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A correction has been published: N Engl J Med 2003;348(3):258.

Original Article
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Volume 347:395-400 August 8, 2002 Number 6
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Intramuscular Injection of Botulinum Toxin for the Treatment of Wrist and Finger Spasticity after a Stroke
Allison Brashear, M.D., Mark F. Gordon, M.D., Elie Elovic, M.D., V. Daniel Kassicieh, D.O., Christina Marciniak, M.D., Mai Do, B.S., Chia-Ho Lee, M.S., Stephen Jenkins, M.D., Catherine Turkel, Pharm.D., for the Botox Post-Stroke Spasticity Study Group

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ABSTRACT

Background Spasticity is a disabling complication of stroke, and it is uncertain whether intramuscular injections of botulinum toxin type A reduce disability in persons with spasticity of the wrist and fingers after a stroke.

Methods We performed a randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of one-time injections of botulinum toxin A (200 to 240 units) in 126 subjects with increased flexor tone in the wrist and fingers after a stroke. The primary outcome measure was self-reported disability in four areas: personal hygiene, dressing, pain, and limb position (on a four-point scale ranging from no disability to severe disability) at six weeks; at base line, each subject selected one of these areas in which there was moderate-to-severe disability as the principal target of treatment.

Results Subjects who received botulinum toxin A had greater improvement in flexor tone in the wrist and fingers at all follow-up visits through 12 weeks than did subjects who received placebo (P<0.001 for all comparisons). Subjects treated with botulinum toxin A had greater improvement in the principal target of treatment at weeks 4, 6, 8, and 12 (P<0.001, P<0.001, P=0.03, and P=0.02, respectively); at week 6, 40 of the 64 subjects in the botulinum-toxin group (62 percent), as compared with 17 of the 62 in the placebo group (27 percent), reported improvement of at least one point on the Disability Assessment Scale in the principal target of treatment (P<0.001). There were no major adverse events associated with injection of botulinum toxin A.

Conclusions Intramuscular injections of botulinum toxin A reduce spasticity of the wrist and finger muscles and associated disability in patients who have had a stroke.


Source Information

From the Department of Neurology, Indiana University School of Medicine, Indianapolis (A.B.); the Department of Neurology and Psychiatry, Long Island Jewish Medical Center, New Hyde Park, N.Y. (M.F.G.); Traumatic Brain Injury Research Laboratory, Kessler Medical Rehabilitation Research Education Corporation, West Orange, N.J. (E.E.); the Neurological Research Institute of Sarasota, Sarasota, Fla. (V.D.K.); the Rehabilitation Institute of Chicago, Chicago (C.M.); and Allergan, Irvine, Calif. (M.D., C.-H.L., S.J., C.T.).

Address reprint requests to Dr. Brashear at Indiana University Hospital, Department of Neurology, 550 University Blvd., Rm. 6620, Indianapolis, IN 46202, or at abrashea{at}iupui.edu.

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Related Letters:

Botulinum Toxin for Spasticity after Stroke
Landau W. M., Dobkin B. H., Buitrago M. M., Koolwijk I., Brashear A., Gordon M. F.
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N Engl J Med 2003; 348:258-259, Jan 16, 2003. Correspondence

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