Cost-effectiveness of botulinum toxin type a in the treatment of post-stroke spasticity.

OBJECTIVE: Treatment strategies for post-stroke spasticity include oral anti-spastic drugs, surgery, physiotherapy and botulinum toxin type A injection. The objective of this study was to compare the cost-effectiveness and outcomes of oral therapy vs. botulinum toxin type A treatment strategies in patients with flexed wrist/clenched fist spasticity. METHODS: Treatment outcome and resource use data were collected from an expert panel experienced in the treatment of post-stroke spasticity. A decision tree model was developed to analyse the data. RESULTS: Thirty-five percent of patients receiving oral therapy showed an improvement in pre-treatment functional targets which would warrant continuation of therapy, compared with 73% and 68% of patients treated with botulinum toxin type A first- and second-line therapy, respectively. Botulinum toxin type A treatment was also more cost-effective than oral therapy with the "cost-per-successfully-treated month" being 942 pounds, 1387 pounds and 1697 pounds for botulinum toxin type A first-line, botulinum toxin type A second-line and oral therapy, respectively. CONCLUSION: In conclusion, botulinum toxin type A is a cost-effective treatment for post-stroke spasticity.     

Treatment of focal upper limb spasticity with botulinum toxin after stroke. Interest of an individual approach.]

INTRODUCTION: It is now demonstrated that botulinum toxin can improve upper limb spasticity after stroke. OBJECTIVES: This study was designed to assess the efficacy of botulinum toxin on upper limb spasticity with an individual approach. METHODS: Prospective study on 18 patients who had disabling spasticity of upper limb after stroke. For each patient, the treatment's target was fixed preliminary to botulinum toxin injection. Evaluation of efficacy (Ashworth scale and predefined targets) was performed at 1 month and treatment continuation was decided individually. RESULTS: A beneficial effect was reported by most patients when the treatment was aimed at improving comfort or quality of life. In one case, the treatment was designed to improve grasping. In that case, no effect was reported. For three patients, a neurotomy was performed in order to obtain a long lasting effect. For nine patients, repeated injections were decided. For the six other patients, no long-standing treatment was performed. DISCUSSION: This study confirms that botulinum toxin can improve comfort of patients with upper limb spasticity. On the base of our experience, we discussed contribution of botulinum toxin to enhance and optimise strategies for the treatment of focal upper limb spasticity with emphasis on the comparison with selective neurotomy.     

Early physiotherapy after injection of botulinum toxin increases the beneficial effects on spasticity in patients with multiple sclerosis

OBJECTIVE: To determine whether additional physiotherapy increases botulinum toxin type A effects in reducing spasticity in patients with multiple sclerosis. DESIGN: A single-blind, randomized, controlled pilot trial with a 12-week study period. SUBJECTS: Thirty-eight patients with progressive multiple sclerosis affected by focal spasticity and who were observed at the Multiple Sclerosis Centre operating in the S. Andrea Hospital in Rome. INTERVENTIONS: For intervention all patients received botulinum toxin type A; the treatment group also received additional physiotherapy to optimize management through passive or active exercise and stretching regimens. MAIN MEASURES: To measure objective and subjective level of spasticity, patients were assessed at baseline, 2, 4 and 12 weeks post treatment by Modified Ashworth Scale and visual analogue scale. RESULTS: When compared with the control group, we found a significant decrease of spasticity by Modified Ashworth Scale (P < 0.01 by t-test) in the treatment group at week 2 (2.73 versus 3.22), week 4 (2.64 versus 3.33) and week 12 (2.68 versus 3.33). The mean (%) difference in Modified Ashworth Scale score between baseline and the end of follow-up was -0.95 (26.1) in the treatment group and -0.28 (7.7) in the control group (P < 0.01). The combined treatment proved also to be more effective by visual analogue scale (P < 0.01) at week 4 (6.95 versus 5.50) and at week 12 (7.86 versus 6.56) but not at week 2 (5.18 versus 5.50; P = 0.41). CONCLUSIONS: Our data suggest that physiotherapy in combination with botulinum toxin type A injection can improve overall response to botulinum toxin.     

Botulinum toxin A in the treatment of spasticity - An open label study

Purpose: To assess the efficacy of botulinum toxin type A in spasticity in upper-motor neuron syndromes. Methods: Twenty-three patients with spasticity resulted from stroke-related hemiplegia, transverse myelitis and multiple sclerosis took part in the study. Following the history and physical examinations of the patients, injections of botulinum toxin-A were applied. The dose ranged from 80 to 400 mouse unit (MU) depending on the size of the muscle injected. In all patients, spasticity, spasms and pain were measured using the Ashworth Scale, Spasm Frequency Score, and Visual Analogue Scale prior to the therapy, at the 1st week, 1st month and 3rd month of the therapy. Results: In all patients, botulinum toxin type A led to a significant decrease in spasticity, spasms and pain after the 1st week, 1st and 3 rd months of the treatment when compared to the baseline values (p<0.001). No significant side effects or complications were observed. Conclusion: Our results have demonstrated that botulinum toxin type A is effective in the management of patients with spasticity due to stroke-related hemiplegia, transverse myelitis and multiple sclerosis, without major adverse effects.     

Effectiveness of botulinum toxin injection with and without needle electromyographic guidance for the treatment of spasticity in hemiplegic patients: a randomized controlled trial

Abstract

Purpose: To compare the effects of botulinum toxin injection with and without needle electromyographic guidance for the treatment of spasticity. Method: A randomized controlled study was conducted in a tertiary university hospital. Twenty-seven adult hemiplegic patients with spasticity due to brain or spinal cord damage were included. Spastic muscles were injected with botulinum toxin with or without EMG guidance. The modified Ashworth scale and modified Barthel index in each patient pre- and post-injection were documented. Results: In group A, which consisted of 15 patients (55.55%), the injection was administered with needle electromyographic guidance, while in 12 patients (44.44%) of group B without electromyographic guidance with the use of anatomic landmarks only. The follow-up period was 3 months. At 3 weeks post-injection, spasticity was decreased (p?<?0.05) in all patients and the mean (SD) reduction of spasticity was higher (p?<?0.05) in group A (1.67 (0.5)) than group B (1.25 (0.46)). Similarly, the mean (SD) functional modified Barthel index improved statistically significantly (p?<?0.001) post-injection (45.37 (8.43)) than pre-injection (54.07 (9.610), especially in group A (p?<?0.05). Conclusion: The effectiveness of intramuscular botulinum toxin injection for the treatment of spasticity in hemiplegic patients is superior when performed with needle electromyographic guidance than without electromyography.

• Implications for Rehabilitation

• It is recommended that botulinum toxin muscle injections of hemiplegic limbs be performed with EMG guidance

• More spasticity reduction and functional improvement at 3 months post-injection was observed in patients injected with botulinum toxin by the use of combined EMG guidance and anatomic landmarks

• EMG guidance might also save amount of botulinum toxin due to less spasticity observed during injection than when injection is performed with anatomic landmarks only

     

Prise en charge de la spasticité dans la sclérose en plaques

Spasticity is a frequent symptom in cases of multiple sclerosis. The treatment depends on whether the spasticity is focal or diffuse. The recent recommendations issued by AFSSAPS give details concerning first-line therapy: botulinum toxin A for cases of focal spasticity and intrathecal baclofen for diffuse spasticity. A prior evaluation can be made with the help of reversible tests to set out the functional objectives of the therapy.     

Utilisation de fortes doses de toxine botulique de type A chez l'enfant: intérêt et sécurité en pratique clinique

The purpose of this article is to examine the current state of administering high doses botulinum toxin type A for the treatment of chidhood spasticity, particularly Cerebral Palsy. The inter-relationship between the Cerebral Palsy neurological maturation and the early management is discussed, including identification of common gait patterns and the choice of target muscles for focal or multi focal spasticity management. High doses of botulinum toxin type A, when multilevel and integrated management approach is indicated, appear to be a safe, efficacious treatment for multi focal Cerebral Palsy spasticity. A review of literature guides the clinician about necessary adaptation of botulinum toxin doses and found no evidence that higher doses result in a increase of complications. Further studies would be interesting in order to evaluate long term safety and efficacy of this therapy in Cerebral Palsy.     

Spinal cord injury and use of botulinum toxin in reducing spasticity

Spasticity is commonly seen after spinal cord injury, and a large percentage of patients with spinal cord injury will need treatment to control it. Although oral medications do a fair job of controlling spasticity in most patients, some patients will need additional forms of treatment. In many cases, oral medications alone do not adequately control spasticity or the patient cannot tolerate the side effects. In these instances, botulinum toxin may help control the spasticity for approximately 3 months after injection. The amount of botulinum toxin and the injection sites can be tailored to meet individual patient needs. Botulinum toxins can reduce spasticity, improve function, and reduce the amount of needed assistance.     

The use of botulinum toxin for spasticity after spinal cord injury

OBJECTIVE: To describe the use and effects of botulinum toxin (BTX) injections in persons with spinal cord injury (SCI) and focal spasticity. DESIGN: Chart review of patients with SCI receiving their first injection of BTX for spasticity control at a freestanding urban rehabilitation hospital. Charts were reviewed for history and level of SCI, one of five self-identified goals (ambulation, positioning, upper-extremity function, hygiene, and pain control) before and after injection; site and doses of BTX used; and self-reported outcome on clinical follow-up. RESULTS: Charts of 28 adults receiving BTX were reviewed. All patients received BTX type A. Dosages of BTX ranged from 10 to 119 units per muscle. Improvement was noted for 56% in ambulation and 71% in positioning. Overall, upper-extremity function improved in 78%, hygiene improved in 66.6%, and pain decreased in 83.3%. Early use of BTX injections (less than a year after onset of symptoms) vs. late use of BTX injections did not influence effectiveness. CONCLUSIONS: BTX seems to be an effective treatment for focal spasticity and for reducing disability in persons with SCI. Randomized trials are needed to confirm the value of this treatment in the setting of SCI.     

Botulinum toxin and spinal cord injury]

OBJECTIVE: To realize a clarification about the interest of the use of botulinum toxin in spinal cord injured patients. METHOD: Interrogation of Medline database (crossing of botulinum toxin and spinal cord injury). We have also analyzed data from R. Poincaré Hospital in 2001. RESULTS: Three articles of the twenty-five selected, treated effectively of botulinum toxin effect in the limbs muscles of spinal cord injured patients. DISCUSSION: There are some indications of botulinum toxin in spinal cord injured patients ASIA C and D when spasticity induce focal functional discomfort. Indications are exceptional for ASIA A and B patients. No study showed improvement of functional abilities after botulinum toxin injection in spinal cord injured patients. Published studies only covered small number of patients.     

Combining botulinum toxin and phenol to manage spasticity in children

OBJECTIVE: To describe the specific techniques and adverse reactions of using concurrent, multiple injections of both botulinum toxin and phenol to manage spasticity in children with cerebral palsy (CP) and other neurologic conditions. DESIGN: A retrospective case series. SETTING: A tertiary care children's hospital. PARTICIPANTS: Consecutive patients (N=68) with spasticity related to CP or other neurologic conditions. INTERVENTION: Ninety injection sessions combining botulinum toxin and phenol to manage spasticity. MAIN OUTCOME MEASURE: Documentation of adverse reactions. RESULTS: The mean phenol dosage was 9.5mL at a mean of 0.6mL/kg per injection dose. The mean botulinum toxin type A (Botox) dose injected was 193U (12U/kg), and the mean of botulinum toxin type B (Myobloc) dose injected was 7750U (530U/kg). The mean number of muscles injected was 14. Adverse reactions are described but were infrequent. Dysesthetic hand pain occurred in 2 patients. One patient developed a systemic reaction to Myobloc. CONCLUSIONS: Using botulinum toxin and phenol injections allowed many muscles to be injected to manage spasticity in children with CP and other neurologic conditions. Using this combination allowed an increased number of injections at the maximal recommended dose.     

Adjuvant treatments associated with botulinum toxin injection for managing spasticity: An overview of the literature

Background and objectiveA wide range of adjunct therapies after botulinum toxin administration have been proposed. The aim of the present paper is to provide an overview of major writings dealing with adjuvant (non-pharmacological) treatments associated with botulinum toxin for managing spasticity in order to provide some up-to-date information about the usefulness of the most commonly used procedures.MethodsThe literature in PubMed was searched with the MeSH terms botulinum toxins, muscle spasticity, physical therapy modalities, and rehabilitation. The results were limited to studies focusing on adjuvant treatments associated with botulinum toxin for managing spasticity. We excluded papers on the use of non-drug treatments for spasticity not associated with botulinum toxin serotype A (BoNT-A) injection. Relevant literature known to the authors along with this complementary search represented the basis for this overview of the literature.ResultsAdhesive taping and casting effectively improved the botulinum toxin effect in patients with upper- and lower-limb spasticity. There is level 1 evidence that casting is better than taping for outcomes including spasticity, range of motion and gait. However, consensus about their most appropriate timing, duration, target and material is lacking. In terms of physical modalities combined with botulinum toxin injection, we found level 1 evidence that extracorporeal shock wave therapy is better than electrical stimulation for some post-injection outcomes including spasticity and pain. Furthermore, electrical stimulation of injected muscles might be useful to boost the toxin effect. However, the best stimulation protocol has not been defined. In addition, we found level 2b evidence that whole-body vibration therapy might reduce spasticity with cerebral palsy.ConclusionFuture research in this field should focus on investigating the most appropriate post-injection treatment protocol for each goal to achieve.     

Multiple sclerosis and botulinum toxin]

INTRODUCTION: The aim of this work was to collect litterature datas to have an indication of botulinum toxin in multiple sclerosis disease. METHOD: The international literature relating the years 1982-2002 was carried out with the Medline data bank. The article presenting of the controlled studies were mainly retained. RESULTS: Thirty-seven articles were indexed, 6 were retained according to our criteria. The selected articles show mainly a use of botulinum toxin in the spasticity. The principal criteria of evaluation were the muscular tone, the spasms, the pain, the or passive amplitude of joint.Two articles report the effectiveness of toxin injection in acquired nystagmus and the paralysis of a vocal fold. DISCUSSION: This review shows that the principal indication of toxin in multiple sclerosis is spasticity with a good effectiveness of the treatment. However controlled-placebo studies among these patients are still very few. The side effects are rare but sometimes appearance of muscular weakness always making discuss the existence of a push. It is necessary to take account of these effects and their consequences before proposing the treatment. CONCLUSION: Botulinum toxin has an indication in the treatment of spasticity of patients with multiple sclerosis. However more studies are necessary with more sits of injection to fix the good indications.     

肉毒毒素A对肌肉痉挛患者功能康复的作用

目的：探讨A型肉毒毒素（botulinum toxin type A，BTX—A）对上运动神经元损伤后肢体肌肉痉挛的治疗价值及其剂量影响。方法：选择48例上运动神经元损伤患者采用肉毒毒素A电刺激引导下局部肌肉注射治疗肌痉挛，其中把小腿三头肌、肱二头肌、屈指肌随机分成高低两个剂量组，观察剂量不同对疗效的影响，同时对所有患者制订注射后的目标，观察其达标情况。结果：肉毒毒素A注射后肌肉张力明显降低（P〈0．05），但在小腿三头肌、肱二头肌及屈指肌群中均未发现明显的量效关系，各配对大小剂量组肌张力评分差异无显著性意义（P〉0．05）；患者功能显著改善，康复目标总达标率为70．4％，肉毒毒素对上肢的粗大运动及下肢的步行功能的改善效果明显，而对手的精细活动功能的恢复效果欠佳。结论：肉毒毒素A对缓解上运动神经元损伤后的肢体肌肉痉挛，提高其生活自理能力及运动功能疗效显著，肉毒毒素作用的量效关系尚有待确认.     

Physical Medicine and Rehabilitation (88)

Managing spasticity in pediatric cerebral palsy using a very low dose of botulinum toxin type A: preliminary report. (Chulalongkorn University Hospital, Bangkok, Thailand) Am J Phys Med Rehabil 2000;79:320–326.
This study was conducted to determine if very low doses of botulinum toxin type A (BTX-A) could reduce spasticity and improve gait in cerebral palsied children when combined with rehabilitation therapy. The trainable (IQ> 80), ambulatory, spastic diplegic or hemiplegic cerebral palsied children, with no fixed contractures in at least one limb, were selected for this study. Patients with a score of 3 on a modified Ashworth scale received 0.5 units of BTX-A/kg/muscle. Patients with an Ashworth score of 4 received 1.0 BTX-A/kg/muscle. After BTX-A injection, all patients received rehabilitation therapy and plastic ankle and foot orthoses for walking. Both groups exhibited improvement in Ashworth score and in gait within 72 h of injection with botulinum toxin. Beneficial effects persisted for 10 to 12 months in most patients, with 3 patients exhibiting benefits for at least 20 months. Conclude that a very low dose of BTX-A combined with rehabilitation therapy resulted in a long-lasting decrease in spasticity and an improvement in gait in children with cerebral palsy.     

Managing spasticity in pediatric cerebral palsy using a very low dose of botulinum toxin type A: preliminary report

OBJECTIVE: To determine if very low doses of botulinum toxin type A (BTX-A) could reduce spasticity and improve gait in cerebral palsied children when combined with rehabilitation therapy. DESIGN: Ten trainable (IQ > 80), ambulatory, spastic diplegic or hemiplegic cerebral palsied children, with no fixed contractures in at least one limb, were selected for the study. Patients with a score of 3 on a modified Ashworth scale received 0.5 units of BTX-A/kg/muscle. Patients with an Ashworth score of 4 received 1.0 BTX-A/kg/muscle. After BTX-A injection, all patients received rehabilitation therapy and plastic ankle and foot orthoses for walking. RESULTS: Both groups exhibited improvement in Ashworth score and in gait within 72 hr of injection with botulinum toxin. Beneficial effects persisted for 10 to 12 mo in most patients, with three patients exhibiting benefits for at least 20 mo. CONCLUSIONS: The results of the present study indicate that a very low dose of botulinum toxin type A combined with'rehabilitation therapy resulted in a long-lasting decrease in spasticity and an improvement in gait in children with cerebral palsy.     

康复训练及A型肉毒毒素注射治疗脑卒中下肢肌痉挛

目的：探讨康复训练结合A型肉毒毒素（BTX-A）注射对脑卒中后下肢肌痉挛患者肌张力、运动功能及步行能力的影响。方法：选择32例下肢伸肌痉挛,改良Ashworth痉挛量表（MAS）评定2～3级的脑卒中患者,随机分为综合组及对照组各16例。2组患者均对下肢痉挛肌群进行分点注射BTX-A。综合组在注射24 h后结合康复训练,包括神经发育技术、物理疗法及运动疗法等。2组治疗前后采用MAS评定下肢肌张力及Fugl-Meyer运动量表（FMA）评定下肢运动功能;并进行步速和步长测定。结果：BTX-A注射后1、6及12周时,2组患者MAS评分明显下降,FMA评分明显上升,步速和步长明显提高（均P〈0.05）。2组间比较,综合组表现更明显（P〈0.05）。结论：康复训练结合BTX-A注射可以显著降低脑卒中痉挛肢体的肌张力,提高运动功能和步行能力。     

超声引导下的肩胛下肌外侧（腋下）入路肉毒毒素注射

目的:介绍超声引导下肩胛下肌外侧腋下入路肉毒毒素注射方法。方法:2例上肢偏瘫肩痛并有痉挛的患者,采用超声引导下外侧腋下入路注射肉毒毒素。结果:经注射治疗后,患者肩痛、上肢痉挛明显降低;主动和被动肩关节活动度均有提高。结论:某些深部肌肉注射肉毒毒素具有一定技术难度和风险。由于在超声引导下,深部肌肉可视并容易注射,注射具有安全性、有效性和经济性。     

A randomized controlled trial of botulinum toxin on lower limb spasticity following acute acquired severe brain injury

OBJECTIVE: To determine whether serial casting combined with botulinum toxin reduces the development of calf contracture after severe head injury. DESIGN: A double-blind placebo-controlled trial of three parallel treatments for lower limb spasticity. SETTING: Acute general hospital in the UK. SUBJECTS: Adults aged 17-70 years admitted to hospital following a severe brain INTERVENTIONS: Current physical treatment (group I), lower leg casting plus injections with either saline (group II), or with botulinum toxin (group III) into gastrocnemius and soleus muscles. MEASURES: Limit of ankle dorsiflexion at entry and exit after up to 12 weeks, the Glasgow Outcome Scale (GOS) and Modified Ashworth Scale (MAS). RESULTS: Two hundred and fifty-three patients were screened and 35 were entered into the trial. Three patients died and four failed to complete the trial. Eighty-eight per cent of those entering the randomized part of the study developed spasticity within 14 days of their injury and the mean range of improvement in the angle of passive ankle dorsiflexion was 4.59 degrees in controls, 11.69 degrees in cast and saline and 13.59 degrees in cast and botulinum toxin. There were significant improvements in the MAS scores in actively treated groups, but not in controls. Cast and botulinum toxin patients also demonstrated a significant improvement in the GOS. CONCLUSIONS: Active intervention with casting prevents talipes equinovarus deformities in patients losing ankle movement following severe brain injury. Casting alone in these patients is sufficient; the role of additional botulinum toxin needs further investigation, but is safe in these patients.     

BOTOX and physical therapy in the treatment of piriformis syndrome

OBJECTIVE: This study evaluates the efficacy of botulinum toxin A injections used in conjunction with physical therapy for the treatment of piriformis syndrome. DESIGN: This a double-blind, placebo controlled clinical trial using electrophysiologic criteria for patient selection and a visual analog scale to assess treatment efficacy in relieving pain. RESULTS: As measured on the visual analog scale, patients injected with botulinum toxin A experienced more relief from pain than patients receiving lidocaine with steroid (P < 0.05) and more relief than patients receiving placebo (P = 0.001). CONCLUSIONS: Injection with botulinum toxin A is an effective adjunct to physical therapy in the treatment of piriformis syndrome. H-reflex prolongation by flexion, adduction, and internal rotation (FAIR test) beyond 1.86 msec (3 SD) of the mean is a clinical indication of piriformis syndrome.