Título

Comparative study of the mechanism of action of Dry Needling and Botulinum Toxin type A as a treatment for lower limb post-stroke spasticity: a proof of concept controlled trial

Estudio comparativo del mecanismo de acción de la Punción Seca y la Toxina Botulínica tipo A como tratamiento de la espasticidad post-ictus de miembros inferiores: ensayo controlado de prueba de concepto.


Descripción

Stroke is a leading cause of disease, disability, and economic loss. As populations grow and people live longer, cases of stroke are likely to increase. Stroke affects the central nervous system and interferes with mobility and walking.

One consequence of stroke is muscle spasticity (stiffness) that affects half of stroke victims within six months, causing discomfort and hindering recovery. One of the most effective treatments for spasticity is the injection of Botulinum Toxin type A (BTX-A), which is considered ‘invasive’ and has been linked to several side effects.

'Dry needling' (DN) is a relatively new treatment for spasticity with comparable effectiveness as BTX-A. DN is minimally invasive and has fewer side effects. However, it is not usually applied in current clinical practice. While studies have reported the effects of these two techniques on muscle and mobility, the effects on the whole system have not been systematically studied.


Objetivos y Resultados

We hypothesize that DN and BTX-A will have similar effects on decreasing spasticity, but DN will have fewer side effects and will be more acceptable to patients and their families. We will study this by examining the effects of each treatment on ankle muscles in two groups of subjects. One group will receive a series of 12 DN sessions and the other will have one BTX-A injection. We will evaluate effects on spasticity at different levels – muscle structure, reflex activity, motor ability, quality of life, acceptability, and cost-effectiveness. We will use novel methods to help clinicians, patients, and families make more informed spasticity treatment choices.


IP IIS Aragón

Dr. Pablo Herrero


Organismo Financiador

Subvención económica concedida dentro de la Convocatoria Proyecto de Colaboración Internacional de la AES-2022 y ligado a la Acción Conjunta Internacional ERA Net Neuron.

Financiado por el Instituto de Salud Carlos III con cargo a los fondos europeos del Plan de Recuperación, Transformación y Resiliencia, con código de expediente AC22/00016, en virtud de Resolución de la Dirección del Instituto de Salud Carlos III, O.A., M.P. DE 15 de diciembre de 2022, por la que se conceden subvenciones para Proyectos de colaboración internacional de la convocatoria 2022 de la Acción Estratégica en Salud 2021-2023, con cargo a los fondos europeos del Plan de Recuperación, Transformación y Resiliencia y “Financiado por la Unión Europea – Next-Generation EU.

Presupuesto total del Proyecto: 755.249 €

Financiación ISCIII: 239.882,5 €


Coordinador

Fundación Instituto de Investigación Sanitaria Aragón (IIS Aragón), España


Socios

- McGill University (MGU), Montreal (Canada)
- University of Antwerp (ANT), Antwerp (Belgium).


Duración

01/01/2023 – 31/12/2025 (36 meses)


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