Botulinum Toxin Injection for Hypertonicity of the Upper Extremity Within 12 Weeks After Stroke: A Randomized Controlled Trial
Neurorehabilitation and Neural Repair, 08/09/2012
Rosales RL et al. – Botulinum neurotoxin type A (BoNT–A) 500 U can provide a sustained reduction in poststroke upper–limb spasticity when combined with rehabilitation in Asian patients who have mild–to–moderate hypertonicity and voluntary movement, within 2 –12 weeks of stroke. Functional use of the arm and hand was not affected.Methods
- The Asia Botulinum Toxin-A Clinical Trial Designed for Early Post-stroke Spasticity (ABCDE-S; NCT00234546) was a multicenter, randomized, placebo-controlled trial conducted in patients recruited within 2 -12 weeks of first-ever stroke.
- Participants with a Modified Ashworth Scale (MAS) score of 1+ or above received BoNT-A (Dysport) 500 U or placebo to one or more wrist and elbow mover muscles, plus unstructured rehabilitation.
- The primary outcome was the MAS score in the most affected joint 4 weeks after first injection.
- Follow-up was 24 weeks.
- A total of 163 patients were enrolled and assigned to placebo (n=83) or BoNT-A (n=80).
- Mean time since stroke was about 7 weeks.
- At 4 weeks postinjection, BoNT-A significantly improved MAS scores.
- Treatment effect-size estimates increased with higher baseline MAS scores from 0.45 (Q1) to 0.70 (Q3).
- MAS scores for all secondary end points improved with BoNT-A versus placebo at all time points (P<.0001, all visits).
- The Functional Motor Assessment Scale did not reveal clinically significant differences. No group differences in adverse events were found.