The Lack of Effect of Botulinum Toxin-A on Upper Limb Activity in Chronic Stroke: A Short Report from the InTENSE Trial

Toxins (Basel). 2024 Nov 26;16(12):510. doi: 10.3390/toxins16120510.

Abstract

We examined the effect of botulinum toxin-A on upper limb impairments and activity limitations in chronic stroke. This study is a secondary analysis of control group data from a national, multicenter, Phase III randomized trial with a masked outcome assessment. We studied 71 stroke survivors who received a botulinum toxin-A injection in any muscle(s) that crosses the wrist due to significant spasticity after a stroke greater than 3 months previously. We measured upper limb activity, spasticity, range of motion, grip strength, pain and other outcomes at injection and three months later. The median difference between injection and 3 months later was 0.0 blocks/s (interquartile range (IQR) 0.0) on the Box and Block Test, 0/4 (IQR 1) on the Tardieu Scale, 4 degrees (IQR 26) of wrist extension, 0.0 kg (IQR 2) of grip strength, 0.0 (IQR 1.5) on the 10 cm visual analogue scale for pain, 0/100 (IQR 21) on the 10 cm visual analogue scale for overall health, 0/3 (IQR 0) for self-care and -2 (IQR 8) for burden of care. In chronic stroke survivors who have little activity in their upper limb, botulinum toxin-A is not effective in improving any measured outcomes and does not appear to be clinically justified in this population with severe activity limitations.

Keywords: botulinum toxin type-A; movement pain; quality of life; rehabilitation; spasticity; wrist.

Publication types

  • Randomized Controlled Trial
  • Clinical Trial, Phase III
  • Multicenter Study

MeSH terms

  • Aged
  • Botulinum Toxins, Type A* / administration & dosage
  • Botulinum Toxins, Type A* / therapeutic use
  • Chronic Disease
  • Female
  • Hand Strength
  • Humans
  • Male
  • Middle Aged
  • Muscle Spasticity* / drug therapy
  • Muscle Spasticity* / physiopathology
  • Neuromuscular Agents* / therapeutic use
  • Range of Motion, Articular / drug effects
  • Stroke* / drug therapy
  • Stroke* / physiopathology
  • Treatment Outcome
  • Upper Extremity*

Substances

  • Botulinum Toxins, Type A
  • Neuromuscular Agents