A double-blind placebo-controlled study of botulinum toxin in upper limb spasticity after stroke or head injury

Objective: To assess dose-response relationships to a single dose of botuli num toxin 'A' in upper limb spasticity associated with stroke or head Injur y. Design: A double-blind placebo-controlled randomized dose ranging study. Setting: A regional centre for neuroscience and a neurorehabilitation outpa tient clinic. Subjects: Twenty-one hemiplegic patients with troublesome upper limb spasti city. Nineteen with stroke and two with head injury. Main outcome measures: Spasticity (modified Ashworth), range of movement, p osture (postural alignment and finger curl), disability (upper body dressin g time and Frenchay Arm Test), patient-reported global assessment scale. Results: Combining data from all doses of botulinum toxin there was a signi ficant reduction in spasticity at the wrist and fingers associated with a g reater range of passive movement at the wrist and less finger curl at rest. There was a tendency for a further reduction in spasticity at elbow and wr ist to occur with increasing dose but not for finger spasticity or curl. Ef fects present at six weeks were lost by 12 weeks except for a small improve ment in elbow range of movement at the 1500 Mu dose. There was no change in upper limb disability but a significant increase in patients' global asses sment of benefit. Conclusion: Botulinum toxin produced beneficial effects in spasticity and p assive range of movement in the hemiplegic upper limb. Increasing the dose increased the magnitude of response for impairments in some muscle groups b ut had little effect on duration of response.