Article

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 degrees ; 95% confidence interval, 1.1 degrees
-15.5 degrees ; 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 <70/100 seemed
more likely to benefit from BoNT/B. 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.
CI - Copyright (c) 2014 American Congress of Rehabilitation Medicine. Published by
Elsevier Inc. All rights reserved.

Langue : ANGLAIS