BOTULINUM TOXIN TYPE-A AND SHORT-TERM ELECTRICAL-STIMULATION IN THE TREATMENT OF UPPER-LIMB FLEXOR SPASTICITY AFTER STROKE - A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL

Objective: To investigate whether the combined approach of botulinum t oxin type A (BtxA) and electrical stimulation was more effective than the toxin alone in the treatment of chronic upper limb spasticity afte r stroke. Design: Randomized, placebo-controlled study with four treat ment groups: 1000 units BtxA (Dysport(R)) + electrical stimulation (A) , 1000 units BtxA (B), placebo + electrical stimulation (C) and placeb o (D). Setting: A neurological rehabilitation clinic. Subjects: Twenty -four stroke patients with chronic upper limb spasticity after stroke, six patients in each treatment group. Interventions: Intramuscular in jection of either toxin or placebo into six upper limb flexor muscles. In group A and C additional electrical stimulation of the injected mu scles with surface electrodes, three times half an hour each day for t hree days. Main outcome measures: Muscle tone rated with the modified Ashworth score, limb position at rest and difficulties encountered dur ing three upper limb motor tasks assessed before and 2, 6 and 12 weeks after injection. Results: Most improvements were observed in patients of group A. Cleaning the palm (p = 0.004) differed across groups. Pai rwise comparison for this target variable showed that group A differed from group B and D (p <0.01), but not from C. indicative across-group differences were obtained for elbow spasticity reduction (p = 0.011), and improvement of putting the arm through a sleeve (p = 0.020). Conc lusions: The placebo-controlled trial favours the concept that electri cal stimulation enhances the effectiveness of BtxA in the treatment of chronic upper limb flexor spasticity after stroke.