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

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Abstract
Objective: To investigate whether the combined approach of botulinum toxin type A (BtxA) and electrical stimulation was more effective than the toxin alone in the treatment of chronic upper limb spasticity after stroke. Design: Randomized, placebo-controlled study with four treatment groups: 1000 units BtxA (Dysport®) + electrical stimulation (A), 1000 units BtxA (B), placebo + electrical stimulation (C) and placebo (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 injection of either toxin or placebo into six upper limb flexor muscles. In group A and C additional electrical stimulation of the injected muscles with surface electrodes, three times half an hour each day for three days. Main outcome measures: Muscle tone rated with the modified Ashworth score, limb position at rest and difficulties encountered during 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. Pairwise 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). Conclusions: The placebo-controlled trial favours the conceptthat electrical stimulation enhances the effectiveness of BtxA in the treatment of chronic upper limb flexor spasticity after stroke.