Early botulinum toxin treatment for spastic pes equinovarus--a randomized double-blind placebo-controlled study.

Abstract

BACKGROUND AND PURPOSE:

Spastic pes equinovarus is a frequent pathological posture of the lower extremity. Botulinum toxin (BoNT/A) has been successfully applied to treat lower limb spasticity. However, the best time to initiate treatment remains unclear. A beneficial effect of an early treatment has been suggested in previous studies.

METHODS:

A single-centre double-blind randomized placebo-controlled trial was performed to investigate the efficacy of BoNT/A to reduce muscle hypertonicity at the ankle. Fifty-two patients with unilateral or bilateral spastic pes equinovarus with a modified Ashworth score (mAS) of at least 1+ after stroke, traumatic brain injury or hypoxic encephalopathy were allocated to receive either BoNT/A or placebo treatment. A second, open injection was optional at week 12. Patients received unilateral or bilateral injections with 230 or 460 U onabotulinumtoxinA, respectively. The course of the mAS was explored during the open study phase.

RESULTS:

Patients who had received BoNT/A treatment had lower mAS compared with placebo at week 12 (P < 0.01). During the open label phase, patients from the placebo group showed further deterioration of muscle tone despite starting from a similar baseline and receiving BoNT treatment. Spastic feet that had received BoNT/A in the first cycle had comparatively lower mAS scores over all follow-up data and at week 24 (P < 0.01).

CONCLUSIONS:

The study demonstrates a reduction of muscular hypertonicity in spastic pes equines with BoNT/A treatment given during the first 3 months after the lesion. Exploratory analyses of the course of muscular hypertonicity during the open phase favour earlier to later treatment.

• Authors: U M Fietzek, P Kossmehl, L Schelosky, G Ebersbach, J Wissel
• Journal: European journal of neurology (Eur J Neurol) Vol. 21 Issue 8 Pg. 1089-1095 (Aug 2014) ISSN: 1468-1331 [Electronic] England
• PMID: 24754350 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2014 The Author(s) European Journal of Neurology © 2014 EAN.

Chemical References

• Neuromuscular Agents
• Botulinum Toxins
• Botulinum Toxins, Type A

Topics

• Adult
• Aged
• Animals
• Botulinum Toxins (therapeutic use)
• Botulinum Toxins, Type A (administration & dosage, pharmacology)
• Clubfoot (drug therapy)
• Double-Blind Method
• Female
• Horses
• Humans
• Male
• Middle Aged
• Muscle Spasticity (drug therapy)
• Neuromuscular Agents (administration & dosage, pharmacology)
• Treatment Outcome