory function was assessed via pulmonary function tests (PFTs) performed at baseline and day 30 after treatment. Adverse events (AEs), serious adverse events (SAEs), and time to extubation were recorded. Results: A total of 323 patients were randomized: BoNT/A 125U (n=106), 250U (n=109), placebo (n=108). The primary endpoint occurred in 46.1% of the placebo group, 36.5% of the 125U group (relative risk [RR] vs placebo, 0.80 [95% CI: 0.58, 1.10]; P =0.16), and 47.2% of the 250U group (RR vs placebo, 1.04 [95% CI: 0.79, 1.37]; P =0.78). Baseline, day 30, and change from baseline PFT results were similar for active treatment vs placebo ( Table ). Median time to extubation was 9.7, 9.6, and 9.6 h in the placebo, 125U, and 250U groups, respectively. Respiratory AEs were reported in 42.9%, 38.1%, and 50.5% of patients, and respiratory SAEs in 11.4%, 6.7%, and 5.5% of patients in the placebo, 125U, and 250U groups, respectively. Conclusion: In this analysis of respiratory function, there appeared to be no detrimental effect of AGN-151607 compared with placebo, as evidenced by similar outcomes in PFT parameters and respiratory AE/SAE incidences among treatment arms.

Effect of Botulinum Toxin on Masticatory Muscle Pain in Patients with Temporomandibular Disorders: A Randomized, Double-Blind, Placebo-Controlled Pilot Study.

This study aimed to evaluate the efficacy of botulinum toxin type A (BoNT/A) in patients with temporomandibular disorders (TMDs) associated with masticatory muscle pain (MMP) and headaches. This randomized, double-blind, placebo-controlled pilot study is the first clinical trial to evaluate both disorders simultaneously. Twenty-one patients with myogenous TMD were randomly assigned to two groups. The experimental and control groups received injections of either BoNT/A or saline into the sites showing tenderness after palpation of a total of 16 muscle areas, including each masseter, a temporalis, splenius capitis, sternocleidomastoid, and trapezius muscle. During each visit, the clinical effects, based on the intensity of orofacial pain (OVAS), headache (HVAS), number of tender points (TPs), maximum mouth opening (MMO), and headache frequency (HF), were evaluated at four time points, namely, pre-injection and 4, 8, and 12 weeks after the injection, in both groups. Friedman and Mann-Whitney tests were used for the analyses. In the experimental group, the reductions in OVAS, TP, HVAS, and HF showed significant differences over time, excluding MMO, whereas there was no significant difference in any of the variables in the control group. In addition, the decline in TPs was significantly different between the experimental and control groups at all time points, especially after 4 and 12 weeks, compared to that during pre-injection. In conclusion, treatment with BoNT/A was relatively effective for masticatory muscle pain caused by TMDs and headache compared to the saline placebo.

The efficacy of botulinum toxin type A treatment and surgery for acute acquired comitant esotropia.

To compare the long-term efficiency of botulinum toxin type A (BTXA) injection and surgery on acute acquired comitant esotropia (AACE). This retrospective study enrolled patients with AACE from January 2020 to August 2022. The horizontal angle of deviation pre- and post-treatment was measured. Deviations in BTXA and surgical treatment were compared. The BTXA group was divided into adequate treatment (AT) and inadequate treatment (inAT) subgroup based on the deviation of no more than 4 prism diopters (at near and distance) or temporary exotropia at the 2 week follow-up. The two subgroups were compared to determine the long-term efficacy of BTXA treatment. Ninety-two patients with AACE were included. Follow-up was 6 months. The deviations of the surgery and BTXA group were significantly smaller at the 6 month follow-up than at pre-treatment (p < 0.001). The deviation before treatment in the surgery group was larger than in the BTXA groups (p < 0.001) but smaller at the 6 month follow-up (p < 0.001). The deviation was similar in the AT-BTXA and inAT-BTXA subgroups before treatment (p = 0.322 for distance and p = 0.051 for near) but smaller in the AT-BTXA subgroup at 6 month follow-up (p < 0.001 for near and distance). Surgery and BTXA successfully treat AACE. Surgery has a more precise and lasting therapeutic effect than BTXA. AACE patients adequately treated with BTXA and with deviations of no more than 4 prism diopters at 2 weeks follow-up had better outcomes.

Clinical efficacy of botulinum toxin type A in the treatment of fasciitis pain: A systematic review and meta-analysis.

The purpose of this meta-analysis was to assess the effectiveness of botulinum toxin type A (BoNT-A) in reducing pain associated with fasciitis. By synthesizing the findings from multiple studies, we aimed to provide a comprehensive evaluation of the current evidence regarding the efficacy of BoNT-A in the treatment of fasciitis pain. To identify studies for our report, we conducted electronic database searches of Embase, PubMed, Web of Science, and the Cochrane Library from their inception to November 20, 2022. We included only randomized controlled trials that examined the therapeutic effects of BoNT-A on fasciitis pain, with the primary outcome measure being the visual analog scale. We conducted statistical analyses using RevMan 5.4 software. Our final meta-analysis comprised 14 randomized controlled trials involving 537 participants, with 271 patients in the BoNT-A group and 266 patients in the control group. The overall effectiveness of BoNT-A in reducing fasciitis pain was significant, with a mean difference (MD) in visual analog scale score of -2.59 (95% confidence interval [CI], -3.36, -1.82); P < .00001; I2 = 88%. Subgroup analysis revealed that BoNT-A was particularly effective in treating plantar fasciitis (MD = -3.34 [95% CI, -4.08, -2.78]; P < .00001; I2 = 75%), lumbar back fasciitis (MD = -2.17 [95% CI, -3.82, -0.52]; P = .001; I2 = 93%), and neck and shoulder fasciitis (MD = -1.49 [95% CI, -2.76, -0.22]; P = .02; I2 = 61%). BoNT-A has a significant analgesic effect on fasciitis pain. Therefore, BoNT-A presents a promising alternative treatment option for fasciitis (PROSPERO 2022: CRD42022382805).

Does injection pattern matter in upper face BoNT-A application? A prospective split-face andomized trial comparing linear and spot technique.

Although the efficacy of botulinum toxin type A (BoNT-A) has been shown to vary depending on injection layer, reconstitution volumes, and BoNT-A formulations, the impact of injection patterns has been rarely mentioned. This article compared the therapeutic effects in patients treated with BoNT-A with retrograde linear and traditional spot injection techniques. Twenty-eight participants were enrolled in a split-face, patient-blinded randomized clinical trial. Each patient received BoNT-A injected with linear injection technique on one side and with spot injection technique on the other side. Outcomes included the wrinkle improvement rates (WIR) of the two injection techniques determined by the wrinkle scores derived from Antera 3D camera, the muscle activity assessed via ultrasound, and patient-reported pain rating on a numeric pain rating scale (NRS). All participants completed the study. For forehead wrinkles, WIR on the linear side was significantly larger than that on the spot side at 1 week and 1 month (p<0.02). For glabellar wrinkles, WIR on the linear injection side was significantly larger than that on the spot side at 1 week (p=0.04). However, for periorbital wrinkles, WIR on the spot side was significantly larger than that on the linear side at 1 week (p<0.03). No significant difference was observed between the injection patterns in terms of muscle contraction and NRS scores. Compared with the traditional spot injection, the retrograde linear injection shows to be superior in reducing forehead lines and glabellar lines, but less effective in reducing periorbital lines when identical dosages were injected. chictr.org.cn: ChiCTR2100046880.

Neuromuscular retraining therapy combined with preceding botulinum toxin A injection for chronic facial paralysis

Background Neuromuscular retraining therapy (NMRT) is the central treatment for synkinesis. The efficacy of botulinum toxin type A (BTX-A) may be enhanced with the addition of physical therapy. Objectives To investigate the effects of NMRT combined with preceding BTX-A injection (NMRT-B) on facial synkinesis and asymmetry in chronic facial paralysis. Materials and Methods We recruited 99 patients with unilateral facial paralysis and no recovery for > 6 months who underwent NMRT-B for > 1 year. The patients were scheduled to receive NMRT after 1–2 weeks of BTX-A injection. We used a computer-based numerical scoring system to evaluate the facial functions. Primary, secondary, and final facial movement scores were evaluated before and after 1 year of treatment. Results Patients with chronic facial paralysis who underwent NMRT-B exhibited improved facial movement after 1 year of treatment. NMRT-B provided satisfactory control of synkinesis and improved the primary movements. The mean primary and final facial movement scores were significantly increased after treatment, while the mean secondary facial movement scores were significantly decreased. Conclusions and significance NMRT-B improved the final facial movement in patients with chronic facial paralysis and synkinesis, regardless of the degrees of facial synkinesis and asymmetry before treatment.

Safety and Efficacy of Botulinum Toxin Type A in Children With Spastic Cerebral Palsy Aged

In this study, we reviewed the safety and efficacy of botulinum toxin type A (BoNT-A) injection with respect to motor development in children with spastic cerebral palsy aged <2 years. Randomized controlled trials of BoNT-A published between July 1993 and May 2021 were searched in PubMed, WANFANG, CNKI (Chinese National Knowledge Infrastructure), and Cochrane Library Central Register of Controlled Trials using keywords "Botulinum Toxin," "cerebral palsy," "nao xing tan huan," "nao tan," and "rou du du su." The 11-item PEDro Scale was used to rate the quality of all the identified studies. Twelve studies, involving 656 subjects, met the inclusion criteria, and of these, 2 involved patients aged <2 years. Treatment safety was assessed based on adverse event (AE) number and frequency, and efficacy was assessed based on spasticity, range of movement, and motor development. We observed that 3 self-limiting adverse events that were frequently reported included weakness, dysesthesia of the skin, and pain at the injection site. Moreover, there was a significant decrease in the incidence of spasticity and a notable improvement in the range of movement of BoNT-A-treated patients. Therefore, BoNT-A injection shows great safety and efficacy in the treatment of children with cerebral palsy aged <2 years.

Clinical efficacy of botulinum toxin type A in patients with traumatic brain injury, spinal cord injury, or multiple sclerosis: An observational longitudinal study.

NCT04673240.

Current Research of Botulinum Toxin Type A in Prevention and Treatment on Pathological Scars.

Dermatologists have been looking for ways to improve wound healing and postoperative scar appearance. The safety and efficacy of botulinum toxin type A (BTXA) in the prevention and treatment on pathological scars have become the current research hotspot since it was approved by the US FDA in medical cosmetology in 2002. This article aims to provide an overview of the clinical research, limitations, and application prospects of BTXA in the prevention and treatment of traumatic or postoperative pathological scars, which can provide a reference and better understanding of relevant studies. The current research progress was summarized and discussed, with new problems and research ideas being proposed ranging from the molecular mechanism of BTXA in preventing and treating pathological scars to its clinical application via investigation and reference research. BTXA is effective in relieving itching and pain associated with pathological scars, limiting scar hyperplasia along with preventing scar contracture, but the specific mechanism is still not clear. Most of the clinicians have confirmed the clinical effectiveness of BTXA in the prevention and treatment of pathological scars, yet its mode of action and combination therapy need more research.

Efficacy on gait and posture control after botulinum toxin A injection for lower-limb spasticity treatment after stroke: A randomized controlled trial.

To observe the efficacy of botulinum toxin type A (BoNT-A) for the spasticity of the lower-limb post-stroke on gait and posture control. A total of 46 patients with hemiplegia gait were randomly divided into the experimental group (23 patients) and the control group (23 patients). In patients in the experimental group received injections of BoNT-A by electrical stimulation-guided. At the same time, patients of the two groups received routine physical therapy. Gait analysis, plantar pressure analysis, lower-limb Fugl-Meyer assessment (L-FMA), 10 meter walking test (10MWT), timed "Up and Go" test (TUGT), and modified Ashworth Scale assess (MAS) of the lower limbs were performed at 0, 1, 4, and 12 weeks after treatment. At 1, 4, and 12 weeks after treatment, the L-FMA, stride length, speed, and TUGT significantly improved than 0 week in both groups. The L-FMA and peak of forefoot pressure, and MAS results in the experimental group were better than those in the control group at 4 and 12 weeks. The TUGT, speed, and stride length in experimental group was significantly shortened than that in control group at 1, 4, and 12 weeks. Botulinum toxin type A injection can improve motor functions of the lower limb, gait, spasticity, forefoot pressure, and posture control of patients after stroke.

Efficacy of botulinum toxin type A injection for Raynaud's phenomenon and digital ulcers in patients with systemic sclerosis.

Systemic sclerosis (SSc) is an autoimmune, connective tissue disorder of unknown etiology which causes vasculopathy and fibrosis. Raynaud's phenomenon (RP) is a common complication of SSc, which leads to ischemia and gangrenes. Treatment of RP is a clinical problem and often remains insufficient.This study aimed to evaluate the therapeutic efficacy of local injections of botulinum toxin type A (BTX-A) in improving the symptoms of Raynaud's phenomenon (RP) secondary to scleroderma. This parallel single-blinded, placebo-controlled clinical trial enrolled 29 patients with scleroderma. Participants received BTX-A in the first, 2nd, 3rd, and 4th dorsal web spaces and the base of the thumb and small finger of the non-dominant hand and 2.5 ml of sterile normal saline in the opposite hand. Pre-injection measurements and post-injection follow-up evaluations at months 1 and 4 were performed. We compared the outcomes using the paired Student's t-test. The change in pain severity between pre-injection and month 1 follow-up was significantly larger in the BTX-A group (p-value = 0.04). Between pre-injection and month 1 and month 4, the changes in the Raynaud's condition score (RCS) (p-value = 0.02, 0.004, respectively) and the number of Raynaud's attacks (p-value = 0.006, 0.001, respectively) were significantly greater in the BTX-A group. No significant difference was found in terms of paresthesia, skin thickening, upper extremity function, ulcer diameter, number of ulcers, or Raynaud's attack duration between the two groups (p-value > 0.05). In time, the decrease in pain severity, paresthesia, RCS, number of ulcers, and ulcer diameter, and the increase in upper extremity function were significantly greater in the BTX-A group as compared to the placebo group (p < 0.05). Our study showed that local injection of BTX-A is safe and has beneficial therapeutic effects on RP and RP-related digital ulcers in SSc patients.