| Titre : | Botulinum Toxin Type B in the Spastic Arm: A Randomized, Double-Blind, Placebo-Controlled, Preliminary Study (2014) |
| Auteurs : | Jean-Michel Gracies ; Nicolas Bayle ; Sarah Goldberg |
| Type de document : | Article |
| Dans : | Archives of Physical Medicine and Rehabilitation (2014/7, 2014) |
| Article en page(s) : | p. 1303-1311 |
| Langues: | Anglais |
| Descripteurs : |
HE Vinci Accident vasculaire cérébral (AVC) ; Rééducation et réadaptation |
| Mots-clés: | Botulinum Toxins ; Toxines botuliniques ; Randomized Controlled Trials as Topic ; Essais contrôlés randomisés comme sujet ; Stroke |
| Résumé : |
Objective To determine the efficacy and safety of 2 doses of botulinum toxin type B (rimabotulinumtoxinB, BoNT/B) in spastic upper limb muscles. Design Randomized, double-blind, placebo-controlled trial with a 3-month follow-up. Setting Tertiary care center. Participants Referred sample of adult hemiparetic patients (N=24) with disabling elbow flexor overactivity after stroke or traumatic brain injury. Interventions Injection of 10,000U of rimabotulinumtoxinB (fixed 2500U dose into elbow flexors; n=8), 15,000U (5000U into elbow flexors; n=8), or placebo (n=8) into overactive upper limb muscles selected as per investigator's discretion. Main Outcome Measures At 1 month postinjection, active range of elbow extension (goniometry; primary outcome); active upper limb function (Modified Frenchay Scale [MFS]); subjective global self-assessment (GSA) of arm pain, stiffness, and function; rapid alternating elbow flexion-extension movement frequency over the maximal range; elbow flexor spasticity grade and angle (Tardieu), and tone (Ashworth). Results No adverse effects were associated with either BoNT/B dose. Both doses improved active elbow extension versus placebo (+8.3°; 95% confidence interval, 1.1°–15.5°; analysis of covariance, P=.028). The high dose of BoNT/B also improved subject-perceived stiffness (P=.005) and the composite pain, stiffness, and function GSA (P=.017), effects that persisted 3 months from injection. No MFS change was demonstrated, although subjects with a baseline MFS Conclusions In this short-term study, BoNT/B up to 15,000U into spastic upper limb muscles, including the elbow flexors, was well tolerated and improved active elbow extension and subject-perceived stiffness. |
| Disponible en ligne : | Oui |
| En ligne : | https://login.ezproxy.vinci.be/login?url=https://www.sciencedirect.com/science/article/pii/S0003999314002561 |
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