Intrathecal Baclofen Infusion-Botulinum Toxin Combined Treatment Efficacy in the Management of Spasticity due to Cerebral Palsy.

BACKGROUND: Cerebral Palsy (CP) is a group of permanent, but not unchanging, disorders of movement and/or posture and motor function, which are due to a non-progressive interference, lesion, or abnormality of the developing/immature brain. One clinical presentation is muscle spasticity, which leads to a significant impact on the individual's functionality and quality of life. Spasticity treatment is multidisciplinary and includes pharmacological and physical intervention; intrathecal baclofen shows a positive effect in severe spasticity and suboptimal response to oral drugs, while local injection of Botulinum toxin type A (BTXA) improves muscle tone, motion and pain. OBJECTIVE: The aim of this study was to evaluate the efficacy of the combined intrathecal baclofen infusion (ITB) - botulinum toxin treatment in the management of spasticity in CP. METHODS: 8 patients with spastic tetraparesis were enrolled. All patients were treated with intrathecal Baclofen; in lower limbs, no spastic symptoms appeared, while marked spasticity was noted in upper limbs. We injected the right and left Biceps Brachial (BB) and Flexor Digitorum Superficialis (FDS) muscles with botulinum toxin type A. All patients underwent Myometric measurement, Ashworth Scale, Numerical Rating Scale, and Visual Analogic Scale evaluation before infiltration (T0), 30 days after injection (T1), 60 days after injection (T2), and 90 days after treatment (T3). RESULTS: All data demonstrated an improvement in spasticity, pain, quality of life, and self-care during the study, with p < 0.05. No side effects appeared. CONCLUSION: This study demonstrated the efficacy and safety of intrathecal baclofen infusion and botulinum toxin combined treatment in the management of spasticity, pain, quality of life, and selfcare in CP patients.

Clinical Onset of Action of Incobotulinum Toxin A Preparation.

BACKGROUND: Many studies in vitro compared the onset of action, maximum efficacy, and duration of botulinum toxin type A (BoNT/A) preparations. OBJECTIVE: In this study, we analyzed the onset of action of BoNT/A preparation free of complexing proteins in patients with upper limb spasticity post stroke up to 30 days after treatment. METHODS: 75 patients affected by Biceps Brachii spasticity were enrolled. Outcome measures were instrumental muscle tone modification (myometric measurement), improvement of Modified Ashworth Scale (MAS), improvement of elbow's passive extension, and improvement of compound muscle action potential (cMAP) evaluated by electroneurography. We analyzed data at t0 (pre-injection), t1 (1 day after), t2 (7 days after), t3 (14 days after), and t4 (30 days after). RESULTS: All measurements decreased at t2, t3, and t4 with initial improvement at t2 and maximum improvement at t4; no statistical difference at t1 was found. CONCLUSION: This study demonstrated the onset of Incobotulinumtoxin A efficacy started after 7 days; this rapid action and efficacy of BoNT/A preparation could improve an intensive rehabilitation program after some days post-injection. Early clinical onset of action could be by the absence of complexing proteins in the preparation.

Electronic Method (Pro-Kin) for Improving And Speeding up The Recovery after Ankle Sprain.

BACKGROUND AND OBJECTIVE: Ankle sprains, very common injuries occurred especially during sports activities, are mainly caused by indirect trauma, which influences exaggerated stress exceeding the strength of stabilization mechanisms. Up to 85% of such injuries result from a sudden flexion and inversion of the foot. In this study, we analyzed the effectiveness of the platform Pro-kin, an innovative system that has given us the possibility to combine the functionality of the older proprioceptive boards with very accurate software in order to improve and accelerate the recovery after ankle injuries. METHODS: 30 patients with moderate ankle sprain outcomes in two groups (A and B) were included in this study. Group A was only treated with proprioceptive exercises for 3 weeks, while the group B was trained with the innovative Pro-kin. In both groups, we evaluated VAS scale, the ratio between the number of circumductions performed by the injured foot and the time spent on doing them and the percentage of load among the injured and the healthy foot in statics and dynamics with electronic baropodometry. Our data has been collected at t0 (beginning of study), t1(one week later), t2 (two weeks later), t3 (one month later), t4 (two months later), and then analyzed by the two-way analysis of variance (2-way ANOVA) test. RESULTS: At t0 no statistical differences of pain in the 2 groups (3.3 and 3.4); the values were similar, as well as at time t1, t2, t3 and t4. Therefore we deduce that Pro-kin treatment is not painful. The number of circumductions performed was definitely better in B group since the first week; for the A group the values considerably increased only at t3 (one month later). Comparing the load percentages on two feet detected by the electronic baropodometer in statics and in dynamics, we deduced that the patients of A group tend to lean mostly on the healthy foot than B group. CONCLUSIONS: This study demonstrates that new technological resources (such as Pro-kin) may be helpful to improve and speed up the recovery of ankle sprain in athletes.

Electrophysiological and Clinical Improvement in Non-Invasive Treatment of Carpal Tunnel Syndrome.

BACKGROUND AND OBJECTIVE: Carpal tunnel syndrome (CTS) is the most common form of nerve entrapment. Clinically, various signs and symptoms compare due to overexposure to mechanical vibrations transmitted to the wrist bones and cartilage, resulting in compression of the sensory and motor nerve fibers of the median nerve. Early symptoms include nocturnal paresthesia and electromyography reveals reduced sensory nerve conduction velocity. Aim of this study was to evaluate the efficacy of a dietary integrator composed of acetyl-L-carnitine, α-lipoic acid, quercetin, bromelain, pantothenic acid, C and B1 and B2 and B6 and B12 vitamins in patients with early (minimal) carpal tunnel syndrome. METHODS: 36 patients (28 female and 8 male) with early CTS characterized by sensory nerve demyelination and inflammation of the transverse carpal ligament. Patients were divided into two groups, group A (18 patients received physical therapy) and group B (18 patients received physical therapy and an oral integrator). Clinical (sleep quality questionnaire to measure severity of paresthesia) and neurophysiological assessment (Sensory Nerve Conduction Velocity) performed at baseline, and then at 30 and 60 days after treatment. RESULTS: Sleep quality and Sensory Nerve Conduction Velocity data analysis show improvement in both groups at 30 and 60 days, with statistical difference between them in both time of analysis. CONCLUSION: In the early CTS, with sensory fibers damage, use of dietary integrator, such as Micronil Dol®, composed of acetyl-L-carnitine, α-lipoic acid, quercetin, bromelain, pantothenic acid, C and B1 and B2 and B6 and B12 vitamins can be effective in quick recovery of median nerve sensory.

Botulinum Toxin Type A and Physiotherapy in Spasticity of the Lower Limbs Due to Amyotrophic Lateral Sclerosis.

Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease (unknown pathogenesis) of the central nervous system that causes death within 1-5 years. Clinically, flabby paralysis, areflexia, muscular atrophy, and muscle fasciculations, signs of II motor neuron damage, appear. Sometimes, clinical manifestations of damage of the I motor neuron come out in lower limbs; spastic paralysis, iperflexia, and clonus emerge, and they impair deambulation and management of activities of daily living, such as personal hygiene or dressing. Thus, the first therapeutic approach in these patients involves antispasmodic drugs orally followed by botulinum toxin type A injection (BTX-A). In this study, we study the efficacy of BTX-A and physiotherapy in lower limb spasticity due to ALS and no response to treatment with oral antispastic drugs. We evaluated 15 patients (10 male and five female), with a mean age of 48.06 ± 5.2 with spasticity of adductor magnus (AM), at baseline (T0, before BTX-A treatment) and in the following three follow-up visits (T1 30 days, T2 60 days, and T3 90 days after infiltration). We evaluated myometric measure of muscle tone, the Modified Ashworth Scale of AM, Barthel Index, Adductor Tone Rating Scale, and Hygiene Score. The study was conducted between November 2018 and April 2019. We treated AM with incobotulinum toxin type A (Xeomin®, Merz). Spasticity (myometric measurement, Adductor Tone Rating Scale, and Modified Ashworth Scale) and clinical (Barthel Index and Hygiene Score) improvements were obtained for 90 days after injection (p < 0.05). Our study shows the possibility of using BTX-A in the treatment of spasticity in patients with ALS and no response to oral antispastic drugs, with no side effects. The limitation of the study is the small number of patients and the limited time of observation; therefore, it is important to increase both the number of patients and the observation time in future studies.

Pain and Muscles Properties Modifications After Botulinum Toxin Type A (BTX-A) and Radial Extracorporeal Shock Wave (rESWT) Combined Treatment.

BACKGROUND AND OBJECTIVE: Spasticity (most common disability in upper motor neuron syndrome or UMNS) caused an inability of patients' to perform daily activities and a decrease inquality of life. One of the promising methods nowadays, but still not widely used in everyday practice, for spasticity reduction is extracorporeal shock wave. The aim of this study was to evaluate the objective clinical effects of combined treatment botulinum toxin type A and radial Extracorporeal Shock Wave Therapy in spasticity post stroke. METHODS: We considered 30 subjects (14 female and 16 male) with post stroke spasticity of Biceps Brachii, Superficial Flexor Digitorum, Gastrocnemius Medialis and Lateralis and we divided patients into two groups (group A received botulinum toxin injection and physiotherapy while group B received botulinum toxin injection, rESWT and physiotherapy). Assessments were performed before treatment (t0), after 1 (t1), 2 (t2) e 3 (t3) months using Modified Ahworth Scale, Visual Analogical Scale for pain and MyotonPro® device (to assessed myometric evaluation of muscles tone and stiffness). RESULTS: Visual Analogical Scale, Modified Ahworth Scale, muscles tone and stiffness statistically decreased until t3 in the group A and in the group B, but the differences between the two groups were significant at the t1 only. CONCLUSION: Radial Extracorporeal Shock Wave Therapy could be an effective physical treatment aimed at the reduction of upper and lower limbs spasticity and could lead to the improvement of trophic conditions of the spastic muscles in post-stroke.

Efficacy and Non Invasive Treatment of Sialorrhea in the Goldenhar Syndrome.

BACKGROUND AND OBJECTIVE: Goldenhar syndrome (ocular-auricular-vertebral syndrome), a rare congenital condition arising from defects in the first and second brachial arches, consists in clinical variety of features ranging from facial abnormalities, ear-eye abnormalities, vertebral defects and congenital heart problems and severe obstructive sleep apnea. Due to craniofacial abnormalities, patients presents mechanical obstructive phenomena and sialorrhea that cause prone position, language's fastening, use of nasopharyngeal cannulas and tracheal intubation. METHODS: In this article, we report a case of a 16 years old child affected by Goldenhar syndrome and sialorrhea to demonstrate improvement of the daily patient management, through inoculations of botulinum toxin type A. Due to severe sialorrhea which caused tracheobronchial daily aspirations, the caregivers used an external aspirators. RESULTS: In the first infiltration (August 2016) the parotid and submandibular glands bilaterally were inoculated with incobotulinum toxin type A (Xeomin®, Merz Pharma) with dosages of 5 UI for each of them, for a total of 20 UI without clinical efficacy (no quantitative and qualitative saliva reducing during 3 months). In the second (November 2016) and third (February 2017) infiltrations each parotid and each submandibular glands were injected with a (dosage of 7 UI and 5 UI respectively (total of 24 UI of incobotulinumtoxin A) with important clinical results (saliva production and tracheo-bronchial aspirations reduced). CONCLUSION: Therefore, botulinum toxin type A could be a good and non invasive treatment of sialorrhea in Goldenhar syndrome to improve oral hygiene and daily patient management.

"Appropriate Treatment" and Therapeutic Window in Spasticity Treatment with IncobotulinumtoxinA: From 100 to 1000 Units.

Many neurological diseases (ischemic and hemorrhagic stroke, multiple sclerosis, infant cerebral palsy, spinal cord injuries, traumatic brain injury, and other cerebrovascular disorders) may cause muscle spasticity. Different therapeutic strategies have been proposed for the treatment of spasticity. One of the major treatments for tone modulation is botulinum toxin type A (BTX-A), performed in addition to other rehabilitation strategies based on individualized multidisciplinary programs aimed at achieving certain goals for each patient. Therapeutic plans must be precisely defined as they must balance the reduction of spastic hypertonia and retention of residual motor function. To perform and optimize the treatment, an accurate clinical and instrumental evaluation of spasticity is needed to determine how this symptom is invalidating and to choose the best doses, muscles and times of injection in each patient. We introduce an “appropriate treatment” and no “standard or high dosage treatment” concept based on our retrospective observational study on 120 patients lasting two years, according to the larger Therapeutic Index and Therapeutic Window of Incobotulinumtoxin A doses from 100 to 1000 units. We studied the efficiency and safety of this drug considering the clinical spasticity significance for specialist physicians and patients.

Use Of External Intrathecal Infusion Pumps In The Management Of Septic Complications: A Case Report.

Spasticity is a motor disorder with an increased muscle tone, typically associated with spasms, weakness and lack of coordination. It is an invalidating and debilitating pathology, characterized by pain, limited autonomy in activities of daily living, development of severe lesions. Spasticity can be adequately treated with physiotherapy, muscle relaxants drugs or topical treatment with botulinic toxin type A. Intrathecal baclofen therapy is very effective in the treatment of severe and generalized spasticity. Sometimes, soft tissues adjacent to the implant intrathecal infusion become infected; removing intrathecal infusion and systemic antibiotic therapy are best solution for clinical cure. However, removing intrathecal baclofen therapy could increase muscle spasticity with enhancement of pain and clonus that can worsen quality of life. In this study, we evaluated clinical improvement after complete healing of the septic focus and implantation of a new infuser.

Objective Assessment of the Rheological Muscle Property in the Treatment of Fibromyalgia.

Fibromyalgia (FM), clinical condition characterized by several signs and symptoms such as widespread pain, trigger point, morning stiffness and extreme tiredness for scarce hours of sleep, is linked to several changes in several brain neurotransmitters, particularly serotonin and norepinephrine. Consequently, the Neural Vegetative System works more and so it generates an exaggerated muscular contraction, sweating and constriction of blood vessels. The aim of our study was to treat a selected group of female patients suffering from FM with duloxetine with physiotherapy. We used two clinical scales (VAS and FIQ) and an objective evaluation such as myometric. The analysis of the data Myoton used during any inspection showed a statistically significant reduction in the values of muscle tone in each district analyzed. This finding was also confirmed by the patients themselves who have experienced a significant welfare and less muscle tension in different locations, as evidenced by data obtained from the clinical scales used by us. In addition, our patients were thought to be satisfied with the improvements not only subjective, but also with the objective witnessed myometry, making them a share of the study and feeling constantly monitored for treatment aimed at a real reduction in muscle stiffness. In conclusion, our study demonstrates combined treatment duloxetine- physiotherapy effectively reduces a symptom often disabling and particularly troublesome in patients with FM as the exaggerated muscle contraction.