Dose-dependent response to intramuscular botulinum toxin type A for upper-limb spasticity in patients after a stroke.

Abstract

OBJECTIVE:

To test the hypothesis that intramuscular (IM) botulinum toxin type A (BTX) reduces excessive muscle tone in a dose-dependent manner in the elbow, wrist, and fingers of patients who experience spasticity after a stroke.

DESIGN:

Randomized, double-blind, placebo-controlled, multicenter, 24-week trial.

SETTING:

Six academic and 13 private US outpatient medical centers.

PARTICIPANTS:

Ninety-one patients with a mean age of 60 years (range, 30-79 y). Mean time elapsed from ischemic or hemorrhagic stroke to study enrollment was 25.8 months (range, 0.9-226.9 mo).

INTERVENTIONS:

Up to 2 treatments of placebo, or 90, 180, or 360U of BTX. Concurrent splinting and physical therapy protocols were permitted, but no changes were allowed during the study.

MAIN OUTCOME MEASURES:

Wrist, elbow, and finger flexor tone assessed by the Modified Ashworth Scale, physician and patient global assessments, pain, FIM instrument, and Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36).

RESULTS:

Muscle tone decreased more with injections of BTX than with placebo in the wrist flexors at weeks 1, 2, 3, 6, and 9 (P< or =.026); in the elbow flexors at weeks 1, 2, 3, 4, 5, and 9 (P< or =.033); and in the finger flexors at weeks 1 and 3 (P< or =.031). A dose-dependent response was generally observed in tone reduction but not in pain, FIM, or SF-36 measures.

CONCLUSIONS:

IM BTX reduced muscle tone in a dose-dependent manner in the elbow, wrist, and fingers of patients who experience spasticity after a stroke but did not appear to affect global quality of life or disability.

• Authors: Martin K Childers, Allison Brashear, Patricia Jozefczyk, Michael Reding, David Alexander, David Good, Jennifer M Walcott, S W Jenkins, Catherine Turkel, Patricia T Molloy
• Journal: Archives of physical medicine and rehabilitation (Arch Phys Med Rehabil) Vol. 85 Issue 7 Pg. 1063-9 (Jul 2004) ISSN: 0003-9993 [Print] United States
• PMID: 15241751 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Neuromuscular Agents
• Botulinum Toxins, Type A

Topics

• Adult
• Aged
• Botulinum Toxins, Type A (administration & dosage)
• Dose-Response Relationship, Drug
• Elbow (physiopathology)
• Female
• Humans
• Male
• Middle Aged
• Muscle Spasticity (drug therapy, etiology)
• Muscle, Skeletal (drug effects)
• Neuromuscular Agents (administration & dosage)
• Stroke (complications)
• Stroke Rehabilitation
• Wrist (physiopathology)