RESUMEN
INTRODUCTION: Spasticity is common after a stroke and is an independent risk factor for developing pain. BotulinumtoxinA injection is the treatment of choice for focal spasticity. We examined the effect of intramuscular botulinumtoxinA on pain relief in patients in routine clinical practice who were experiencing pain as a primary complaint associated with post-stroke lower limb spasticity. METHODS: Prospective, multicentre, post-marketing observational study. The study period was 16 months. The primary effectiveness variable was the mean change from baseline on the pain 0-10 Numerical Rating Scale after four botulinumtoxinA injection cycles. Secondary endpoints included changes from baseline on the pain 0-100 Visual Analogue Scale, Goal Attainment Scale, modified Ashworth Scale, 10-Meter Walk Test, Penn Spasm Frequency Scale, and 36-item Short-Form Health Survey. RESULTS: Of 186 enrolled patients, 180 (96.8%) received botulinumtoxinA at least once. The mean (standard deviation) pain 0-10 Numerical Rating Scale score decreased significantly (p<0.0001) from 4.9 (2.2) at baseline to 2.5 (2.1) at study end, representing a 50% decrease in pain severity. Relief of pain due to spasticity was supported by improvement from baseline in all secondary variables except the 10-Meter Walk Test. Two adverse events (erysipelas and phlebitis) in one patient were considered likely to be related to botulinumtoxinA injection. CONCLUSION: BotulinumtoxinA appears to provide pain relief as an additional benefit of local treatment in patients with post-stroke lower limb spasticity for whom pain relief is a primary therapeutic goal (a Lay Abstract has been provided as Appendix A).
Asunto(s)
Toxinas Botulínicas Tipo A , Extremidad Inferior , Espasticidad Muscular , Fármacos Neuromusculares , Dimensión del Dolor , Accidente Cerebrovascular , Humanos , Espasticidad Muscular/tratamiento farmacológico , Espasticidad Muscular/etiología , Estudios Prospectivos , Femenino , Masculino , Toxinas Botulínicas Tipo A/administración & dosificación , Accidente Cerebrovascular/complicaciones , Persona de Mediana Edad , Anciano , Fármacos Neuromusculares/administración & dosificación , Inyecciones Intramusculares , Dolor/etiología , Dolor/tratamiento farmacológico , Manejo del Dolor/métodos , Vigilancia de Productos Comercializados , Resultado del TratamientoRESUMEN
La espasticidad es un fenómeno complejo de expresión clínica extremadamente variable, un proceso dinámico y evolutivo que puede condicionar la funcionalidad y tratamiento del paciente. La recomendación actual de tratamiento temprano persigue evitar su progresión y complicaciones, e implica un planteamiento individualizado basado en un amplio abanico de medidas farmacológicas y no farmacológicas. Esta guía resulta de un foro de especialistas expertos que afrontaron algunas incertezas frecuentes en el proceso de valoración y planteamiento terapéutico como la idoneidad de iniciar tratamiento, consideraciones para iniciar, continuar y cesar el tratamiento con toxina botulínica, tratamientos adyuvantes, el dolor o el seguimiento del paciente espástico. El resultado es un algoritmo de decisión para el abordaje terapéutico de la espasticidad. Tanto el avance científico como el intercambio de experiencia clínica en el que se basa esta guía puede apoyar la toma de decisiones sobre algunas áreas de penumbra que encontramos en la práctica clínica diaria.(AU)
Spasticity is a complex phenomenon of extremely variable clinical expression, a dynamic and evolutionary process that can condition the activity and treatment of the patient. The current recommendation for early treatment aims to avoid progression and complications, and involves an individualized approach based on a wide range of pharmacological and non-pharmacological measures. This guide results from a forum of expert specialists who faced some frequent uncertainties in the assessment process and therapeutic approach of the spastic patient such as the suitability of initiating treatment, considerations for initiating, continuing and ceasing treatment with botulinum toxin, adjuvant treatments, pain or follow-up. The result is one algorithm of decision for the therapeutic approach of spasticity. Both scientific progress and the exchange of clinical experience on which this guide is based, can support decision-making on some areas of gloom that we find in daily practice.(AU)
Asunto(s)
Espasticidad Muscular , Toxinas Botulínicas Tipo A , Terapéutica , Algoritmos , Dolor , Manejo del Dolor , Ondas de Radio , Bloqueo Nervioso , Medicina Física y RehabilitaciónRESUMEN
Spasticity is a complex phenomenon of extremely variable clinical expression, a dynamic and evolutionary process that can condition the activity and treatment of the patient. The current recommendation for early treatment aims to avoid progression and complications, and involves an individualized approach based on a wide range of pharmacological and non-pharmacological measures. This guide results from a forum of expert specialists who faced some frequent uncertainties in the assessment process and therapeutic approach of the spastic patient such as the suitability of initiating treatment, considerations for initiating, continuing and ceasing treatment with botulinum toxin, adjuvant treatments, pain or follow-up. The result is one algorithm of decision for the therapeutic approach of spasticity. Both scientific progress and the exchange of clinical experience on which this guide is based, can support decision-making on some areas of gloom that we find in daily practice.