See editorial by Ward on page 1053.
Early botulinum toxin treatment for spastic pes equinovarus – a randomized double-blind placebo-controlled study
Article first published online: 12 FEB 2014
© 2014 The Author(s) European Journal of Neurology © 2014 EAN
European Journal of Neurology
Volume 21, Issue 8, pages 1089–1095, August 2014
How to Cite
Fietzek, U. M., Kossmehl, P., Schelosky, L., Ebersbach, G. and Wissel, J. (2014), Early botulinum toxin treatment for spastic pes equinovarus – a randomized double-blind placebo-controlled study. European Journal of Neurology, 21: 1089–1095. doi: 10.1111/ene.12381
- Issue published online: 8 JUL 2014
- Article first published online: 12 FEB 2014
- Manuscript Accepted: 17 DEC 2013
- Manuscript Received: 5 AUG 2013
- PharmAllergan GmbH, Ettlingen, Germany
- Ashworth scale;
- botulinum toxin;
- pes equinovarus;
- randomized controlled trial;
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.
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.
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).
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.