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: 1,000 units BtxA (Dysport) plus electrical stimulation (A), 1,000 units BtxA (B), placebo plus 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 imb 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 concept that electrical stimulation enhances the effectiveness of BtxA in the treatment of chronic upper limb flexor spasticity after stroke.

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