• Martin K Childers, Allison Brashear, Patricia Jozefczyk, Michael Reding, David Alexander, David Good, Jennifer M Walcott, S W Jenkins, Catherine Turkel, and Patricia T Molloy.
• Dept. of Physical Medicine and Rehabilitation, University of Missouri at Columbia, One Hospital Drive, DCO 46.00, Columbia, MO 65212, USA. ChildersMK@health.missouri.edu
• Arch Phys Med Rehabil. 2004 Jul 1; 85 (7): 1063-9.

ObjectiveTo 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.DesignRandomized, double-blind, placebo-controlled, multicenter, 24-week trial.SettingSix academic and 13 private US outpatient medical centers.ParticipantsNinety-one patients with a mean age of 60 years (range, 30-79 y). Mean time elapsed from ischemic or hemorrhagic stroke to study enrollment was 25.8 months (range, 0.9-226.9 mo).InterventionsUp 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 MeasuresWrist, 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).ResultsMuscle tone decreased more with injections of BTX than with placebo in the wrist flexors at weeks 1, 2, 3, 6, and 9 (P< or =.026); in the elbow flexors at weeks 1, 2, 3, 4, 5, and 9 (P< or =.033); and in the finger flexors at weeks 1 and 3 (P< or =.031). A dose-dependent response was generally observed in tone reduction but not in pain, FIM, or SF-36 measures.ConclusionsIM 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.

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