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AbobotulinumtoxinA: A New Therapy for Hip Osteoarthritis. A Prospective Randomized Double-Blind Multicenter Study

Hip Osteoarthritis (OA) causes pain and disability. Here we evaluate abobotulinumtoxinA (Dysport(®)) (AboBoNT-A) injections versus placebo as a novel treatment option to improve hip range of motion, pain and quality of life. This prospective randomized double-blind multicenter study (EudraCT # 2012-...

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Autores principales: Eleopra, Roberto, Rinaldo, Sara, Lettieri, Christian, Santamato, Andrea, Bortolotti, Paolo, Lentino, Carmelo, Tamborino, Carmine, Causero, Araldo, Devigili, Grazia
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6266300/
https://www.ncbi.nlm.nih.gov/pubmed/30384438
http://dx.doi.org/10.3390/toxins10110448
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author Eleopra, Roberto
Rinaldo, Sara
Lettieri, Christian
Santamato, Andrea
Bortolotti, Paolo
Lentino, Carmelo
Tamborino, Carmine
Causero, Araldo
Devigili, Grazia
author_facet Eleopra, Roberto
Rinaldo, Sara
Lettieri, Christian
Santamato, Andrea
Bortolotti, Paolo
Lentino, Carmelo
Tamborino, Carmine
Causero, Araldo
Devigili, Grazia
author_sort Eleopra, Roberto
collection PubMed
description Hip Osteoarthritis (OA) causes pain and disability. Here we evaluate abobotulinumtoxinA (Dysport(®)) (AboBoNT-A) injections versus placebo as a novel treatment option to improve hip range of motion, pain and quality of life. This prospective randomized double-blind multicenter study (EudraCT # 2012-004890-25) recruited 46 outpatients with hip OA who were randomized 2:1 to the Treatment Group (TG; 31 subjects), or the Placebo Group (PG; 15 subjects). The TG received 400 U of AboBoNT-A injected into the adductor muscles, and the PG received placebo solution. The primary endpoints were the difference in Harris Hip Score (HHS) and Visual Analogic Scale for pain (VAS) at Week 4 between groups (TG vs. PG). Secondary endpoints were the change from baseline in HHS, VAS pain, Medical Research Council scale for muscle strength (MRC) and Short Form scale (SF-36) scores. In TG at Week 4, the HHS and VAS score were significantly improved compared to PG, and pairwise assessments showed significant improvements in HSS and VAS pain at each time point compared to baseline for TG. No significant changes were observed in MRC and SF-36 over time, though SF-36 showed a positive trend. There were no significant differences from baseline in the PG. No adverse events were detected in either treatment group. AboBoNT-A injections in hip OA improve range of motion and pain without any significant side effects.
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spelling pubmed-62663002018-12-07 AbobotulinumtoxinA: A New Therapy for Hip Osteoarthritis. A Prospective Randomized Double-Blind Multicenter Study Eleopra, Roberto Rinaldo, Sara Lettieri, Christian Santamato, Andrea Bortolotti, Paolo Lentino, Carmelo Tamborino, Carmine Causero, Araldo Devigili, Grazia Toxins (Basel) Article Hip Osteoarthritis (OA) causes pain and disability. Here we evaluate abobotulinumtoxinA (Dysport(®)) (AboBoNT-A) injections versus placebo as a novel treatment option to improve hip range of motion, pain and quality of life. This prospective randomized double-blind multicenter study (EudraCT # 2012-004890-25) recruited 46 outpatients with hip OA who were randomized 2:1 to the Treatment Group (TG; 31 subjects), or the Placebo Group (PG; 15 subjects). The TG received 400 U of AboBoNT-A injected into the adductor muscles, and the PG received placebo solution. The primary endpoints were the difference in Harris Hip Score (HHS) and Visual Analogic Scale for pain (VAS) at Week 4 between groups (TG vs. PG). Secondary endpoints were the change from baseline in HHS, VAS pain, Medical Research Council scale for muscle strength (MRC) and Short Form scale (SF-36) scores. In TG at Week 4, the HHS and VAS score were significantly improved compared to PG, and pairwise assessments showed significant improvements in HSS and VAS pain at each time point compared to baseline for TG. No significant changes were observed in MRC and SF-36 over time, though SF-36 showed a positive trend. There were no significant differences from baseline in the PG. No adverse events were detected in either treatment group. AboBoNT-A injections in hip OA improve range of motion and pain without any significant side effects. MDPI 2018-10-31 /pmc/articles/PMC6266300/ /pubmed/30384438 http://dx.doi.org/10.3390/toxins10110448 Text en © 2018 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Eleopra, Roberto
Rinaldo, Sara
Lettieri, Christian
Santamato, Andrea
Bortolotti, Paolo
Lentino, Carmelo
Tamborino, Carmine
Causero, Araldo
Devigili, Grazia
AbobotulinumtoxinA: A New Therapy for Hip Osteoarthritis. A Prospective Randomized Double-Blind Multicenter Study
title AbobotulinumtoxinA: A New Therapy for Hip Osteoarthritis. A Prospective Randomized Double-Blind Multicenter Study
title_full AbobotulinumtoxinA: A New Therapy for Hip Osteoarthritis. A Prospective Randomized Double-Blind Multicenter Study
title_fullStr AbobotulinumtoxinA: A New Therapy for Hip Osteoarthritis. A Prospective Randomized Double-Blind Multicenter Study
title_full_unstemmed AbobotulinumtoxinA: A New Therapy for Hip Osteoarthritis. A Prospective Randomized Double-Blind Multicenter Study
title_short AbobotulinumtoxinA: A New Therapy for Hip Osteoarthritis. A Prospective Randomized Double-Blind Multicenter Study
title_sort abobotulinumtoxina: a new therapy for hip osteoarthritis. a prospective randomized double-blind multicenter study
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6266300/
https://www.ncbi.nlm.nih.gov/pubmed/30384438
http://dx.doi.org/10.3390/toxins10110448
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