title: Early botulinum toxin treatment for spastic pes equinovarus--a randomized double-blind placebo-controlled study.
abstract: OBJECTIVE
  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.affiliation: Department of Neurology and Clinical Neurophysiology, Schön Klinik München Schwabing, Munich, Germany.
authors.forename: U M
authors.initials: UM
authors.lastname: Fietzek
authors.affiliation: Kliniken Beelitz, Neurological Rehabilitation Medical Centre, Beelitz-Heilstätten, Germany.
authors.forename: P
authors.initials: P
authors.lastname: Kossmehl
authors.affiliation: Department of Neurology, Kantonsspital Münsterlingen, Münsterlingen, Switzerland.
authors.forename: L
authors.initials: L
authors.lastname: Schelosky
authors.affiliation: Kliniken Beelitz, Parkinson's Disease and Movement Disorders, Beelitz-Heilstätten, Germany.
authors.forename: G
authors.initials: G
authors.lastname: Ebersbach
authors.affiliation: Department of Neurological Rehabilitation and Physical Medicine, Vivantes Klinikum Spandau, Berlin, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Wissel
mesh_terms: D000328:Adult; D000368:Aged; D000818:Animals; D001905:Botulinum Toxins / Q000627:therapeutic use; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage / Q000494:pharmacology*; D003025:Clubfoot / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006736:Horses; D006801:Humans; D008297:Male; D008875:Middle Aged; D009128:Muscle Spasticity / Q000188:drug therapy*; D009465:Neuromuscular Agents / Q000008:administration & dosage / Q000494:pharmacology*; D016896:Treatment Outcome
chemical_list: D009465:Neuromuscular Agents; D001905:Botulinum Toxins; D019274:Botulinum Toxins, Type A
keywords: Ashworth scale; botulinum toxin; pes equinovarus; randomized controlled trial; spasticity