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Botuloscope: 1-year follow-up of upper limb post-stroke spasticity treated with botulinum toxin - 02/07/19

Doi : 10.1016/j.rehab.2019.06.003 
Philippe Marque a, b, , Angelique Denis c, David Gasq a, d, Emmanuelle Chaleat-Valayer e, Alain Yelnik f, Cyrille Colin c,

Botuloscope Group1

  Djamel Bensmail, Bernard Bussel, Sophie Courtois-Jacquin, Manuella Fournier-Mehouas, Philippe Gallien, Jacques Luaute, Xavier de Boissezon, Eric Maupas, Bernard Parratte, Brigitte Perrouin-Verbe, Jacques Pelissier, Frederic Pellas, Johana Rome, Marc Rousseau, Marion Simonetta-Moreau, Christophe Vial.

Dominic Pérennou g, h
a UMR 1214–Inserm/UPS–ToNIC–Toulouse NeuroImaging Center, CHU de Purpan-Pavillon-Baudot, Place du Dr Baylac, 31024 Toulouse Cedex 3, France 
b Service de médecine physique et de réadaptation, CHU Rangueil, 1, avenue du Pr-Poulhes, 31059 Toulouse cedex 9, France 
c Département d’information médicale, hospices civil de Lyon, 162, avenue Lacassagne, 69000 Lyon, France 
d Service d’exploration fonctionnelle, CHU de Rangueil, 1, avenue du Pr-Poulhes, 31059 Toulouse cedex 9, France 
e Centre medico-chirurgical de réadaptation des Massues, 92, avenue Edmond-Locard, 69322 Lyon cedex 05, France 
f Département de médecine physique et de réadaptation, Paris Diderot University, GH Saint-Louis – Lariboisière – F. Widal, AP–HP, 200, rue Fbg St-Denis, 75010 Paris, France 
g Département de médecine physique et de réadaptation, CHU de Grenoble-Alpes–site SUD, avenue de Kimberley, 38130 Echirolles, France 
h CNRS, LPNC, University Grenoble-Alpes, 38000 Grenoble, France 

Corresponding author at:UMR 1214–Inserm/UPS–ToNIC–Toulouse NeuroImaging Center, CHU de Purpan-Pavillon-Baudot, Place du Dr Baylac, 31024 Toulouse Cedex 3, France.UMR 1214–Inserm/UPS–ToNIC–Toulouse NeuroImaging Center, CHU de Purpan-Pavillon-BaudotPlace du Dr BaylacToulouse Cedex 331024France
Sous presse. Épreuves corrigées par l'auteur. Disponible en ligne depuis le mardi 02 juillet 2019
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Highlights

First large cohort study independant of the pharmaceutical industry.
Quality of life is improved by treating upper limb spasticity with botulinum toxin type A (BoNT-A), even 5 years post-stroke.
Personalized objectives of treatment magnified the efficacy.
BoNT-A is an efficient treatment for reducing pain related to spasticity.
Adverse effects concerned 19% of patients.

Le texte complet de cet article est disponible en PDF.

Abstract

Background

Botuloscope is a cohort study supported by a French public grant and aiming to evaluate a 1-year treatment of the post-stroke spastic upper limb with botulinum toxin type A (BoNT-A) in terms of individual satisfaction with respect to personalized goals and quality of life.

Methods

This was an open-label prospective, multicentric study (11 French centres) that followed 330 adults [mean (SD) age 53.7 (13.7) years] over 1 year; participants had ranked 5 therapeutic goals at inclusion [mean (SD) 5.1 (7.3) years post-stroke], had severe hemiparesis [median motricity index (MI) 40 (Q1–Q3 24 to 60)], and were assessed at inclusion (M0) and at month 3 (M3) and M12. Outcome criteria were: spasticity, range of motion, pain [visual analog scale (VAS)], motor function [Modified Ashworth Scale (MAS)] and activities (MI; Frenchay Arm Test), and overall satisfaction with the achievement of each goal (VAS) and quality of life (Reintegration to Normal Life Index). Criteria at M0 and M12 were compared. Adverse effects were also collected, as were medication changes.

Results

The primary goal was comfort and activities for 63% of participants and motor function for 36%. Participants underwent a mean of 2.4 injection sessions, 19% causing adverse effects. The greatest spasticity attenuation occurred with wrist flexors (median decrease in MAS −2 [Q1–Q3; −2 to −1], P<10−3). Fewer individuals took oral anti-spastic drugs (56% at M12 vs 50% at M0; P<10−2). Range of motion increased by 16°, on average (13 to 19; P<10−3) for wrist extension. Pain prevalence decreases at rest (29% at M0 vs. 19% at M12; P<10−4) and during mobilization (64% vs. 43%; P<10−4), and fewer participants took analgesics (25% vs. 17%; P<10−3). Satisfaction was high for the goals “hand hygiene” and “pain release” and moderate for “improvement in upper limb function”. However, function was more improved for participants who selected this goal as the first priority than others (P<10−2). Overall, 22% had the goal “improving gait and balance”, which was reasonably achieved at M12. Quality of life improved markedly [median 8 (4 to 11) vs. 6 (3 to 10); P<10−4]. Prevalence of complete dissatisfaction with the first objective was 10% to 15%.

Conclusion

This is the first long-term follow-up of BoNT-A treatment for upper limb spasticity involving a large cohort independent of industry. Quality of life was improved by treating upper limb spasticity with BoNT-A, even at 5 years post-stroke. Personalizing objectives of the treatment amplified its efficacy. BoNT-A was a powerful analgesic when pain was spasticity-related. Treating the spastic upper limb also improved balance and gait abilities.

Le texte complet de cet article est disponible en PDF.

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