Posts Tagged botulinum toxin

[ARTICLE] ADULT SPASTICITY INTERNATIONAL REGISTRY STUDY: METHODOLOGY AND BASELINE PATIENT, HEALTHCARE PROVIDER, AND CAREGIVER CHARACTERISTICS – Full Text PDF

Objective: The main aim of this study was to determine
the utilization patterns and effectiveness of onabotulinumtoxinA (Botox®) for treatment of spasticity in clinical practice.

Design: An international, multicentre, prospective, observational study at selected sites in North America, Europe, and Asia.

Patients: Adult patients with newly diagnosed or established focal spasticity, including those who had previously received treatment with onabotulinumtoxinA.

Methods: Patients were treated with onabotulinumtoxinA, approximately every 12 weeks, according to their physician’s usual clinical practice over a period of up to 96 weeks, with a final follow-up interview at 108 weeks. Patient, physician and caregiver data were collected.

Results: Baseline characteristics are reported. Of the 745 patients enrolled by 75 healthcare providers from 54 sites, 474 patients had previously received onabotulinumtoxinA treatment for spasticity. Lower limb spasticity was more common than upper limb spasticity, with stroke the most common underlying aetiology. The Short-Form 12 (SF-12) health survey scores showed that patients’ spasticity had a greater perceived impact on physical rather than mental aspects.

Conclusion: The data collected in this study will guide the development of administration strategies to optimize the effectiveness of onabotulinumtoxinA in the management of spasticity of various underlying
aetiologies.

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[Abstract] Combined Effect Of Botulinum Toxin And Splinting On Motor Components And Function Of People With Stroke  

Abstract

Background and objective: Spasticity is one of the problems following stroke. Due to this increase in muscle tone, patients are confronted to problems in motor control and difficulties in activities of daily living and complications such as shortness and contracture. The aim of this study was to examine the effects of Simultaneous use of both splint and botulinum toxin-A (BTX-A) injection on spasticity, range of motion and upper extremity function in a 3-month period.

Methods: The design of this study was a comparison between 3 groups of interventions, conducted in rehabilitation clinics in Tehran. Sixty people with chronic stroke were recruited. Based on the inclusion criteria, a total of 39 stroke patients after completing the consent forms were entered to intervention groups; splint or botulinum toxin injection or combined splint/botulinum toxin injection. They were followed up about 3 months and the evaluations were done monthly. Goniometry was the method to measure range of motion, and Modified Ashworth scale was used to examine the spasticity and the upper extremity function was scored based on Fugl-Meyer assessment.   Statistical analysis was done using SPSS 17. And ANOVAs was used for comparison between groups and times.  Significance was set at 0.05.

Results: All outcome measures improved within each group but the differences between splint group and BTX-A group and the BTX-A-splint group was not significant in most outcomes during 3 periods (first evaluation until end of the first month, the end of first month until the end of second month, the end of second month until the end of the third month) (p> 0 / 05). The results also showed that the changes in elbow`s spasticity {p= 0.05} and wrist`s spasticity {p= 0.007} and upper extremity function { p = 0.04} were obvious between the three groups over the 3-months and the difference in the group of combined use of botulinum toxin and splint was more than other groups.

Conclusion: In this study, the effects of botulinum toxin injection and Volar-Dorsal Wrist/Hand Immobilization splint and the combined use of botulinum injection and splint were obvious in all groups but was not significantly different between the interventions in a 3-month follow-up.

Source: Combined Effect Of Botulinum Toxin And Splinting On Motor Components And Function Of People With Stroke | Shamili | Advances in Bioscience and Clinical Medicine

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[ARTICLE] How Can We Improve Current Practice in Spastic Paresis? – Full Text

Abstract:

Spastic paresis can arise from a variety of conditions, including stroke, spinal cord injury, multiple sclerosis, cerebral palsy, traumatic brain injury and hereditary spastic paraplegia. It is associated with muscle contracture, stiffness and pain, and can lead to segmental deformity. The positive, negative and biomechanical symptoms associated with spastic paresis can significantly affect patients’ quality of life, by affecting their ability to perform normal activities. This paper – based on the content of a global spasticity interdisciplinary masterclass presented by the authors for healthcare practitioners working in the field of spastic paresis – proposes a multidisciplinary approach to care involving not only healthcare practitioners, but also the patient and their family members/carers, and improvement of the transition between specialist care and community services. The suggested treatment pathway comprises assessment of the severity of spastic paresis, early access to neurorehabilitation and physiotherapy and treatment with botulinum toxin and new technologies, where appropriate. To address the challenge of maintaining patients’ motivation over the long term, tailored guided self-rehabilitation contracts can be used to set and monitor therapeutic goals. Current global consensus guidelines may have to be updated, to include a clinical care pathway related to the encompassing management of spastic paresis.

Spastic paresis may be caused by a variety of conditions, including stroke, spinal cord injury, multiple sclerosis, retroviral and other infectious spinal cord disorders, cerebral palsy, traumatic brain injury and hereditary spastic paraplegia.1 The exact prevalence of spastic paresis (in which spasticity is the most commonly recognised manifestation) is not known. However, it is estimated that around 30% of stroke survivors are affected by significant spasticity2 and 50% who present to hospital with stroke develop at least one severe contracture.3

Spastic paresis is a complex condition that may be associated with soft tissue contracture, pain and limitations of day-to-day activities, which have a substantial impact on patients’ and caregivers’ quality of life.4 Although treatment guidelines have been developed for (focal) spasticity,5 there remains a lack of consensus on key aspects of diagnosis, approaches to care and the care pathway that would help healthcare practitioners to more fully understand and manage this condition.

To address some of these limitations, a group of physicians and a physiotherapist with expertise in the management of spastic paresis developed a global spasticity masterclass for healthcare practitioners working in this field in order to share best practices and to discuss issues and current trends in the management of patients with spasticity. The outputs of this masterclass are presented here.

Continue —> How Can We Improve Current Practice in Spastic Paresis? | Touch Neurology | Independent Insight for Medical Specialists

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[ARTICLE] How Can We Improve Current Practice in Spastic Paresis? – Full Text HTML

Abstract:

Spastic paresis can arise from a variety of conditions, including stroke, spinal cord injury, multiple sclerosis, cerebral palsy, traumatic brain injury and hereditary spastic paraplegia. It is associated with muscle contracture, stiffness and pain, and can lead to segmental deformity. The positive, negative and biomechanical symptoms associated with spastic paresis can significantly affect patients’ quality of life, by affecting their ability to perform normal activities. This paper – based on the content of a global spasticity interdisciplinary masterclass presented by the authors for healthcare practitioners working in the field of spastic paresis – proposes a multidisciplinary approach to care involving not only healthcare practitioners, but also the patient and their family members/carers, and improvement of the transition between specialist care and community services. The suggested treatment pathway comprises assessment of the severity of spastic paresis, early access to neurorehabilitation and physiotherapy and treatment with botulinum toxin and new technologies, where appropriate. To address the challenge of maintaining patients’ motivation over the long term, tailored guided self-rehabilitation contracts can be used to set and monitor therapeutic goals. Current global consensus guidelines may have to be updated, to include a clinical care pathway related to the encompassing management of spastic paresis.

Spastic paresis may be caused by a variety of conditions, including stroke, spinal cord injury, multiple sclerosis, retroviral and other infectious spinal cord disorders, cerebral palsy, traumatic brain injury and hereditary spastic paraplegia.1 The exact prevalence of spastic paresis (in which spasticity is the most commonly recognised manifestation) is not known. However, it is estimated that around 30% of stroke survivors are affected by significant spasticity2 and 50% who present to hospital with stroke develop at least one severe contracture.3

Spastic paresis is a complex condition that may be associated with soft tissue contracture, pain and limitations of day-to-day activities, which have a substantial impact on patients’ and caregivers’ quality of life.4 Although treatment guidelines have been developed for (focal) spasticity,5 there remains a lack of consensus on key aspects of diagnosis, approaches to care and the care pathway that would help healthcare practitioners to more fully understand and manage this condition.

To address some of these limitations, a group of physicians and a physiotherapist with expertise in the management of spastic paresis developed a global spasticity masterclass for healthcare practitioners working in this field in order to share best practices and to discuss issues and current trends in the management of patients with spasticity. The outputs of this masterclass are presented here.

Pathophysiology and definitions
Spastic paresis
Spasticity is one of several components of spastic paresis, also known as the upper motor neuron (UMN) syndrome. Spastic paresis is primarily characterised by a quantitative lack of command directed to agonist muscles involved in performing movements.1,6,7 In addition, hyperactive spinal reflexes mediate some of the positive phenomena seen in spastic paresis, while other positive symptoms are related to disordered control of voluntary movement in terms of an abnormal efferent drive or are caused

Continue —> How Can We Improve Current Practice in Spastic Paresis? | Touch Neurology | Independent Insight for Medical Specialists

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[Abstract] Effect of electrical stimulation as an adjunct to botulinum toxin type A in the treatment of adult spasticity: a systematic review

Objective: To investigate whether electrical stimulation (ES) as an adjunct to BTX-A boosts botulinum activity and whether the combined therapeutic procedure is more effective than BTX-A alone in reducing spasticity in adult subjects.

Data sources: A search was conducted in PubMed, EMBASE, Cochrane Central Register, and CINAHL from January 1966 to January 2016.

Study selection: Only randomized controlled studies (RCT) involving the combination of BTX-A and ES were considered. RCTs were excluded if BTX plus ES was investigated in animals or healthy subjects; certain techniques were used as an adjunct to BTX-A, but ES was not used; BTX-A or ES were compared but were not used in combination. ES was divided into neuromuscular stimulation (NMS), functional electrical stimulation (FES), and transcutaneous electrical nerve stimulation (TENS). Two authors independently screened all search results and reviewed study characteristics using the Physiotherapy Evidence Database (PEDro) scale.

Results: Fifteen RCTs were pinpointed and nine studies were included. Trials varied in methodological quality, size, and outcome measures used. ES was used in the form of NMS and FES in seven and two studies, respectively. No study investigating BTX-A plus TENS was found. BTX-A plus ES produced significant reduction in spasticity on the Ashworth Scale (AS) and on the modified AS in seven studies, but only four showed high quality on the PEDro scale. Significant reduction in compound muscular action potential (CMAP) amplitude was detected after BTX-A plus ES in two studies.

Conclusions: ES as an adjunctive therapy to BTX-A may boost BTX-A action in reducing adult spasticity, but ES variability makes it difficult to recommend the combined therapy in clinical practice.

Implications for rehabilitation

  • Electrical stimulation (ES) as adjunct to botulinum toxin type A (BTX-A) injections may boost neurotoxin action in treating adult spasticity.

  • Given the variability of ES characteristics and the paucity of high-quality trials, it is difficult to support definitively the use of BTX-A plus ES to potentiate BTX-A effect in clinical practice.

  • A vast array of rehabilitation interventions combined with BTX-A have been provided in reducing spasticity, but the present evidence is not sufficient to recommend any combined therapeutic strategy.

Source: Effect of electrical stimulation as an adjunct to botulinum toxin type A in the treatment of adult spasticity: a systematic review: Disability and Rehabilitation: Vol 0, No 0

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[Poster] Does high-dose Botulinum Toxin has a Better Effect than Lower Dose in Spasticity Managements When given Early After Stroke

  1. To evaluate the clinical effects of treatment with a higher dose (up to 600 U) , versus a lower dose (up to 200 U) of botulinum toxin.That will be injected early after stroke, when compared with placebo, in the treatment of upper limbs spasticity after stroke.
  2. To evaluate the clinical effects of early treatment with a higher dose (up to 600 U) versus a lower dose (up to 200 U) of botulinum toxin on upper limb function recovery after stroke.
  3. To asses the effect of early Botulinum Toxin injection on pain reduction post-stroke.

Source: Does high-dose Botulinum Toxin has a Better Effect than Lower Dose in Spasticity Managements When given Early After Stroke – Archives of Physical Medicine and Rehabilitation

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[REVIEW] Mobility and the Lower Extremity | EBRSR – Evidence-Based Review of Stroke Rehabilitation – Full Text PDF

Chapter 9

Mobility and the Lower Extremity

Rehabilitation techniques of sensorimotor complications post stroke fall loosely into one of two categories; the compensatory approach or the restorative approach. While some overlap exists, the underlying philosophies of care are what set them apart. The goal of the compensatory approach towards treatment is not necessarily on improving motor recovery or reducing impairments but rather on teaching patients a new skill, even if it only involves pragmatically using the non-involved side (Gresham et al. 1995). The restorative approach focuses on traditional physical therapy exercises and neuromuscular facilitation, which involves sensorimotor stimulation, exercises and resistance training, designed to enhance motor recovery and maximize brain recovery of the neurological impairment (Gresham et al. 1995).In this review, rehabilitation of mobility and lower extremity complications is assessed. An overview of literature pertaining to the compensatory approach and the restorative approach is provided. Treatment targets discussed include balance retraining, gait retraining, strength training, cardiovascular conditioning and treatment of contractures in the lower extremities. Technologies used to aid rehabilitation include assistive devices, electrical stimulation, and splints.

For evidence tables, please click here.

Source: Mobility and the Lower Extremity | EBRSR – Evidence-Based Review of Stroke Rehabilitation

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[Abstract] Does the method of botulinum neurotoxin injection for limb spasticity affect outcomes? A systematic review.

Abstract

Objective: To systematically review randomized controlled trials of botulinum neurotoxin for limb spasticity to determine whether different injection techniques affect spasticity outcomes.

Methods: MEDLINE, EMBASE, CINAHL, and Cochrane Central Register of Controlled Trials electronic databases were searched for English language human randomized controlled trials from 1990 to 13 May 2016. Studies were assessed in duplicate for data extraction and risk of bias using the Physiotherapy Evidence Database scale and graded according to Sackett’s levels of evidence.

Results: Nine of 347 studies screened met selection criteria. Four categories of botulinum neurotoxin injection techniques were identified: (1) injection localization technique; (2) injection site selection; (3) injectate volume; (4) injection volume and site selection. There is level 1 evidence that: ultrasound, electromyography, and electrostimulation are superior to manual needle placement; endplate injections improve outcomes vs. multisite quadrant injections; motor point injections are equivalent to multisite injections; high volume injections are similar to low volume injections; and high volume injections distant from the endplate are more efficacious than low volumes closer to the endplate.

Conclusion: Level 1 evidence exists for differences in treatment outcomes using specific botulinum neurotoxin injection techniques. Findings are based on single studies that require independent replication and further study.

Source: Does the method of botulinum neurotoxin injection for limb spasticity affect outcomes? A systematic review

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[ARTICLE] Effectiveness of botulinum toxin type A on gait and quality of life in adult post-stroke patients with lower limb spasticity: a systematic review protocol – Full Text

Abstract

Review question/objective: The objective of this review is to examine the current best available evidence on the effectiveness of botulinum toxin type A on gait (velocity and distance) and quality of life (QoL) in adult post-stroke patients with lower limb spasticity.

More specifically, this review aims to determine the effectiveness of botulinum toxin type A on adult post-stroke patients with lower limb spasticity in relation to:

* Gait velocity

* Walking distance

* QoL.

Background

Stroke is a leading cause of mortality and morbidity globally. It is the third most common cause of disability globally among people over 65 years of age.1 Post-stroke spasticity is one of the important impairments following stroke along with cognitive and other sensory motor problems. Prevalence post-stroke spasticity ranges from 4% to 42.6%.2

Spasticity is one of the upper motor neuron symptoms experienced by the stroke survivors and defined as a motor disorder characterized by a velocity-dependent increase in tonic stretch reflex (muscle tone) with exaggerated tendon jerks, resulting from hyperexcitability of the stretch reflex (muscle tone) as one component of the upper motor neuron syndrome.1

Post-stroke spasticity typically affects one-half of the body, usually the upper and the lower limb, giving rise to spastic hemiparesis. Spasticity can significantly impair functions, such as mobility and activities of daily living of stroke survivors. In the lower limb, post-stroke spasticity manifests as adducted hip, stiff knee and most commonly equinovarus foot.3 Equinovarus deformity in the ankle and foot is caused by spastic or overactive gastrocnemius, soleus and/or tibialis posterior muscles. Other foot muscles, such as flexor hallucis longus and flexor digitorum longus can also be involved causing clawing of toes. The other spastic lower limb muscles, such as the quadriceps, can cause stiff knee gait,4 hamstrings knee flexion and the hip adductors (adductor magnus, brevis and longus) adduction of the hip. Spastic lower limb gives rise to the characteristic hemiplegic or circumducting gait.

Lower limb muscles are important for transferring from bed to chair, standing from a sitting position and maintaining standing balance before taking steps to walk. The deformities caused by the spastic lower limb muscles in isolation or with other impairments can potentially impede all aspects of mobility as outlined. Post-stroke spasticity can also result in spasm, pain and contracture (permanent deformity), further compounding mobility. Inability to move and lack of independence give rise to activity limitation and participation restriction, leading to poor quality of life (QoL). In some cases, spasticity associated with weakness and lack of voluntary control can lead to adverse health outcomes such as falls and fractures.5 The burden of post-stroke spasticity is high on the stroke survivor’s active function, QoL and also on the carer. Besides the human cost, there is a significant economic cost associated with post-stroke spasticity.6

Spasticity is managed by multidisciplinary rehabilitation team and by oral antispasticity medications such as baclofen, dantrolene, diazepam and clonidine and by blocking nerves with phenol or alcohol. The evidence on the efficacy of oral medications is marginal and their use is associated with adverse effects.7 Botulinum toxin type A is an important adjunctive treatment along with stretching, strengthening exercise and bracing intervention for spasticity.

Botulinum toxin (BT) is a neurotoxin and works by blocking the acetylcholine at the neuromuscular junction weakens the muscle. This is a reversible action which lasts for two to four months8, and the injection has to be repeated. There are three varieties of botulinum toxin type A – onabotulinum toxin or Botox (by Allergan), abobotulinum toxin or Dysport (Ipsen) and incobotulinum toxin or Xeomin (Merz), the first two of which are used widely. A number of studies have shown that the botulinum toxin is safe and effective in reducing focal spasticity.8,9 It has been argued that the botulinum toxin should be the first-line treatment for post-stroke spasticity.10

Botulinum toxin is expensive and the licensed indication in many countries is often restricted to the post-stroke upper limb spasticity.11 There is a number of studies demonstrating a reduction of upper limb spasticity measured by the Modified Ashworth Scale and associated disability with botulinum toxin.12 The effectiveness of the toxin in improving function is less certain – more so in the lower limbs.8 Studies have revealed strong evidence that the BT in the lower limb reduces spasticity. There have not been many randomized controlled trials (RCTs) in the lower limb showing improvement in lower limb functioning such as gait (velocity and/or distance) and improving the QoL. This may be the reason the toxin is still not approved by the pharmaceutical benefit scheme for use in the lower limb in many countries including Australia. A systematic review and meta-analysis revealed that use of BT was associated with a small but statistically significant increase in gait velocity.3 Since then, some RCTs have been carried out with BT in lower limb. From a stroke survivor’s perspective, the ability to walk remains one of the most important goals. Botulinum toxin is also useful for passive functions such as hygiene, preventing contracture and lessening the carer’s burden and in combination with physiotherapy is found to reduce the economic cost in patients with post-stroke spasticity.6 There is a recent systematic review and meta-analysis using on the efficacy of botulinum toxin type A for improving activity restriction and QoL of patients using the GRADE approach.13 This systematic review included RCTs comprising a heterogeneous group of patients with spasticity in upper or lower limb from different causes and was not specific to post stroke lower limb spasticity. Currently, no systematic review is available synthesizing evidence from RCTs focusing on the efficacy of botulinum toxin in improving gait and walking distance and QoL among post-stroke patients with lower limb spasticity.

Hence, the present systematic review aims to synthesize and evaluate the current best available evidence, drawn from RCTs, on the effectiveness of botulinum toxin type A therapy on gait velocity, walking distance and QoL, specifically in adult post-stroke patients with lower limb spasticity. The studies to be included in this review will not be restrictive of the injection technique or dosage of botulinum toxin A used to enable a comprehensive assessment of the effectiveness of the treatment. Findings from the present review will serve to inform the usefulness of botulinum toxin type A in improving the functional outcomes of patients with post-stroke lower limb spasticity over the course of rehabilitation.

Continue —> Effectiveness of botulinum toxin type A on gait and quality… : JBI Database of Systematic Reviews and Implementation Reports

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[Abstract] The efficacy of Botulinum Toxin A for limb spasticity on improving activity restriction and quality of life: a systematic review and meta-analysis using the GRADE approach.

Abstract

Objectives: A systematic review and meta analysis using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach. The aim was to evaluate the efficacy of Botulinum Toxin type A for limb spasticity on improving activity restriction and quality of life outcomes.

Data sources: Pubmed, Cinahl, Amed, Embase and Cochrane databases. English Language. Search to January 2015.

Review methods: All randomized, placebo controlled trials on adults with active function or quality of life measures for the arm and leg relating to spasticity of any origin and treated with a single dose of Botulinum Toxin A. Evidence quality was assessed by GRADE.

Results: Twenty-five studies were reviewed. Meta analysis was carried out on six upper limb and six lower limb studies. Evidence quality for the upper limb was low/very low. A significant result for Botulinum Toxin A was found at four to twelve weeks for the upper limb for active function (SMD 0.32 CI 0.01, 0.62, P=0.04) These effects were maintained for up to six months for Active Research Arm Test (ARAT) only (MD 1.87 CI 0.53, 3.21, P=0.006).

Evidence quality was very low for the lower limb. No significant effect was found. Meta analysis was not possible for quality of life measures.

Conclusion: Botulinum Toxin A may improve active outcomes in the upper limb but further evidence is needed. No conclusion can be drawn about the effect on active outcomes for the lower limb or for quality of life measures in either limb.

Source: The efficacy of Botulinum Toxin A for limb spasticity on improving activity restriction and quality of life: a systematic review and meta-analysis using the GRADE approach

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