[ARTICLE] Patient Registry of Spasticity Care World: Data Analysis Based on Physician Experience – Full Text

Objective The aim of the study was to report physician experience–based “real-world” treatment patterns with botulinum toxin type A in patients with stroke and traumatic brain injury.

Design A prospective, multicenter, international observational registry design was used.

Results Six hundred twenty-seven participants with stroke and 132 participants with traumatic brain injury were assessed and treated by 17 more experienced physicians and 12 less experienced physicians. Due to the limited usage of abobotulinumtoxinA Dysport and incobotulinumtoxinA Xeomin, data were reported on onabotulinumtoxinA BOTOX only. Based on physician experience, onabotulinumtoxinA doses were statistically different with larger mean doses injected by more experienced physicians in the upper limb (59.9 [39.0], P = 0.001) and in the lower limb (101.8 [69.2], P < 0.001). Treated deformities significantly differed for both upper limb and lower limb (P < 0.001). More experienced physicians showed a larger mean change in Ashworth Scale scores from baseline for the equinovarus/equinus foot and stiff knee (P = 0.001 and 0.03). Less experienced physicians showed a larger mean change in Ashworth Scale scores from baseline for the adducted thigh (P = 0.05). Less experienced physicians had statistically significant larger change in hand pain scores for clenched fist deformity treatment at follow-up compared with more experienced physicians (P = 0.01). Physician experience demonstrated a significant difference on patients reported satisfaction toward their secondary goal with higher scores for more experienced physician (P = 0.04).

Conclusions This international registry provides clinical nuances of treatment based on physician clinical experience in a robust sample size.

 

Every year, 15 million people worldwide are adversely affected by a stroke, and according to the World Health Organization, traumatic brain injury (TBI) will surpass by 2020 many other diseases as the major cause of death and disability.¹ Functional problems caused by stroke or a TBI may include paralysis, cognitive and speech changes, and impaired motor control and dexterity as well as abnormal muscle activity that include spasticity, clonus, dystonia, co-contraction, associated reactions, and flexor and extensor spasms as seen in the upper motor neuron syndrome.²Spasticity as a motor behavior is a specific physiologic sign that has classically been described by Lance et al.³ as one component of the upper motor neuron syndrome, distinguishable from other positive features of muscle overactivity (e.g., dystonia, co-contraction). For simplification, all of these abnormal muscle activation patterns are frequently referred to as “spasticity.”⁴ We have elected the term spastic muscle overactivity as a more encompassing and better suited term.^5–7Muscle overactivity can result in multiple patterns of clinical motor dysfunction affecting the lower (e.g., equinovarus, stiff knee, striatal toe, adducted thighs, flexed hip) and/or upper limbs (flexed elbow, internally rotated shoulder, flexed wrist, clenched fist, thumb-in-palm, intrinsics).⁴

Botulinum toxin has become a widely used biological toxin for a growing number of clinical applications. Clinical trials provide evidence that botulinum toxin can improve symptoms of muscle overactivity when appropriate muscles, doses, and the number of injection sites are selected.^4,7 The proper use of these treatments in a “real-world” setting is not restricted to a regimented dosing structure provided by a clinical trial requires appropriate training and education. As in other areas of medicine, physician experience may play a role in care delivery. Physician level of experience may serve as a surrogate in understanding physician practice patterns variation that can inform healthcare services use⁸ and reduce physician care variations.⁹ Given these information void, we proposed and conducted a global, multicenter, observational study of participants treated with botulinum toxins in patients with stroke- or TBI-related spastic muscle overactivity to generate real-world data. The use of botulinum toxin A varies internationally; onabotulinumtoxinA (onaBoNTA) BOTOX has been approved for use in the United States for many years, whereas abobotulinumtoxinA (aboBoNTA) Dysport and incobotulinumtoxinA (incoBoNTA) Xeomin were only recently approved (2016). The onaBoNTA and aboBoNTA have been in use in Europe for more than 20 yrs, and incoBoNTA was approved only 10 yrs ago. Published registries have presented real-life data on the treatment of spasticity with onaBonTA^10–12; however, to our knowledge, this is the first international registry that includes real-world longitudinal data that include baseline, injection, and outcomes when using the various botulinum toxins available while considering physician experience for its stratification and analysis. Despite the available evidence of botulinum toxin use, it is unclear whether physician level of experience may play a role in the appropriate delivery of toxin-related care. We hypothesized that the physician experience level may impart differences in care patterns in the use of botulinum toxin for spasticity management. Specifically, we focus on analyses based on the physician experience related to the identification of the problem presentation, muscle selection for treatment, formulation selected, dosing, injection technique, dilution, and number of injection sites. We also recorded the primary and secondary goals for treatment as selected by the patient and agreed upon by the treating physician. The primary purpose for this registry was to describe treatment patterns and clinical presentation used in these populations from a global perspective on the basis of clinical experience. Ashworth Scale (AS), presence of pain, and patient-reported satisfaction after treatment were stratified on the basis of reported physicians’ clinical experiences to determine treatment effect.[…]

Continue —> Patient Registry of Spasticity Care World: Data Analysis Bas… : American Journal of Physical Medicine & Rehabilitation

[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