Clinical efficacy of botulinum toxin type A in patients with traumatic brain injury, spinal cord injury, or multiple sclerosis: An observational longitudinal study
Botulinum toxin type A (BoNT-A) is the treatment of choice for focal spasticity, with a concomitant effect on pain reduction and improvement of quality of life (QoL). Current evidence of its efficacy is based mainly on post stroke spasticity. This study aims to clarify the role of BoNT-A in the cont...
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Published in | Frontiers in neurology Vol. 14; p. 1133390 |
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Main Authors | , , , , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
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06.04.2023
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Abstract | Botulinum toxin type A (BoNT-A) is the treatment of choice for focal spasticity, with a concomitant effect on pain reduction and improvement of quality of life (QoL). Current evidence of its efficacy is based mainly on post stroke spasticity. This study aims to clarify the role of BoNT-A in the context of non-stroke spasticity (NSS). We enrolled 86 patients affected by multiple sclerosis, spinal cord injury, and traumatic brain injury with clinical indication to perform BoNT-A treatment. Subjects were evaluated before injection and after 1, 3, and 6 months. At every visit, spasticity severity using the modified Ashworth scale, pain using the numeric rating scale, QoL using the Euro Qol Group EQ-5D-5L, and the perceived treatment effect using the Global Assessment of Efficacy scale were recorded. In our population BoNT-A demonstrated to have a significant effect in improving all the outcome variables, with different effect persistence over time in relation to the diagnosis and the number of treated sites. Our results support BoNT-A as a modifier of the disability condition and suggest its implementation in the treatment of NSS, delivering a possible starting point to generate diagnosis-specific follow-up programs.
NCT04673240. |
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AbstractList | Botulinum toxin type A (BoNT-A) is the treatment of choice for focal spasticity, with a concomitant effect on pain reduction and improvement of quality of life (QoL). Current evidence of its efficacy is based mainly on post stroke spasticity. This study aims to clarify the role of BoNT-A in the context of non-stroke spasticity (NSS). We enrolled 86 patients affected by multiple sclerosis, spinal cord injury, and traumatic brain injury with clinical indication to perform BoNT-A treatment. Subjects were evaluated before injection and after 1, 3, and 6 months. At every visit, spasticity severity using the modified Ashworth scale, pain using the numeric rating scale, QoL using the Euro Qol Group EQ-5D-5L, and the perceived treatment effect using the Global Assessment of Efficacy scale were recorded. In our population BoNT-A demonstrated to have a significant effect in improving all the outcome variables, with different effect persistence over time in relation to the diagnosis and the number of treated sites. Our results support BoNT-A as a modifier of the disability condition and suggest its implementation in the treatment of NSS, delivering a possible starting point to generate diagnosis-specific follow-up programs. Botulinum toxin type A (BoNT-A) is the treatment of choice for focal spasticity, with a concomitant effect on pain reduction and improvement of quality of life (QoL). Current evidence of its efficacy is based mainly on post stroke spasticity. This study aims to clarify the role of BoNT-A in the context of non-stroke spasticity (NSS). We enrolled 86 patients affected by multiple sclerosis, spinal cord injury, and traumatic brain injury with clinical indication to perform BoNT-A treatment. Subjects were evaluated before injection and after 1, 3, and 6 months. At every visit, spasticity severity using the modified Ashworth scale, pain using the numeric rating scale, QoL using the Euro Qol Group EQ-5D-5L, and the perceived treatment effect using the Global Assessment of Efficacy scale were recorded. In our population BoNT-A demonstrated to have a significant effect in improving all the outcome variables, with different effect persistence over time in relation to the diagnosis and the number of treated sites. Our results support BoNT-A as a modifier of the disability condition and suggest its implementation in the treatment of NSS, delivering a possible starting point to generate diagnosis-specific follow-up programs. NCT04673240. Botulinum toxin type A (BoNT-A) is the treatment of choice for focal spasticity, with a concomitant effect on pain reduction and improvement of quality of life (QoL). Current evidence of its efficacy is based mainly on post stroke spasticity. This study aims to clarify the role of BoNT-A in the context of non-stroke spasticity (NSS). We enrolled 86 patients affected by multiple sclerosis, spinal cord injury, and traumatic brain injury with clinical indication to perform BoNT-A treatment. Subjects were evaluated before injection and after 1, 3, and 6 months. At every visit, spasticity severity using the modified Ashworth scale, pain using the numeric rating scale, QoL using the Euro Qol Group EQ-5D-5L, and the perceived treatment effect using the Global Assessment of Efficacy scale were recorded. In our population BoNT-A demonstrated to have a significant effect in improving all the outcome variables, with different effect persistence over time in relation to the diagnosis and the number of treated sites. Our results support BoNT-A as a modifier of the disability condition and suggest its implementation in the treatment of NSS, delivering a possible starting point to generate diagnosis-specific follow-up programs. Clinical trial identifier NCT04673240. Botulinum toxin type A (BoNT-A) is the treatment of choice for focal spasticity, with a concomitant effect on pain reduction and improvement of quality of life (QoL). Current evidence of its efficacy is based mainly on post stroke spasticity. This study aims to clarify the role of BoNT-A in the context of non-stroke spasticity (NSS). We enrolled 86 patients affected by multiple sclerosis, spinal cord injury, and traumatic brain injury with clinical indication to perform BoNT-A treatment. Subjects were evaluated before injection and after 1, 3, and 6 months. At every visit, spasticity severity using the modified Ashworth scale, pain using the numeric rating scale, QoL using the Euro Qol Group EQ-5D-5L, and the perceived treatment effect using the Global Assessment of Efficacy scale were recorded. In our population BoNT-A demonstrated to have a significant effect in improving all the outcome variables, with different effect persistence over time in relation to the diagnosis and the number of treated sites. Our results support BoNT-A as a modifier of the disability condition and suggest its implementation in the treatment of NSS, delivering a possible starting point to generate diagnosis-specific follow-up programs.Clinical trial identifierNCT04673240. |
Author | Millevolte, Marzia Santamato, Andrea Picelli, Alessandro Chisari, Carmelo Invernizzi, Marco Cinone, Nicoletta Baricich, Alessio Battaglia, Marco Cosenza, Lucia Azzollini, Valentina Spina, Stefania Filippetti, Mirko Dalise, Stefania Scotti, Lorenza Paolucci, Stefano Cosma, Michela Cuneo, Daria |
AuthorAffiliation | 1 Physical and Rehabilitation Medicine, Department of Health Sciences, Università del Piemonte Orientale , Novara , Italy 7 Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona , Verona , Italy 6 Neuroscience and Rehabilitation Department, Ferrara University Hospital , Ferrara , Italy 4 Rehabilitation Unit, Department of Rehabilitation, “Santi Antonio e Biagio e Cesare Arrigo” National Hospital , Alessandria , Italy 10 Department of Translational Medicine, Unit of Medical Statistics, Università del Piemonte Orientale , Novara , Italy 5 Neurorehabilitation Clinic, Department Neurological Sciences, University Hospital of Ancona , Ancona , Italy 8 Neurorehabilitation Section, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa , Pisa , Italy 11 Dipartimento Attività Integrate Ricerca e Innovazione (DAIRI), Translational Medicine, “Santi Antonio e Biagio e Cesare Arrigo” National Hospital , Alessandria , Italy 2 Phys |
AuthorAffiliation_xml | – name: 10 Department of Translational Medicine, Unit of Medical Statistics, Università del Piemonte Orientale , Novara , Italy – name: 7 Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona , Verona , Italy – name: 6 Neuroscience and Rehabilitation Department, Ferrara University Hospital , Ferrara , Italy – name: 8 Neurorehabilitation Section, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa , Pisa , Italy – name: 5 Neurorehabilitation Clinic, Department Neurological Sciences, University Hospital of Ancona , Ancona , Italy – name: 12 IRCCS Fondazione Santa Lucia , Rome , Italy – name: 2 Physical and Rehabilitation Medicine, “Ospedale Maggiore della Carità” University Hospital , Novara , Italy – name: 9 Spasticity and Movement Disorder Unit, Physical Medicine and Rehabilitation, Policlinico Riuniti, University of Foggia , Foggia , Italy – name: 11 Dipartimento Attività Integrate Ricerca e Innovazione (DAIRI), Translational Medicine, “Santi Antonio e Biagio e Cesare Arrigo” National Hospital , Alessandria , Italy – name: 3 Physical and Rehabilitation Medicine, A.S.L. Vercelli , Vercelli , Italy – name: 1 Physical and Rehabilitation Medicine, Department of Health Sciences, Università del Piemonte Orientale , Novara , Italy – name: 4 Rehabilitation Unit, Department of Rehabilitation, “Santi Antonio e Biagio e Cesare Arrigo” National Hospital , Alessandria , Italy |
Author_xml | – sequence: 1 givenname: Alessio surname: Baricich fullname: Baricich, Alessio organization: Physical and Rehabilitation Medicine, "Ospedale Maggiore della Carità" University Hospital, Novara, Italy – sequence: 2 givenname: Marco surname: Battaglia fullname: Battaglia, Marco organization: Physical and Rehabilitation Medicine, "Ospedale Maggiore della Carità" University Hospital, Novara, Italy – sequence: 3 givenname: Daria surname: Cuneo fullname: Cuneo, Daria organization: Physical and Rehabilitation Medicine, A.S.L. Vercelli, Vercelli, Italy – sequence: 4 givenname: Lucia surname: Cosenza fullname: Cosenza, Lucia organization: Rehabilitation Unit, Department of Rehabilitation, "Santi Antonio e Biagio e Cesare Arrigo" National Hospital, Alessandria, Italy – sequence: 5 givenname: Marzia surname: Millevolte fullname: Millevolte, Marzia organization: Neurorehabilitation Clinic, Department Neurological Sciences, University Hospital of Ancona, Ancona, Italy – sequence: 6 givenname: Michela surname: Cosma fullname: Cosma, Michela organization: Neuroscience and Rehabilitation Department, Ferrara University Hospital, Ferrara, Italy – sequence: 7 givenname: Mirko surname: Filippetti fullname: Filippetti, Mirko organization: Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy – sequence: 8 givenname: Stefania surname: Dalise fullname: Dalise, Stefania organization: Neurorehabilitation Section, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy – sequence: 9 givenname: Valentina surname: Azzollini fullname: Azzollini, Valentina organization: Neurorehabilitation Section, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy – sequence: 10 givenname: Carmelo surname: Chisari fullname: Chisari, Carmelo organization: Neurorehabilitation Section, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy – sequence: 11 givenname: Stefania surname: Spina fullname: Spina, Stefania organization: Spasticity and Movement Disorder Unit, Physical Medicine and Rehabilitation, Policlinico Riuniti, University of Foggia, Foggia, Italy – sequence: 12 givenname: Nicoletta surname: Cinone fullname: Cinone, Nicoletta organization: Spasticity and Movement Disorder Unit, Physical Medicine and Rehabilitation, Policlinico Riuniti, University of Foggia, Foggia, Italy – sequence: 13 givenname: Lorenza surname: Scotti fullname: Scotti, Lorenza organization: Department of Translational Medicine, Unit of Medical Statistics, Università del Piemonte Orientale, Novara, Italy – sequence: 14 givenname: Marco surname: Invernizzi fullname: Invernizzi, Marco organization: Dipartimento Attività Integrate Ricerca e Innovazione (DAIRI), Translational Medicine, "Santi Antonio e Biagio e Cesare Arrigo" National Hospital, Alessandria, Italy – sequence: 15 givenname: Stefano surname: Paolucci fullname: Paolucci, Stefano organization: IRCCS Fondazione Santa Lucia, Rome, Italy – sequence: 16 givenname: Alessandro surname: Picelli fullname: Picelli, Alessandro organization: Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy – sequence: 17 givenname: Andrea surname: Santamato fullname: Santamato, Andrea organization: Spasticity and Movement Disorder Unit, Physical Medicine and Rehabilitation, Policlinico Riuniti, University of Foggia, Foggia, Italy |
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CitedBy_id | crossref_primary_10_1016_j_toxicon_2024_107363 crossref_primary_10_3390_toxins16070309 crossref_primary_10_3390_medicina60010023 crossref_primary_10_3390_toxins16040184 |
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Copyright | Copyright © 2023 Baricich, Battaglia, Cuneo, Cosenza, Millevolte, Cosma, Filippetti, Dalise, Azzollini, Chisari, Spina, Cinone, Scotti, Invernizzi, Paolucci, Picelli and Santamato. Copyright © 2023 Baricich, Battaglia, Cuneo, Cosenza, Millevolte, Cosma, Filippetti, Dalise, Azzollini, Chisari, Spina, Cinone, Scotti, Invernizzi, Paolucci, Picelli and Santamato. 2023 Baricich, Battaglia, Cuneo, Cosenza, Millevolte, Cosma, Filippetti, Dalise, Azzollini, Chisari, Spina, Cinone, Scotti, Invernizzi, Paolucci, Picelli and Santamato |
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Keywords | botulinum toxin spinal cord injury pain rehabilitation multiple sclerosis traumatic brain injury spasticity movement disorders |
Language | English |
License | Copyright © 2023 Baricich, Battaglia, Cuneo, Cosenza, Millevolte, Cosma, Filippetti, Dalise, Azzollini, Chisari, Spina, Cinone, Scotti, Invernizzi, Paolucci, Picelli and Santamato. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
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Notes | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 Reviewed by: Laura Mori, University of Genoa, Italy; Philippe Picaut, Algo Therapeutix, France This article was submitted to Neurorehabilitation, a section of the journal Frontiers in Neurology Edited by: Luigi Tesio, University of Milan, Italy |
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SubjectTerms | botulinum toxin movement disorders multiple sclerosis Neurology pain spasticity spinal cord injury |
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Title | Clinical efficacy of botulinum toxin type A in patients with traumatic brain injury, spinal cord injury, or multiple sclerosis: An observational longitudinal study |
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