Botulinum toxin type B in upper-limb poststroke spasticity

A double-blind, placebo-controlled trial

Allison Brashear, Anita L. McAfee, Elizabeth R. Kuhn, Joanne Daggy

Research output: Contribution to journalArticle

76 Citations (Scopus)

Abstract

Brashear A, McAfee AL, Kuhn ER, Fyffe J. Botulinum toxin type B in upper-limb poststroke spasticity: a double-blind, placebo-controlled trial. Arch Phys Med Rehabil 2004;85:705-9. Objective To determine whether botulinum toxin type B (BTX-B) is effective in controlling upper-limb spasticity. Design A single-site, double-blind, placebo-controlled, randomized trial and open-label study. Setting Outpatient. Participants Subjects with an Ashworth Scale score of 2 or more at the elbow, wrist, and fingers. Interventions Subjects were injected with 10,000U of BTX-B or placebo at the elbow, wrist, and finger flexors. Main outcome measures Measures recorded at weeks 0, 2, 4, 8, 12, and 16, with a 12-week open-label study. Ashworth Scale score, a global assessment of change (GAC), adverse events and mouse neutralization antibody testing. Results BTX-B did not decrease muscle tone in the elbow, wrist, or finger flexors at 10,000U over the 16-week period. A decrease in Ashworth Scale score for the BTX-B patient group was present at the wrist at week 2 of the double-blind study (P=.003) but was not statistically significant at other visits. In the open-label study, improvement was noted at week 4 for the elbow (P=.039), wrist (P=.002), finger (P=.001), and thumb flexors (P=.002). In the double-blind study, the Physician GAC did not reach significance. Dry mouth was reported by 8 of 9 BTX-B subjects in the double-blind study. Mouse neutralization antibodies were negative. Conclusions Our study does not show a significant decrease in tone from 10,000U of BTX-B. Dry mouth was common.

Original languageEnglish
Pages (from-to)705-709
Number of pages5
JournalArchives of Physical Medicine and Rehabilitation
Volume85
Issue number5
DOIs
StatePublished - May 2004

Fingerprint

Upper Extremity
Wrist
Placebos
Elbow
Fingers
Double-Blind Method
Mouth
Antibodies
Thumb
rimabotulinumtoxinB
Outpatients
Randomized Controlled Trials
Outcome Assessment (Health Care)
Physicians
Muscles

Keywords

  • Botulinum toxins
  • Muscle spasticity
  • Rehabilitation
  • Stroke

ASJC Scopus subject areas

  • Rehabilitation

Cite this

Botulinum toxin type B in upper-limb poststroke spasticity : A double-blind, placebo-controlled trial. / Brashear, Allison; McAfee, Anita L.; Kuhn, Elizabeth R.; Daggy, Joanne.

In: Archives of Physical Medicine and Rehabilitation, Vol. 85, No. 5, 05.2004, p. 705-709.

Research output: Contribution to journalArticle

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abstract = "Brashear A, McAfee AL, Kuhn ER, Fyffe J. Botulinum toxin type B in upper-limb poststroke spasticity: a double-blind, placebo-controlled trial. Arch Phys Med Rehabil 2004;85:705-9. Objective To determine whether botulinum toxin type B (BTX-B) is effective in controlling upper-limb spasticity. Design A single-site, double-blind, placebo-controlled, randomized trial and open-label study. Setting Outpatient. Participants Subjects with an Ashworth Scale score of 2 or more at the elbow, wrist, and fingers. Interventions Subjects were injected with 10,000U of BTX-B or placebo at the elbow, wrist, and finger flexors. Main outcome measures Measures recorded at weeks 0, 2, 4, 8, 12, and 16, with a 12-week open-label study. Ashworth Scale score, a global assessment of change (GAC), adverse events and mouse neutralization antibody testing. Results BTX-B did not decrease muscle tone in the elbow, wrist, or finger flexors at 10,000U over the 16-week period. A decrease in Ashworth Scale score for the BTX-B patient group was present at the wrist at week 2 of the double-blind study (P=.003) but was not statistically significant at other visits. In the open-label study, improvement was noted at week 4 for the elbow (P=.039), wrist (P=.002), finger (P=.001), and thumb flexors (P=.002). In the double-blind study, the Physician GAC did not reach significance. Dry mouth was reported by 8 of 9 BTX-B subjects in the double-blind study. Mouse neutralization antibodies were negative. Conclusions Our study does not show a significant decrease in tone from 10,000U of BTX-B. Dry mouth was common.",
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