• J Rehabil Med · Jun 2009

    Randomized Controlled Trial Multicenter Study

    Botulinum toxin A for treatment of upper limb spasticity following stroke: a multi-centre randomized placebo-controlled study of the effects on quality of life and other person-centred outcomes.

    • Paul McCrory, Lynne Turner-Stokes, Ian J Baguley, Stephen De Graaff, Pesi Katrak, Joseph Sandanam, Leo Davies, Melinda Munns, and Andrew Hughes.
    • Box Hill Hospital & Melbourne University, Melbourne, Australia.
    • J Rehabil Med. 2009 Jun 1;41(7):536-44.

    ObjectiveBotulinum toxin is known to relieve upper limb spasticity, which is a disabling complication of stroke. We examined its effect on quality of life and other person-centred perspectives.DesignA multi-centre, randomized, double-blind, placebo-controlled study.PatientsNinety-six patients were randomized (mean age 59.5 years) at least 6 months post-stroke. Mean time since stroke was 5.9 years.MethodsPatients received either botulinum toxin type A or placebo into the affected distal upper limb muscles on 2 occasions, 12 weeks apart. Assessment was undertaken at baseline, 8, 12, 20 and 24 weeks. The primary outcome measure was the Assessment of Quality of Life scale (AQoL). Secondary outcome assessments included Goal Attainment Scaling (GAS), pain, mood, global benefit, Modified Ashworth Scale (MAS), disability and carer burden.ResultsThe groups did not differ significantly with respect to quality of life, pain, mood, disability or carer burden. However, patients treated with botulinum toxin type A had significantly greater reduction in spasticity (MAS) (p < 0.001), which translated into higher GAS scores (p < 0.01) and greater global benefit (p < 0.01).ConclusionAlthough no change in quality of life was demonstrated using the AQoL, botulinum toxin type A was found to be safe and efficacious in reducing upper limb spasticity and improving the ability to achieve personal goals.

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