A randomised, double blind, placebo controlled trial of botulinum toxin in the treatment of spastic foot in hemiparetic patients

J Neurol Neurosurg Psychiatry. 1996 Sep;61(3):265-9. doi: 10.1136/jnnp.61.3.265.

Abstract

Objective: To confirm the apparent effectiveness of botulinum toxin (BTX) in hemiparetic patients with ankle plantar flexors and foot invertor spasticity.

Methods: Twenty three hemiparetic patients with spasticity of the ankle plantar flexors and foot invertors were included in a randomised double blind, placebo controlled study with BTX. Patients were examined on days 0, 30, 90, and 120 and received one injection of BTX and one of placebo in a random order at day 0 and day 90.

Results: Patients reported a clear subjective improvement in foot spasticity after BTX (P = 0.0014) but not after placebo. Significant changes were noted in Ashworth scale values for ankle extensors (P < 0.0001) and invertors (P = 0.0002), and for active ankle dorsiflexion (P = 0.0001). Gait velocity was slightly but not significantly (P = 0.0731) improved after BTX injections. The severity of spasticity did not modify treatment efficacy, but BTX was less effective in patients with longer duration of spasticity (P = 0.0081).

Conclusion: The efficacy of BTX injections in the treatment of spastic foot suggests that BTX may be particularly useful during the first year after a stroke.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Botulinum Toxins / therapeutic use*
  • Double-Blind Method
  • Female
  • Foot Diseases / drug therapy*
  • Foot Diseases / etiology
  • Foot Diseases / physiopathology
  • Hemiplegia / complications*
  • Hemiplegia / rehabilitation
  • Humans
  • Male
  • Middle Aged
  • Neuromuscular Agents / therapeutic use*
  • Placebos
  • Severity of Illness Index
  • Spasm / drug therapy*
  • Spasm / etiology
  • Spasm / physiopathology

Substances

  • Neuromuscular Agents
  • Placebos
  • Botulinum Toxins