Article

OBJECTIVE: To examine the safety and efficacy of onabotulinumtoxinA (Botox) for
plantarflexor overactivity following stroke. DESIGN: Double-blind randomized
controlled trial, open-label extension phase. SETTING: Neurology rehabilitation
facilities. SUBJECTS:
Eighty-five subjects with lower limb hypertonia received
200 U (n = 28) or 300 U (n = 28) of onabotulinumtoxinA or saline (n = 29)
injection. PRIMARY MEASURES: Plantarflexor Ashworth scores at 12 weeks post
injection and adverse events. Secondary measures: self-reported spasm frequency
and pain, physician rating of hypertonia severity, gait quality and active
dorsiflexion. RESULTS: Differences were not seen between onabotulinumtoxinA
groups; hence data were pooled. Incidence of adverse events was not different
between groups (P = 0.61). Reduction in hypertonia was not different between
groups at 12 weeks (P = 0.53); however for subjects with Ashworth scores of >3 at
baseline, 14/31 in the onabotulinumtoxinA group demonstrated a reduction of >1
grade versus 1/17 receiving placebo injection (P = 0.01). Overall,
onabotulinumtoxinA-injected subjects demonstrated significantly greater
improvement in spasm frequency (22/54 versus 4/29, P = 0.01), pain reduction
(8/54 versus 1/29, P = 0.02), active dorsiflexion (8/54 versus 1/29 P = 0.03) and
gait quality (17/54 versus 6/29, P = 0.02) than controls. In the open-label
phase, a second onabotulinumtoxinA injection was associated with greater
hypertonia reduction (P = 0.005) and gait quality (P = 0.002) compared with single injection. CONCLUSIONS: OnabotulinumtoxinA injection for ankle flexor
overactivity after stroke was safe and well tolerated but did not alter local
spasticity at 12 weeks; it did reduce spasms and improve gait quality. There were
no detectable differences between higher and lower doses. A second injection may
be associated with greater change.

Langue : ANGLAIS