A型肉毒毒素对意识障碍患者上肢严重肌痉挛的应用价值

目的:探讨A型肉毒毒素局部注射在治疗意识障碍患者上肢严重肌痉挛的应用价值。方法:18例意识障碍患者上肢严重肌痉挛,应用A型肉毒毒素局部注射痉挛肌肉,以改良Ashworth量表(MAS)比较上肢肌张力在治疗前和治疗后1周、4周、12周改善程度,同时以照料者主观评价三项护理任务(穿衣、清洁手掌及剪指甲)完成的难易程度来评定临床功能性目标改善程度。结果:注射A型肉毒毒素治疗后上肢肌痉挛程度明显减轻,屈肘肌MAS评分在治疗前与治疗后1周、4周及12周相比差异有显著性意义(4.17±0.39;2.39±0.99;2.04±0.98;2.0±1.04;P<0.01)。屈掌指肌改良Ashworth量表评分在治疗前与治疗后1周、4周及12周相比差异有显著性意义(4.0;2.22±0.83;1.89±0.78;2.0±0.87,P<0.01)。照料者主观评价任务评分在治疗前(穿衣0.83±0.39,清洁手掌剪指甲1.0)与治疗后1周(分别为2.52±0.95,2.56±0.88),4周(分别为2.78±0.95,2.78±1.09),12周(分别为2.96±0.93,2.67±1.12)相比差异有显著性意义(P<0.01)。所有患者没有发现明显不良反应。结论:局部注射A型肉毒毒素能有效缓解意识障碍患者的上肢肌痉挛,便于患者的护理和卫生,减少相关并发症发生,有利于患者的康复,具有一定的临床应用价值。     

Taping versus electrical stimulation after botulinum toxin type A injection for wrist and finger spasticity. A case-control study

OBJECTIVE: To compare results from two approaches used in conjunction with botulinum toxin type A administration in rehabilitation: the application of a taping system and the electrical stimulation of the injected muscles and splinting. DESIGN: Case-control study. SETTING: Two tertiary care rehabilitation hospitals in Italy. SUBJECTS: Sixty-five adult subjects affected by spasticity of the wrist and finger flexors. INTERVENTIONS: After injection with botulinum toxin type A, the group at hospital A (n=33) was treated with adhesive taping for six days and those at hospital B (n=32) with electrical stimulation and splinting for six days. Spastic hypertonia at the injected muscles was assessed before treatment, one week and one month post injection. MAIN MEASURES: Modified Ashworth Scale. RESULTS: In group A, the mean Modified Ashworth Scale reduction was 2.76 +/- 0.94 for wrist flexors and 2.45 +/- 0.92 for finger flexors; in group B the mean Modified Ashworth Scale reduction was 2.18 +/- 1.11 for wrist flexors and 2.1 +/- 0.98 for finger flexors. The observed difference between the two groups was statistically relevant (p < 0.05). CONCLUSIONS: Patients treated with adhesive taping and botulinum toxin type A achieved a greater reduction in spastic hypertonia as measured with Modified Ashworth Scale, with less time dedicated for the treatment.     

Botulinum toxin in upper limb spasticity after acquired brain injury: a randomized trial comparing dilution techniques

OBJECTIVE: To compare the efficacy of two different volume preparations of the same dose of botulinum toxin-A in relieving spasticity in wrist and finger flexors secondary to acquired brain injury. DESIGN: Thirteen adult patients who had modified Ashworth scale scores of 3 for both wrist and finger flexors were included in this randomized, controlled trial. Wrist and finger flexors were each injected. Blinded modified Ashworth scale ratings of wrist and finger flexor spasticity were measured. RESULTS: Spasticity in both muscles decreased significantly in both treatment groups. However, the high-volume and low-volume groups did not differ significantly in spasticity reduction. CONCLUSIONS: Because this preliminary study found no difference in spasticity reduction between high- and low-volume preparations of a 60-unit dose of botulinum toxin-A, a larger-sample study seems warranted to compare the efficacy of high-volume and low-volume preparations.     

超声弹性成像在脑卒中后前臂屈肌痉挛定量评价中的应用

目的探讨应用超声弹性成像技术定量评价脑卒中后前臂屈肌痉挛的可行性及其特点。方法2019年1月至10月,脑卒中后屈腕和屈指肌痉挛的住院患者30例,采用超声弹性成像测量前臂屈肌群桡侧腕屈肌(FCR)、尺侧腕屈肌(FCU)、指浅屈肌(FDS)和指深屈肌(FDP)剪切波速度(SWV),采用改良Ashworth量表(MAS)评定屈腕和屈指肌张力。结果患侧和健侧各肌肉SWV在牵伸位时均显著高于放松位(|Z|>3.844,P<0.001);牵伸位时,患侧各肌肉SWV显著高于健侧(|Z|>3.593,P<0.001);牵伸位与放松位SWV差值比较,患侧各肌肉明显高于健侧(t>3.199,P<0.01);各肌肉牵伸位平均SWV与屈腕MAS评分显著相关(r=0.605,P<0.001);指浅屈肌和与指深屈肌牵伸位平均SWV与屈指MAS评分明显相关(r=0.540,P<0.01)。结论超声弹性成像可以定量评价脑卒中后前臂屈肌群内不同肌肉的痉挛程度。     

Changes in movement characteristics of the spastic upper extremity after botulinum toxin injection

OBJECTIVE: To examine the longitudinal effects of botulinum toxin injection on movement characteristics of the spastic upper extremity in children by using motor control testing (MCT) techniques and standard clinical measures. DESIGN: Open-label clinical trial. SETTING: Motor control laboratory at an academic medical center. PARTICIPANTS: A convenience sample of 9 subjects (5 boys, 4 girls; age range, 7-16 y) with cerebral injury (stroke or cerebral palsy) and asymmetric upper-extremity function because of spasticity. Eight subjects had right-sided involvement. INTERVENTIONS: Botulinum toxin injection to the involved upper extremity, involving elbow, wrist, and finger flexors, depending on clinical presentation. MAIN OUTCOME MEASURES: Clinical measures included range of motion (ROM), the Ashworth Scale, FIM trade mark instrument, Pediatric Evaluation of Disability Inventory, portions of the Bruininks-Oseretsky Test of Motor Proficiency, and the Purdue pegboard. MCT consisted of visually guided reaching, bilateral finger-to-nose movements, hand tapping, and isometric pinch force tasks. Kinematic assessments were made before and at 2, 4, 6, 12, 18, and 24 weeks after botulinum toxin injection. RESULTS: All subjects had increased ROM and decreased Ashworth values throughout the testing period. In motor control tasks, improvement typically occurred earlier in the least complex movements, such as hand tapping, with 6 of 9 subjects showing a maximum, although transient, unilateral tapping speed by 6 weeks. A similar time course was observed for pinch force tasks. Improvement in more complex, forward-reaching tasks occurred much later (week 12 or later) or did not occur at all. As with the hand tasks, improved reach performance declined toward the end of the testing period. All subject showed minimal or no improvement in bilateral finger-to-nose movements. Neither maximum changes in ROM or Ashworth values correlated with improvements in functional elbow extension during sit and reach tasks, with 3 subjects with normal active ROM showing late onset or no change in reach. CONCLUSIONS: Although botulinum toxin reduced tone and increased ROM of the spastic upper extremity, the time course and degree of motor improvement appears to depend on the complexity of the task. Future research should focus on the value of adjunct therapy, such as task-specific training, in addition to botulinum toxin treatments to facilitate functional improvement of the spastic upper extremity.     

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.     

Application of combined botulinum toxin type A and modified constraint-induced movement therapy for an individual with chronic upper-extremity spasticity after stroke

BACKGROUND AND PURPOSE: Constraint-induced movement therapy (CIMT) is a promising intervention for retraining upper-extremity function after a stroke. The purpose of this case report is to describe the use of a combination of botulinum toxin type A (BtxA) and a modified CIMT program for a patient with severe spasticity who was unable to use his right upper extremity. CASE DESCRIPTION: The 52-year-old patient, who had a stroke 4 years ago, did not meet the minimum motor criteria for CIMT benefit. After receiving BtxA injections targeting the elbow, wrist, and finger flexors, he completed a 4-week program of modified CIMT followed by a 5-month home exercise program. OUTCOMES: The patient exhibited improvement in muscle tone (the velocity-dependent resistance to stretch that muscle exhibits) and in scores on several upper-extremity function tests (Modified Ashworth Scale, Motor Activity Log, Wolf Motor Function Test, Action Research Arm Test, and Fugl-Meyer Assessment of Motor Recovery). He also reported making much progress in the functional use of the involved upper extremity. DISCUSSION: In a patient with severe flexor spasticity and nonuse of the dominant upper extremity after a stroke, a combined treatment of BtxA and modified CIMT may have resulted in improved upper-extremity use.     

Effect of intramuscular botulinum toxin injection on upper limb spasticity in stroke patients

OBJECTIVE: To evaluate the therapeutic effect of intramuscular injection of botulinum toxin on spasticity of the upper limb, with emphasis on its influence over limb function. DESIGN: An open-label, noncontrolled trial with a duration of 12 wk was designed to determine the safety and efficacy of intramuscular botulinum toxin A injection in the treatment of 16 patients with stroke with spastic hemiparesis. Electromyographically guided intramuscular botulinum toxin A injections were applied to the spastic limbs. A detailed scale system was used for the evaluation of muscle tone and functional changes induced by botulinum toxin A treatment. RESULTS: No major side effect secondary to botulinum toxin A injection was reported. Statistically significant (P < 0.05) improvements of muscle tone, joint range of motion, hand muscle strength, and muscular pain were seen after the injection. The improvements lasted up to 8-12 wk after the treatment. However, there was no significant functional improvement except in two of the patients. CONCLUSIONS: Botulinum toxin A injection may help relieve upper limb spasticity and pain in patients with stroke. Its effect on function is probably determined by case selection.     

Modified constraint-induced therapy and botulinum toxin A: a promising combination

Modified constraint-induced therapy and chemodenervation with botulinum toxin A are each efficacious in managing stroke-induced motor disorders; however, the application of these two promising modalities in combination is yet to be examined. This case study describes a 44-yr-old man who experienced a right middle cerebral artery infarct 14 mo before participating in modified constraint-induced therapy. After modified constraint-induced therapy completion, the patient exhibited substantial improvement in affected upper limb use and function but retained difficulty with finger extension secondary to hypertonicity and spasticity in the forearm flexor muscles. Selective chemodenervation of these muscles with botulinum toxin A greatly improved the patient's self-reported hand function and his scores using objective measures. The authors of this paper present this case to raise the idea of increasing treatment efficacy by combining these two modalities.     

Long-term effects of combined botulinum toxin treatment and rehabilitation on upper limb muscle spasms: a case report

[Purpose] We report our experience with a patient with a central spinal cord injury who showed improved finger and upper limb functions after long-term treatment with a combination of rehabilitation and botulinum toxin type A. [Participants and Methods] The patient had spasms and pain that gradually became more profound and was given botulinum toxin type A at 1 year 3 months after sustaining a spinal cord injury. We administered 14 botulinum toxin type A injections periodically for 7 years 4 months after the injury. We administered the injections at an average interval of 5.6 months. Splints that allowed extension and improved finger muscle tone and contracture were made for the patient. [Results] The patient experienced gradual alleviation of the spasms in the proximal upper limb muscles and improved range of motion after receiving five doses of botulinum toxin type A. The spasms and range of motion in the fingers gradually improved around 4 years after the injury through splint therapy and a combination of botulinum toxin type A administration and rehabilitation. [Conclusion] The combination of botulinum toxin type A, splint, and rehabilitation therapies can lead to positive improvements in finger spasticity and range of motion and is recommended for hypertonia cases with severe contractures.Key words: Carry-over effect, Concomitant use of splint, Restoration of hand function     

Dose-dependent response to intramuscular botulinum toxin type A for upper-limb spasticity in patients after a stroke

OBJECTIVE: To test the hypothesis that intramuscular (IM) botulinum toxin type A (BTX) reduces excessive muscle tone in a dose-dependent manner in the elbow, wrist, and fingers of patients who experience spasticity after a stroke. DESIGN: Randomized, double-blind, placebo-controlled, multicenter, 24-week trial. SETTING: Six academic and 13 private US outpatient medical centers. PARTICIPANTS: Ninety-one patients with a mean age of 60 years (range, 30-79 y). Mean time elapsed from ischemic or hemorrhagic stroke to study enrollment was 25.8 months (range, 0.9-226.9 mo). INTERVENTIONS: Up to 2 treatments of placebo, or 90, 180, or 360U of BTX. Concurrent splinting and physical therapy protocols were permitted, but no changes were allowed during the study. MAIN OUTCOME MEASURES: Wrist, elbow, and finger flexor tone assessed by the Modified Ashworth Scale, physician and patient global assessments, pain, FIM instrument, and Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). RESULTS: Muscle tone decreased more with injections of BTX than with placebo in the wrist flexors at weeks 1, 2, 3, 6, and 9 (P< or =.026); in the elbow flexors at weeks 1, 2, 3, 4, 5, and 9 (P< or =.033); and in the finger flexors at weeks 1 and 3 (P< or =.031). A dose-dependent response was generally observed in tone reduction but not in pain, FIM, or SF-36 measures. CONCLUSIONS: IM BTX reduced muscle tone in a dose-dependent manner in the elbow, wrist, and fingers of patients who experience spasticity after a stroke but did not appear to affect global quality of life or disability.     

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。     

Post stroke hemiplegia: lower limb benefit from botulinum toxin (review)]

OBJECTIVE: To clarify the conditions governing the use of botulinum toxin (BTX) for post-stroke lower limb spastic disorders: indications, choice of muscles, doses, and duration of efficacy. METHOD: Review of the international literature using the Medline and the Reedoc data banks. RESULTS: Seven controlled studies were reviewed, including in particular 2 studies vs placebo and one vs phenol, 7 open studies or case series closely related to this topic and 4 open studies partly dedicated to it. The usefulness of BTX for the treatment of equinovarus has been demonstrated. The main muscles to be treated are the soleus, gastrocnemius and tibialis posterior. The treatment proposed for toe clawing is BTX injection into the flexor digitorum longus and flexor hallucis longus, and for great toe permanent extension, injection of the extensor hallucis longus. The quadriceps femoris, the tibialis anterior or the hamstrings have only be treated in isolated cases. When the treatment is effective, its benefit may last for more than 6 months. DISCUSSION: A few controlled trials have demonstrated the efficacy of BTX for post stroke lower limb spasticity. The results of all the controlled and open trials argue in favor of its efficacy, but this still requires more thorough analysis. CONCLUSION: Botulinum toxin has a place together with other local treatments for post-stroke spasticity, but a precise guide to its use, especially its dosage, and it's effectiveness compared to that of other treatments, need further study.     

Botulinum toxin type B in upper-limb poststroke spasticity: a double-blind, placebo-controlled trial

OBJECTIVE: To determine whether botulinum toxin type B (BTX-B) is effective in controlling upper-limb spasticity. DESIGN: A single-site, double-blind, placebo-controlled, randomized trial and open-label study. SETTING: Outpatient. PARTICIPANTS: Subjects with an Ashworth Scale score of 2 or more at the elbow, wrist, and fingers. INTERVENTIONS: Subjects were injected with 10000 U of BTX-B or placebo at the elbow, wrist, and finger flexors.Main outcome measures Measures recorded at weeks 0, 2, 4, 8, 12, and 16, with a 12-week open-label study. Ashworth Scale score, a global assessment of change (GAC), adverse events and mouse neutralization antibody testing. RESULTS: BTX-B did not decrease muscle tone in the elbow, wrist, or finger flexors at 10000 U over the 16-week period. A decrease in Ashworth Scale score for the BTX-B patient group was present at the wrist at week 2 of the double-blind study (P=.003) but was not statistically significant at other visits. In the open-label study, improvement was noted at week 4 for the elbow (P=.039), wrist (P=.002), finger (P=.001), and thumb flexors (P=.002). In the double-blind study, the Physician GAC did not reach significance. Dry mouth was reported by 8 of 9 BTX-B subjects in the double-blind study. Mouse neutralization antibodies were negative. CONCLUSIONS: Our study does not show a significant decrease in tone from 10000 U of BTX-B. Dry mouth was common.     

Effects of botulinum toxin type A on upper limb function in children with cerebral palsy: a systematic review

OBJECTIVE: To evaluate whether botulinum toxin type A injections improve upper limb function in children with cerebral palsy. METHODS: An extensive search was carried out in PUBMED, CINAHL, PICARTA, EMBASE, PEDRO and the Cochrane Controlled Trials Register. Controlled and uncontrolled studies were included and evaluated on the basis of a best evidence synthesis. RESULTS: Twelve out of 645 identified studies were included: three randomized controlled trials (RCTs) (N=64) of high methodological quality, and nine uncontrolled studies (N=107) of sufficient methodological quality. In one of the three RCTs a short-term, significant decrease of spasticity was found in favour of the botulinum toxin type A group, which was supported by five of the seven uncontrolled studies that also measured spasticity. In one RCT significant changes in range of motion were reported for wrist and thumb extension. This finding was supported by two out of seven uncontrolled studies. One RCT reported a significant improvement in activities after one month, according to the Quality of Upper Extremity Skills Test and the Pediatric Evaluation Disability Inventory, whereas five out of the nine uncontrolled studies reported an improvement in functional activities. CONCLUSION: Insufficient evidence is found for the effects of botulinum toxin type A injections to reduce spasticity or to increase range of motion and upper limb function in children with cerebral palsy. Besides differences in treatment goals, the lack of evidence is mainly due to the use of invalid assessment instruments and insufficient statistical power to demonstrate treatment effects.     

Treatment with botulinum toxin type B for upper-limb spasticity

OBJECTIVE: To determine if botulinum toxin type B (MyoBloc) decreases spasticity. DESIGN: Investigator-initiated trial, open-label, single-treatment session. SETTING: Single site. PARTICIPANTS: Ten patients with stable upper-limb spasticity and an Ashworth Scale score of 2 or higher at the elbow, wrist, and fingers. INTERVENTIONS: Total dose of 10,000U of botulinum toxin type B injected into 5 major muscles. MAIN OUTCOME MEASURES: The Ashworth Scale, goniometry, and functional assessments were performed at injection and weeks 4, 8, and 12. The principal investigator (PI) global assessment of change (GAC) and the patient GAC were done at weeks 4, 8, and 12 postinjection. The safety of the procedure was measured by adverse events and vital signs. RESULTS: Improvements in Ashworth Scale scores were observed at weeks 4, 8, and 12 postinjection. At week 4, the mean changes (in Ashworth score) were elbow, -1.0 (P=.016); wrist, -1.7 (P=.004); finger, -1.35 (P=.02); at week 8: elbow, -.83 (P=.016); wrist, -1.00 (P=.016); finger, -.94 (P=.08); and at week 12: elbow, -.61 (P=.07); wrist, -1.00 (P=.016); and finger, -.89 (P=.10). The PI GAC improved at all visits. Nine of the 10 subjects reported dry mouth at week 4, with resolution by week 12. No changes were seen on the functional measures. CONCLUSIONS: Botulinum toxin type B may be useful in treatment of spasticity.     

A型肉毒素局部注射对脑卒中后痉挛性上肢功能障碍的影响

目的评估A型肉毒毒素(BTX-A)局部注射对脑卒中后痉挛性腕及手功能障碍的影响。方法 36例患者于治疗前及治疗后1周、4周、8周和12周应用改良Ashworth量表(MAS)、Carroll上肢功能试验(UEFT)、肢体静息位置、疼痛视觉模拟评分(VAS)、改良Barthel指数(MBI)、上肢3个运动任务(清洗偏瘫侧的手掌、剪患侧手指甲、将患侧的手臂伸进袖子)中遇到的困难进行评估。结果治疗后,MAS、VAS、UEFT评分和3个上肢任务完成情况均有改善(P<0.05),改善于注射后1周出现,并至少维持12周。MBI与治疗前比较无显著性差异(P>0.05)。结论 BTX-A局部注射可以改善脑卒中后痉挛性上肢功能障碍,减轻疼痛。     

Serial injection of botulinum toxin for muscle imbalance due to regional spasticity in the upper limb

BACKGROUND AND PURPOSE: Three-dimensional movement in the upper limb presents a challenge for functional management of regional spasticity. Potential toxicity of botulinum toxin limits the number of muscles which may be injected in any one session. Serial injection may offer a solution, but carries theoretical risk of development of resistance due to antibody formation. This article reviews a small case series, gathered in a post-acute neuro-rehabilitation setting, to evaluate the use of serial botulinum toxin injection in terms of goal achievement and clinical evidence for toxicity or resistance. METHODS: Nine patients with regional spasticity following acute stroke or brain injury had serial injection of botulinum toxin to muscle groups around the shoulder, elbow and/or wrist. Injection was followed by splinting/physiotherapy as appropriate. Goal attainment scaling was used to assess outcome. RESULTS: Functional goals achieved were reduction of pain (n=6/7) associated reaction (n=4/5) or care needs (n=5/6), improved gait (n=2/3) or independence in self-care (n=2/5). Two 'golden responder' cases are presented in detail to demonstrate resolution of symptoms with up to four serial injections of botulinum toxin over a period of up to 6 months. No clinical evidence of toxicity or resistance was seen in any case. CONCLUSION: These preliminary findings suggest that serial botulinum toxin injection followed by appropriate physiotherapy/splinting may provide effective treatment for regional spasticity. Resistance has not presented a problem in this post-acute situation, where treatment has not been required beyond a few months. Ongoing evaluation is underway.     

Flexor muscle incursion into the carpal tunnel: a mechanism for increased carpal tunnel pressure?

PURPOSE: To explore the hypothesis that the extrinsic finger flexor muscles have the potential to move into the proximal end of the carpal tunnel with wrist extension. METHODS: The most distal muscle fibres from the deep and superficial finger flexors were measured relative to the pisiform bone in 18 cadaveric specimens. Muscle excursions during wrist extension were calculated using regression equations previously reported in the literature. RESULTS: The mean distances from the pisiform were 9.3 and 4.9 mm for the deep and superficial flexors, respectively. Ten flexor muscle bellies were at the level of or distal to the pisiform bone in the anatomical position, while 17 of 36 were within 5 mm. DISCUSSION: The excursions expected with wrist extension indicate that many muscles have the potential to enter the carpal tunnel, especially those within 5 mm of the pisiform bone. Comparing the expected excursions to recent pressure data, corroborating support for the pressure increase is found. CONCLUSION: Although not directly measured, the results of this study indicate incursion of the flexor muscles into the carpal tunnel space, particularly with wrist extension, is a plausible mechanism for increased carpal tunnel pressure. RELEVANCE: Proposing a mechanism by which carpal tunnel pressure is elevated during wrist and finger extension is a stepping stone to determining the etiology of the disease itself. Finding that the flexor muscle bellies appear to enter the carpal tunnel with wrist extension indicates that use of the flexor muscles should be avoided when the wrist and fingers are extended.     

Botulinum Toxin Type B in the Spastic Arm: A Randomized,Double-Blind,Placebo-Controlled,Preliminary Study

Objective

To determine the efficacy and safety of 2 doses of botulinum toxin type B (rimabotulinumtoxinB, BoNT/B) in spastic upper limb muscles.

Design

Randomized, double-blind, placebo-controlled trial with a 3-month follow-up.

Setting

Tertiary care center.

Participants

Referred sample of adult hemiparetic patients (N=24) with disabling elbow flexor overactivity after stroke or traumatic brain injury.

Interventions

Injection of 10,000U of rimabotulinumtoxinB (fixed 2500U dose into elbow flexors; n=8), 15,000U (5000U into elbow flexors; n=8), or placebo (n=8) into overactive upper limb muscles selected as per investigator's discretion.

Main Outcome Measures

At 1 month postinjection, active range of elbow extension (goniometry; primary outcome); active upper limb function (Modified Frenchay Scale [MFS]); subjective global self-assessment (GSA) of arm pain, stiffness, and function; rapid alternating elbow flexion-extension movement frequency over the maximal range; elbow flexor spasticity grade and angle (Tardieu), and tone (Ashworth).

Results

No adverse effects were associated with either BoNT/B dose. Both doses improved active elbow extension versus placebo (+8.3°; 95% confidence interval, 1.1°–15.5°; analysis of covariance, P=.028). The high dose of BoNT/B also improved subject-perceived stiffness (P=.005) and the composite pain, stiffness, and function GSA (P=.017), effects that persisted 3 months from injection. No MFS change was demonstrated, although subjects with a baseline MFS <70/100 seemed more likely to benefit from BoNT/B.

Conclusions

In this short-term study, BoNT/B up to 15,000U into spastic upper limb muscles, including the elbow flexors, was well tolerated and improved active elbow extension and subject-perceived stiffness.