Posts Tagged botulinum toxins

[Abstract] Effectiveness of botulinum toxin treatment for upper limb spasticity after stroke over different ICF domains: a systematic review and meta-analysis.

Abstract

Objective

To provide a comprehensive overview of reported effects and scientific robustness of botulinum toxin (BoNT) treatment regarding the main clinical goals related to post-stroke upper limb spasticity, using the ICF classification.

Data sources

Embase.com, PubMed, Wiley/Cochrane Library, and Ebsco/CINAHL were searched from inception up to 16 May 2018.

Study Selection

Randomized controlled trials comparing upper limb BoNT injections with a control intervention in stroke patients were included. A total of 1212 unique records were screened by two independent reviewers. Forty trials were identified, including 2718 stroke patients.

Data Extraction

Outcome data were pooled according to assessment timing (i.e. 4-8 and 12 weeks after injection), and categorized into six main clinical goals (i.e. spasticity-related pain, involuntary movements, passive joint motion, care ability, arm and hand use, and standing and walking performance). Sensitivity analyses were performed for the influence of study and intervention characteristics, involvement of pharmaceutical industry, and publication bias.

Data Synthesis

Robust evidence is shown for the effectiveness of BoNT in reducing resistance to passive movement, as measured with the (Modified) Ashworth Score, and improving self-care ability for the affected hand and arm after intervention (p<0.005) and at follow-up (p<0.005). In addition, robust evidence is shown for the absence of effect on ‘arm-hand capacity’ at follow-up. BoNT significantly reduced ‘involuntary movements’, ‘spasticity-related pain’, and ‘carer burden’, and improved ‘passive range of motion’, while no evidence was found for ‘arm and hand use’ after intervention.

Conclusions

In view of the robustness of current evidence, no further trials are needed to investigate BoNT for its favourable effects on resistance to passive movement of the spastic wrist and fingers, and on self-care. No trials are needed to further confirm the lack of effects of BoNT on arm-hand capacity, whereas additional trials are needed to establish the suggested favourable effects of BoNT on other ‘body functions’ which may result in clinically meaningful outcomes at ‘activity’ and ‘participation’ levels.

via Effectiveness of botulinum toxin treatment for upper limb spasticity after stroke over different ICF domains: a systematic review and meta-analysis – Archives of Physical Medicine and Rehabilitation

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[Abstract] How effective is physical therapy for gait muscle activity in hemiparetic patients who receive botulinum toxin injections?

Abstract

BACKGROUND: Administration of botulinum neurotoxin A (BoNT-A) to the ankle plantar flexors in patients with hemiplegia reduces the strength of knee extension, which may decrease their walking ability. Studies have reported improvements in walking ability with physical therapy following BoNT-A administration. However, no previous studies have evaluated from an exercise physiology perspective the efficacy of physical therapy after BoNT-A administration for adult patients with hemiplegia.

AIM: To investigate the effects of physical therapy following BoNT-A administration on gait electromyography for patients with hemiparesis secondary to stroke.

DESIGN: Non-randomized controlled trial.

SETTING: Single center.

POPULATION: Thirty-five patients with chronic stroke with spasticity were assigned to BoNT-A monotherapy (N.=18) or BoNT-A plus physical therapy (PT) (N.=17).

METHODS: On the paralyzed side of the body, 300 single doses of BoNT-A were administered intramuscularly to the ankle plantar flexors. Physical therapy was performed for 2 weeks, starting from the day after administration. Gait electromyography was performed and gait parameters were measured immediately before and 2 weeks after BoNT-A administration. Relative muscle activity, coactivation indices, and walking time/distance were calculated for each phase.

RESULTS: For patients who received BoNT-A monotherapy, soleus activity during the loading response decreased 2 weeks after the intervention (P<0.01). For those who received BoNT-A+PT, biceps femoris activity and knee coactivation index during the loading response and tibialis anterior activity during the pre-swing phases increased, whereas soleus and rectus femoris activities during the swing phase decreased 2 weeks after the intervention (P<0.05). These rates of change were significantly greater than those for patients who received BoNT-A monotherapy (P<0.05).
CONCLUSIONS: Following BoNT-A monotherapy, soleus activity during the stance phase decreased and walking ability either remained unchanged or deteriorated. Following BoNT-A+PT, muscle activity and knee joint stability increased during the stance phase, and abnormal muscle activity during the swing phase was suppressed.

CLINICAL REHABILITATION IMPACT: If botulinum treatment of the ankle plantar flexors in stroke patients is targeted to those with low knee extension strength, or if it aims to improve leg swing on the paralyzed side of the body, then physical therapy following BoNT-A administration could be an essential part of the treatment strategy.

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via How effective is physical therapy for gait muscle activity in hemiparetic patients who receive botulinum toxin injections? – European Journal of Physical and Rehabilitation Medicine 2019 February;55(1):8-18 – Minerva Medica – Journals

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[ARTICLE] Intensive therapy after botulinum toxin in adults with spasticity after stroke versus botulinum toxin alone or therapy alone: a pilot, feasibility randomized trial – Full Text

Abstract

Background

Botulinum toxin-A is provided for adults with post-stroke spasticity. Following injection, there is a variation in the rehabilitation therapy type and amount provided. The purpose of this study was to determine if it is feasible to add intensive therapy to botulinum toxin-A injections for adults with spasticity and whether it is likely to be beneficial.

Methods

Randomized trial with concealed allocation, assessor blinding, and intention to treat analysis. Thirty-seven adults (n = 3 incomplete or lost follow-up) with spasticity in the upper or lower limb were allocated to one of three groups: experimental group received a single dose of botulinum toxin-A plus an intensive therapy for 8 weeks, control group 1 received a single dose of botulinum toxin-A only, and control group 2 received intensive therapy only for 8 weeks. Feasibility was measured by examining recruitment, intervention (adherence, acceptability, safety), and measurement. Benefit was measured as goal achievement (Goal Attainment Scale), upper limb activity (Box and Block Test), walking (6-min walk test) and spasticity (Tardieu scale), at baseline (week 0), immediately after (week 8), and at three months (week 12).

Results

Overall recruitment fraction for the trial was 37% (eligibility fraction 39%, enrolment fraction 95%). The 26 participants allocated to receive intensive rehabilitation attended 97% of clinic-based sessions (mean 11 ± 2 h) and an averaged 58% (mean 52 ± 32 h) of prescribed 90 h of independent practice. There were no study-related adverse events reported. Although participants in all groups increased their goal attainment, there were no between-group differences for this or other outcomes at week 8 or 12.

Conclusion

Providing intensive therapy following botulinum toxin-A is feasible for adults with neurological spasticity. The study methods are appropriate for a future trial. A future trial would require 134 participants to detect a between-group difference of 7 points on Goal Attainment Scale t-scores with an alpha of 0.05 and power of 80%.

Background

Spasticity affects approximately 20% of stroke survivors [14] and is thought to significantly contribute to falls after stroke [56] as well as decreased activity participation [34]. Unsurprisingly, higher costs are thus incurred by patients with spasticity during the first year of survival [7]. Health professionals identify that addressing spasticity is a high priority during rehabilitation [8], and there is international consensus that localized spasticity (i.e., in the upper or lower limbs) is best managed with a combination of botulinum toxin and physical therapy [910]. While these consensus papers appear to agree, clinical management remains diverse [1112] and provides an ongoing challenge for both therapists and health services alike.

In Australia, stroke rehabilitation is guided by the Stroke Foundation clinical practice guidelines [13]. These guidelines recommend that management of moderate to severe spasticity include the use of botulinum toxin type A in additionto physical therapy interventions [13]. Unfortunately, clinical survey data suggests that occupational therapists and physiotherapists report providing therapy post-botulinum toxin type A injections less than a quarter of the time (an estimated 16%) [12]. This low rate of therapy provision suggests ongoing uncertainty among clinicians as to how to treat patients with spasticity. Such uncertainty is likely to stem from the lack of research studies that describe the type, frequency, intensity, and duration of therapy that is effective for people who have received botulinum toxin injections. While there are previous studies which have tested the efficacy of botulinum toxin type A for spasticity management after stroke [1416], what remains unknown is whether or not therapy should be provided to this group of patients.

To inform best practice in the treatment and rehabilitation of spasticity in people with neurological conditions, understanding whether the suggested combined effects of using both therapy and botulinum toxin type A together is more beneficial than botulinum toxin-A alone or physiotherapy interventions alone is key. Given the lack of research in this area, a large, powered randomized controlled trial is required. In preparation for this trial, it is key to understand both the feasibility and likely effects of the interventions; therefore, the research questions posed in this pilot study were:

  1. In neurological patients with spasticity, is it feasible to add intensive therapy to botulinum toxin-A injections if the therapy includes both clinic-based and home-based therapy sessions?
  2. Is adding intensive therapy likely to be of any benefit to goal attainment, upper limb activity, walking, and spasticity over botulinum toxin-A alone or intensive therapy alone?[…]

Continue —> Intensive therapy after botulinum toxin in adults with spasticity after stroke versus botulinum toxin alone or therapy alone: a pilot, feasibility randomized trial

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[ARTICLE] Botulinum toxin type-A overdose for the treatment of spastic muscles in two patients with brain injuries – Full Text

Abstract

Spasticity is commonly encountered clinically, and always affects patients’ motor ability and capacity for self-care which necessitates intervention. At present, numerous methods have been proposed with varying effects. Many reports show that the most effective method is to inject botulinum toxin, type A (BTX-A) into the spasming muscles, but the doses are different. The guidline of BTX-A injection in Chinese adults is restricted to 600 IU each time within 3 months. In this article, we treated two brain injury patients with severe regional spasticity with overdose of China-making BTX-A whose trademark is HengLi. The treatment improved spasticity and with little adverse effects. We therefore conclude that overdoses of BTX-A could also be safe and more efficient used in some patients who are showing severe spasticity of limb muscles, but it should be vary with each individual and a large sample size trial is needed for a further confirmation.

Introduction

Spasticity often occurs after brain injury and always affects the motor ability and other function of the patient, thereby necessitating intervention in some cases. At present, the most effective method is injection of BTX-A in the spasming muscles. However, there is no unified guideline for the injection doses [1], the highest dosage for a single injection is less than 600 IU in Chinese guideline. So the most usage dose of BTX-A which injected to the spastic muscles of patient, was always 100-500 IU per time of per patient in our clinical work days, and sometimes it seems to take insufficient effects during a period of 2 weeks, the effect of BTA-A even last for more than 3 months.

So in patients with extensive or severe muscle spasm we decided to increase the dose of BTX-A. Although the halflethal dose of BTX-A is 40 IU/kg of body weight, which implies that a dose of BTX-A over 600 IU is safe, even a larger dose might be safe enough, but it is not confirmed yet, only few trials of small sample has been published, and the doses are less than that we used [2]. Thus, we tried administering higher BTX-A doses in two patients who had developed a severe regional spasticity after brain injury. To our knowledge, none of this kind of reports has been published yet.

Case Presentation

This study was conducted in accordance with the declaration of Helsinki, and it was conducted with approval from the Ethics Committee of the affiliated hospital of Qingdao University. Written informed consents were obtained from the participants. All procedures were performed with the consent of the patients and their family members.

Case 1

A 57-year-old man was admitted because of sudden glossolalia with choking and coughing while drinking, who was also unable to walk and swallow, had an over 10 years history of high blood pressure, but irregular use of antihypertensive agents. He was carried to our hospital for further rehabilitation after a preliminary treatment in a local hospital. Physical examination (PE) at admittance: BP 148/86 mmHg. The systolic pressure was a little higher, and his heart rate, rhythm and both the lungs were heard normal.

Nervous system examination (NSE): Although consciously, but the patient was anepia, depressed, and a little uncooperative on checking. His right nasolabial groove was relatively shallower, and poor tongue controlling. 0-1 grade muscle strength on his right side, and 3-4 grade on the left, increased muscle tone, and hyperactive tendon reflex, Modified Ashworth Scales (MAS) of both sides are range from 1+ to 2 grade. Right Babinski’s sign was positive (+), but the left was doubtful positive (±). Thus the patient was diagnosed as brain stem infarction. He was treated by kinesitherapy (occupational and physical training), and swallowing disorder treatment. After 2 weeks of rehabilitation, his sitting balance reached grade 2; He could stand up from bed with one person’s assistance, but could not take a step. He experienced difficulty in lifting his feet and obvious spasticity of his right limbs. His MAS for left elbow flexion muscle, right hamstring, and right triceps surae was grade 2, whereas his left triceps surae was grade 1+. After taking Tizanidine (an oral antispasmodic drug) for about one month, with the dose gradually increasing from 6 mg/d to 12 mg/d. However, there was appeared some unexpected symptoms, such as dizziness and/or sleepiness [3].

Thus we decided to administer a local injection of megadose of BTX-A in the severe spasming limb muscles. The right upper flexor muscles and the right lower limb were injected with 250 IU and 450 IU, respectively. We chose 5 muscles as the targets for injection:

  1. The adduction muscle
  2. Hamstring muscles

  3. Triceps surae

  4. Posterior tibial muscle

  5. And/or flexor digitorum longus

We used surface electrodes to detect the most contracted and sensitive parts of the muscles, marked on the surface then inserted needle electrodes deeply into the muscle to search for the appropriate motor points. Drug preparation: 100 U BTX-A was diluted with 2 ml normal saline to a final concentration of 50 U/ml. 4-6 injection points for a large muscle and 1-2 for small muscles were selected; each point injected 0.5-1 ml (25-50 U) BTX-A. After 4-10 days, the tone of the injected muscles was decreased, and gradually the patient could also stand and take steps in a stable condition. Two weeks to 3 months after injection both the patient’s Modified Ashworth Scale (MAS) and independent functional walking ability improved significantly, except a short period of mild weakness of muscle strength, there is no adverse effect occurred.

Cases 2

A 48-year old male was admitted to ICU 2 months after multiple traumatic injuries during a traffic accident. PE: Clearminded and spoke fluently, but high-level intelligence was impaired, especially the memory and orientation ability, and both of his eyes had limited abduction, hypopsia of counting fingers at a 60 cm distance. The muscle forces for both the upper limbs were grade 4 (MMT), moving with slight fibrillation. The proximal muscle force of the left leg was grade 2, whereas the distal level was 0. The right lower limb proximal muscle force was grade 1 and the distal was grade 0, with increased muscle tone of MAS grade, for the bilateral quadriceps were level 3, and the bilateral adductors were level 2-3. Magnetic resonance imaging (MRI) showed changes after the traumatic brain injury, including hydrocephalus. Thus the final diagnosis of the patient was “Brain injury, Multiple fractured ribs, Left femur fracture, and Acute suppurative myelitis”.

After routine rehabilitation therapy for 3 months, the patient’s sitting balance was restored to level 2. He could stand up and sit down with assistance. He could stand but could not move with walking aid. The bilateral iliopsoas muscle forces were 2-3 level. He could walk 3-5 meters on flat ground with the use of bandages and support from two persons. His hips showed obvious bilateral adduction leading to an atypical scissors gait, which made knee flexion and sitting difficult. He was given a little dose of Tizanidine firstly, however, Tizanidine administration was rapidly terminated because of its adverse effects, such as lethargy, low blood pressure [3]. BTX-A injection was then administered to his bilateral adductor muscles and quadriceps femoris at a final dose of 350 U each. The dilution and injection methods were the same as those described in Case 1. After 3-7 days of injection, we evaluated the patients’ lower limb muscles spasm degree [4]. The MAS was improved significantly, and the grade of functional walking ability improved at 2 and 4 weeks respectively after the injection, lasting more than 3 months.

Discussion

BTX-A has been used to treat muscle tension disease for more than 50 years, and it has been widely applied by now [510]. At present, BTX-A can be made in several countries including China. The commercial name of Chinese BTX-A is HengLi, each vial contents 100 U. BTX blocks the physiological function of cholinergic nerve conduction, especially at the muscle-nerve joints, thus causing voluntary muscle relaxation. BTX-A is one of the most toxic substances in the world. However, after nearly 50 years of clinical application, the safety of BTX-A has been fully demonstrated [11]. A halflethal dose of mankind is 40 IU/kg, but with a maximum permissible dose of 600 U being the Chinese domestic expert consensus in 2010. As a result, repeated injections may cause immune complex diseases, so repeated BTX-A injection within 3 months is prohibited, but repeated injections have been reported in a short term within 1 week. Repeated injection in a short term is not well understood, and therefore, we do not advocate this approach.

We report two cases with muscle spasms after brain injury, who were treated by injecting BTX-A. Both the injection doses exceed the maximum dose of the Expert Consensus but were far from the median lethal dose. In both cases, no adverse reactions occurred, and the treatment helped achieving better clinical effects than the alternatives, similar to that reported in previous studies [1214]. Overdosage of BTX-A can be more efficacy and safe enough, therefore, in our further clinical study, according to the individual need and economic characteristics of the patient, we should reasonably and individually adjust the doses of BTX-A to achieve the best therapeutic effect and more beneficial to the patients’ self-care ability.

References

Source: Botulinum toxin type-A overdose for the treatment of spastic muscles in two patients with brain injuries

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[Abstract] Efficacy and safety of botulinum toxin type A for upper limb spasticity after stroke or traumatic brain injury: a systematic review with meta-analysis.

Abstract

INTRODUCTION:

Muscle spasticity is a positive symptom after stroke and traumatic brain injury. Botulinum toxin type A (BoNT-A) injection is widely used for treating post stroke and traumatic brain injury spasticity. This study aimed to evaluate efficacy and safety of BoNT-A for upper limb spasticity after stroke and traumatic brain injury and investigate reliability and conclusiveness of available evidence for BoNT-A intervention.

EVIDENCE ACQUISITION:

We searched electronic databases from inception to September 10 of 2016. Randomized controlled trials comparing the effectiveness between BoNT-A and placebo in stroke or traumatic brain injury adults with upper limb spasticity were included. Reliability and conclusiveness of the available evidence were examined with trial sequential analysis.

EVIDENCE SYNTHESIS:

From 489 citations identified, 22 studies were included, reporting results for 1804 participants. A statistically significant decrease of muscle tone was observed at each time point after BoNT-A injection compared to placebo (SMD at week 4=-0.98, 95% CI: -1.28 to -0.68; I2=66%, P=0.004; SMD at week 6=-0.85, 95% CI: -1.11 to -0.59, I2=1.2%, P=0.409; SMD at week 8=-0.87, 95% CI: -1.15 to -0.6, I2=0%, P=0.713; SMD at week 12=-0.67, 95% CI: -0.88 to -0.46, I2=0%, P=0.896; and SMD over week 12=-0.73, 95% CI: -1.21 to -0.24, I2=63.5%, P=0.065).Trial sequential analysis showed that as of year 2004 sufficient evidence had been accrued to show significant benefit of BoNT-A four weeks after injection over placebo control. BoNT-A treatment also significantly reduced Disability Assessment Scale Score than placebo at 4, 6 and 12-week follow-up period (WMD=-0.33, 95% CI: -0.63 to -0.03, I2=60%, P=0.114; WMD=-0.54, 95% CI: -0.74 to -0.33, I2= 0%, P=0.596 and WMD=-0.3, 95% CI: -0.45 to -0.14, I2=0%, P=0.426 respectively), and significantly increased patients’ global assessment score at week 4 and 6 after injection (SMD=0.56, 95% CI: 0.28 to 0.83; I2=0%, P=0.681 and SMD=1.11, 95% CI: 0.4 to 1.77; I2=72.8%, P=0.025 respectively). No statistical difference was observed in the frequency of adverse events between BoNT-A and placebo group (RR=1.36, 95% CI [0.82, 2.27]; I2=0%, P=0.619).

CONCLUSIONS:

As compared with placebo, BoNT-A injections have beneficial effects with improved muscle tone and well-tolerated treatment for patients with upper limb spasticity post stroke or traumatic brain injury.

Source: Efficacy and safety of botulinum toxin type A for upper limb spasticity after stroke or traumatic brain injury: a systematic review with meta-analy… – PubMed – NCBI

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[ARTICLE] Influence of physician empathy on the outcome of botulinum toxin treatment for upper limb spasticity in patients with chronic stroke: A cohort study – Full Text

Abstract

Objective: To examine the relationship between patient-rated physician empathy and outcome of botulinum toxin treatment for post-stroke upper limb spasticity.

Design: Cohort study.

Subjects: Twenty chronic stroke patients with upper limb spasticity.

Methods: All patients received incobotulinumtoxinA injection in at least one muscle for each of the following patterns: flexed elbow, flexed wrist and clenched fist. Each treatment was performed by 1 of 5 physiatrists with equivalent clinical experience. Patient-rated physician empathy was quantified with the Consultation and Relational Empathy Measure immediately after botulinum toxin treatment. Patients were evaluated before and at 4 weeks after botulinum toxin treatment by means of the following outcome measures: Modified Ashworth Scale; Wolf Motor Function Test; Disability Assessment Scale; Goal Attainment Scaling.

Results: Ordinal regression analysis showed a significant influence of patient-rated physician empathy (independent variable) on the outcome (dependent variables) of botulinum toxin treatment at 4 weeks after injection, as measured by Goal Attainment Scaling (p < 0.001).

Conclusion: These findings support the hypothesis that patient-rated physician empathy may influence the outcome of botulinum toxin treatment in chronic stroke patients with upper limb spasticity as measured by Goal Attainment Scaling.

Introduction

Stroke is a leading cause of adult disability (1, 2). Damage to the descending tracts and sensory-motor networks results in the positive and negative signs of the upper motor neurone syndrome (UMNS) (1–3). The upper limb is commonly involved after stroke, with up to 69% of patients having arm weakness on admission to hospital (4). Recovery of upper limb function has been found to correlate with the degree of initial paresis and its topical distribution according to the cortico-motoneuronal representation of arm movements (5–9).

Spasticity is a main feature of UMNS. It is defined as a state of increased muscle tone with exaggerated reflexes characterized by a velocity-dependent increase in resistance to passive movement (10). Upper limb spasticity has been found to be associated with reduced arm function, low levels of independence and high burden of direct care costs during the first year post-stroke (11). It affects nearly half of patients with initial impaired arm function, with a prevalence varying from 17% to 38% of all patients at one year post-stroke (11). Up to 13% of patients with stroke need some form of spasticity treatment (drug therapy, physical therapy or other rehabilitation approaches) within 6–12 months post-onset (11, 12). Botulinum toxin type A (BoNT-A) has been proven safe and effective for reducing upper limb spasticity and improving arm passive function in adult patients (13, 14). While current literature reports highly patient-specific potential gains in function after BoNT-A treatment, there is inadequate evidence to determine the efficacy of BoNT-A in improving active function associated with adult upper limb spasticity (13).

Empathy refers to the ability to understand and share the feelings, thoughts or attitudes of another person (15). It is an essential component of the physician-patient relationship and a key dimension of patient-centred care (15, 16). This is even more important in rehabilitation medicine, where persons with disabilities often report encountering attitudinal and environmental barriers when trying to obtain rehabilitative care and express the need for better communication with their healthcare providers (17).

To the best of our knowledge, no previous research has investigated the influence of physician empathy on patient outcome after spasticity treatment. The aim of this study was to examine the relationship between patient-rated physician empathy and clinical outcome of BoNT-A treatment for upper limb spasticity due to chronic stroke. […]

Continue —> Journal of Rehabilitation Medicine – Influence of physician empathy on the outcome of botulinum toxin treatment for upper limb spasticity in patients with chronic stroke: A cohort study – HTML

 

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[Review] Systematic review of adjunct therapies to improve outcomes following botulinum toxin injection for treatment of limb spasticity.

Abstract

Objective: To determine the quality of evidence from randomized controlled trials on the efficacy of adjunct therapies following botulinum toxin injections for limb spasticity.

Data sources: MEDLINE, EMBASE, CINAHL, and Cochrane Central Register of Controlled Trials electronic databases were searched for English language human studies from 1980 to 21 May 2015.

Study selection: Randomized controlled trials assessing adjunct therapies postbotulinum toxin injection for treatment of spasticity were included. Of the 268 studies screened, 17 met selection criteria.

Data extraction: Two reviewers independently assessed risk of bias using the Physiotherapy Evidence Database (PEDro) scale and graded according to Sackett’s levels of evidence.

Data synthesis: Ten adjunct therapies were identified. Evidence suggests that adjunct use of electrical stimulation, modified constraint-induced movement therapy, physiotherapy (all Level 1), casting and dynamic splinting (both Level 2) result in improved Modified Ashworth Scale scores by at least 1 grade. There is Level 1 and 2 evidence that adjunct taping, segmental muscle vibration, cyclic functional electrical stimulation, and motorized arm ergometer may not improve outcomes compared with botulinum toxin injections alone. There is Level 1 evidence that casting is better than taping, taping is better than electrical stimulation and stretching, and extracorporeal shock wave therapy is better than electrical stimulation for outcomes including the Modified Ashworth Scale, range of motion and gait. All results are based on single studies.

Conclusion: There is high level evidence to suggest that adjunct therapies may improve outcomes following botulinum toxin injection. No results have been confirmed by independent replication. All interventions would benefit from further study.

 

Source: Systematic review of adjunct therapies to improve outcomes following botulinum toxin injection for treatment of limb spasticity

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[ARTICLE] Randomized, placebo-controlled trial of incobotulinumtoxinA for upper-limb post-stroke spasticity

Cover image for Vol. 52 Issue 2Abstract

Introduction: Efficacy and safety of incobotulinumtoxinA in post-stroke upper-limb spasticity were studied.

Methods: Subjects randomized 2:1 to incobotulinumtoxinA (fixed dose 400U) or placebo, with fixed doses for the primary target clinical pattern (PTCP; flexed elbow:200U; flexed wrist:150U; clenched fist:100U). Doses for non-primary patterns were flexible within predefined ranges.

Results: At Week-4, incobotulinumtoxinA led to larger improvements in PTCP Ashworth Scale (AS) scores than placebo [least squares mean change±standard error: −0.9±0.06 (n=171) versus −0.5±0.08 (n=88); P<0.001], and more subjects were PTCP AS responders (≥1-point improvement) with incobotulinumtoxinA (69.6%) than placebo (37.5%; P<0.001). Investigator’s Global Impression of Change confirmed superiority of incobotulinumtoxinA versus placebo (P=0.003). IncobotulinumtoxinA was associated with functional improvements, demonstrated in responder rates for Disability Assessment Scale principal target at Week-4 (P=0.007). Adverse events were mainly mild/moderate, and were reported by 22.4% (incobotulinumtoxinA) and 16.8% (placebo) subjects.

Conclusions: IncobotulinumtoxinA significantly improved upper-limb spasticity and associated disability, and was well-tolerated. This article is protected by copyright. All rights reserved.

via Randomized, placebo-controlled trial of incobotulinumtoxinA for upper-limb post-stroke spasticity – Elovic – Muscle & Nerve – Wiley Online Library.

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[Review] Systematic review of adjunct therapies to improve outcomes following botulinum toxin injection for treatment of limb spasticity

Abstract

Objective: To determine the quality of evidence from randomized controlled trials on the efficacy of adjunct therapies following botulinum toxin injections for limb spasticity.

Data sources: MEDLINE, EMBASE, CINAHL, and Cochrane Central Register of Controlled Trials electronic databases were searched for English language human studies from 1980 to 21 May 2015.

Study selection: Randomized controlled trials assessing adjunct therapies postbotulinum toxin injection for treatment of spasticity were included. Of the 268 studies screened, 17 met selection criteria.

Data extraction: Two reviewers independently assessed risk of bias using the Physiotherapy Evidence Database (PEDro) scale and graded according to Sackett’s levels of evidence.

Data synthesis: Ten adjunct therapies were identified. Evidence suggests that adjunct use of electrical stimulation, modified constraint-induced movement therapy, physiotherapy (all Level 1), casting and dynamic splinting (both Level 2) result in improved Modified Ashworth Scale scores by at least 1 grade. There is Level 1 and 2 evidence that adjunct taping, segmental muscle vibration, cyclic functional electrical stimulation, and motorized arm ergometer may not improve outcomes compared with botulinum toxin injections alone. There is Level 1 evidence that casting is better than taping, taping is better than electrical stimulation and stretching, and extracorporeal shock wave therapy is better than electrical stimulation for outcomes including the Modified Ashworth Scale, range of motion and gait. All results are based on single studies.

Conclusion: There is high level evidence to suggest that adjunct therapies may improve outcomes following botulinum toxin injection. No results have been confirmed by independent replication. All interventions would benefit from further study.

via Systematic review of adjunct therapies to improve outcomes following botulinum toxin injection for treatment of limb spasticity.

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