title: Dose-dependent response to intramuscular botulinum toxin type A for upper-limb spasticity in patients after a stroke.
abstract: 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.
  
  
  METHODS
  Randomized, double-blind, placebo-controlled, multicenter, 24-week trial.
  
  
  METHODS
  Six academic and 13 private US outpatient medical centers.
  
  
  METHODS
  Ninety-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).
  
  
  METHODS
  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.
  
  
  METHODS
  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 (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.
  
  
  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.
authors.affiliation: 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
authors.forename: Martin K
authors.initials: MK
authors.lastname: Childers
authors.forename: Allison
authors.initials: A
authors.lastname: Brashear
authors.forename: Patricia
authors.initials: P
authors.lastname: Jozefczyk
authors.forename: Michael
authors.initials: M
authors.lastname: Reding
authors.forename: David
authors.initials: D
authors.lastname: Alexander
authors.forename: David
authors.initials: D
authors.lastname: Good
authors.forename: Jennifer M
authors.initials: JM
authors.lastname: Walcott
authors.forename: S W
authors.initials: SW
authors.lastname: Jenkins
authors.forename: Catherine
authors.initials: C
authors.lastname: Turkel
authors.forename: Patricia T
authors.initials: PT
authors.lastname: Molloy
mesh_terms: D000328:Adult; D000368:Aged; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004550:Elbow / Q000503:physiopathology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009128:Muscle Spasticity / Q000188:drug therapy* / Q000209:etiology; D018482:Muscle, Skeletal / Q000187:drug effects; D009465:Neuromuscular Agents / Q000008:administration & dosage*; D020521:Stroke / Q000150:complications; D000071939:Stroke Rehabilitation; D014953:Wrist / Q000503:physiopathology
chemical_list: D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A