Botulinum toxin type A in the treatment of upper extremity spasticity: a randomized, double-blind, placebo-controlled trial.
Spasticity is a disorder of excess muscle tone associated with CNS disease. We hypothesized that botulinum toxin, a neuromuscular blocking agent, would reduce tone in spastic muscles after stroke. This randomized, double-blind, placebo-controlled, multicenter clinical trial evaluated the safety and efficacy of botulinum toxin type A (BTXA) in the treatment of chronic upper limb spasticity after stroke. Thirty-nine patients received IM injections of a total dose of either 75, 150, or 300 units of BTXA or placebo into the biceps, flexor carpi radialis, and flexor carpi ulnaris muscles. At baseline, patients demonstrated a mean wrist flexor tone of 2.9 and elbow flexor tone of 2.6 on the Ashworth Scale (0 to 4). Treatment with the 300-unit BTXA dose resulted in a statistically and clinically significant mean decrease in wrist flexor tone of 1.2 (p = 0.028), 1.1 (p = 0.044), and 1.2 (p = 0.026) points and elbow flexor tone of 1.2 (p = 0.024), 1.2 (p = 0.028), and 1.1 (p = 0.199) at weeks 2, 4, and 6 postinjection. In the placebo group, tone reduction at the wrist was 0.3, 0.2, and 0.0 and at the elbow was 0.3, 0.3, and 0.6 at weeks 2, 4, and 6 postinjection. BTXA groups reported significant improvement on the physician and patient Global Assessment of Response to Treatment at weeks 4 and 6 postinjection. There were no serious adverse effects. In this 3-month study, BTXA safely reduced upper extremity muscle tone in patients with chronic spasticity after stroke.
Simpson
D M
DM
Department of Neurology, Mount Sinai Medical Center, New York, New York, USA.
Alexander
D N
DN
O'Brien
C F
CF
Tagliati
M
M
Aswad
A S
AS
Leon
J M
JM
Gibson
J
J
Mordaunt
J M
JM
Monaghan
E P
EP
D000328:Adult; D000368:Aged; D018726:Anti-Dyskinesia Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001132:Arm; D015982:Bias; D001905:Botulinum Toxins / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004551:Elbow Joint / Q000503:physiopathology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009068:Movement; D009128:Muscle Spasticity / Q000188:drug therapy* / Q000503:physiopathology; D018482:Muscle, Skeletal / Q000503:physiopathology; D018579:Patient Selection; D010919:Placebos; D013997:Time Factors; D014955:Wrist Joint / Q000503:physiopathology
D018726:Anti-Dyskinesia Agents; D010919:Placebos; D001905:Botulinum Toxins