Dose-dependent response to intramuscular botulinum toxin type A for upper-limb spasticity in patients after a stroke

Objective: To test the hypothesis that intramuscular (IM) botulinum toxin type A (BTX) reduces excessive muscle tone in a dose-dependent manner in the elbow, wrist, and fingers of patients who experience spasticity after a stroke. Design: Randomized, double-blind, placebo-controlled, multicenter, 24-week trial. Setting: Six academic and 13 private US outpatient medical centers. Participants: Ninety-one patients with a mean age of 60 years (range, 30-79y). Mean time elapsed from ischemic or hemorrhagic stroke to study enrollment was 25.8 months (range, 0.9-226.9mo). Interventions: Up to 2 treatments of placebo, or 90, 180, or 360U of BTX. Concurrent splinting and physical therapy protocols were permitted, but no changes were allowed during the study. Main Outcome Measures: Wrist, elbow, and finger flexor tone assessed by the Modified Ashworth Scale, physician and patient global assessments, pain, FIM instrument, and Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). Results: Muscle tone decreased more with injections of BTX than with placebo in the wrist flexors at weeks 1, 2, 3, 6, and 9 (Pless than or equal to.026); in the elbow flexors at weeks 1, 2, 3, 4, 5, and 9 (Pless than or equal to.033); and in the finger flexors at weeks 1 and 3 (Pless than or equal to.031). A dose-dependent response was generally observed in tone reduction but not in pain, FIM, or SF-36 measures. Conclusions: IM BTX reduced muscle tone in a dose-dependent manner in the elbow, wrist, and fingers of patients who experience spasticity after a stroke but did not appear to affect global quality of life or disability. (C) 2004 by the American Congress of Rehabilitation Medicine and the American Academy of Physical Medicine and Rehabilitation.