Botulinum toxin injection for hypertonicity of the upper extremity within 12 weeks after stroke: a randomized controlled trial

Neurorehabil Neural Repair. 2012 Sep;26(7):812-21. doi: 10.1177/1545968311430824. Epub 2012 Feb 27.

Abstract

Background: Botulinum neurotoxin type A (BoNT-A) reduces upper-extremity poststroke spasticity when given 6 or more months after stroke. Effects on functional use of the arm and hand are less apparent.

Objective: To determine the effect and safety of very early use of BoNT-A for patients with upper-limb spasticity.

Methods: The Asia Botulinum Toxin-A Clinical Trial

Design: ed 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.

Results: 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. Interpretation. 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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Botulinum Toxins, Type A / administration & dosage*
  • Botulinum Toxins, Type A / adverse effects
  • Double-Blind Method
  • Elbow Joint
  • Female
  • Humans
  • Injections, Intra-Articular
  • Male
  • Middle Aged
  • Muscle Spasticity / diagnosis
  • Muscle Spasticity / drug therapy*
  • Muscle Spasticity / etiology
  • Neuromuscular Agents / administration & dosage*
  • Neuromuscular Agents / adverse effects
  • Placebos
  • Severity of Illness Index
  • Stroke / complications*
  • Stroke / drug therapy
  • Stroke Rehabilitation
  • Time Factors
  • Treatment Outcome
  • Upper Extremity / physiopathology*
  • Wrist Joint

Substances

  • Neuromuscular Agents
  • Placebos
  • Botulinum Toxins, Type A