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.


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.
Childers
Martin K
MK
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
Brashear
Allison
A
Jozefczyk
Patricia
P
Reding
Michael
M
Alexander
David
D
Good
David
D
Walcott
Jennifer M
JM
Jenkins
S W
SW
Turkel
Catherine
C
Molloy
Patricia T
PT
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
D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A