Botulinum toxin A does not improve the results of cast treatment for idiopathic toe-walking: a randomized controlled trial

J Bone Joint Surg Am. 2013 Mar 6;95(5):400-7. doi: 10.2106/JBJS.L.00889.

Abstract

Background: There are many treatments for idiopathic toe-walking, including casts with or without injection of botulinum toxin A. Combined treatment with casts and botulinum toxin A has become more common even though there have been few studies of its efficacy and safety problems. Our aims were to conduct a randomized controlled trial to test the hypotheses that combined treatment with casts and botulinum toxin A is more effective than casts alone in reducing toe-walking by patients five to fifteen years of age, and that the treatment effect correlates with the extent of coexisting neuropsychiatric problems.

Methods: All patients who had been consecutively admitted to the pediatric orthopaedics department of our institution because of idiopathic toe-walking between November 2005 and April 2010 were considered for inclusion in the study. Forty-seven children constituted the study population. The children were randomized to undergo four weeks of treatment with below-the-knee casts either as the sole intervention or to undergo the cast treatment one to two weeks after receiving injections of botulinum toxin A into the calves. Before treatment and three and twelve months after cast removal, all children underwent three-dimensional (3-D) gait analysis. The severity of the idiopathic toe-walking was classified on the basis of the gait analysis, and the parents rated the time that their child spent on his/her toes during barefoot walking. Passive hip, knee, and ankle motion as well as ankle dorsiflexor strength were measured. Before treatment, all children were evaluated with a screening questionnaire for neuropsychiatric problems.

Results: No differences were found in any outcome parameter between the groups before treatment or at three or twelve months after cast removal. Several gait-analysis parameters, passive ankle motion, and ankle dorsiflexor strength were improved at both three and twelve months in both groups, even though many children still demonstrated some degree of toe-walking. The treatment outcomes were not correlated with coexisting neuropsychiatric problems.

Conclusion: Adding botulinum toxin-A injections prior to cast treatment for idiopathic toe-walking does not improve the outcome of cast-only treatment.

Trial registration: ClinicalTrials.gov NCT01590693.

Publication types

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

MeSH terms

  • Adolescent
  • Ankle Joint / physiology
  • Botulinum Toxins, Type A / administration & dosage
  • Botulinum Toxins, Type A / pharmacology*
  • Casts, Surgical*
  • Child
  • Child, Preschool
  • Drug Administration Schedule
  • Female
  • Follow-Up Studies
  • Gait / drug effects*
  • Gait / physiology
  • Humans
  • Injections, Intramuscular
  • Intention to Treat Analysis
  • Male
  • Neuromuscular Agents / administration & dosage
  • Neuromuscular Agents / pharmacology*
  • Neuropsychological Tests
  • Outcome Assessment, Health Care
  • Range of Motion, Articular / drug effects
  • Surveys and Questionnaires
  • Toes*

Substances

  • Neuromuscular Agents
  • Botulinum Toxins, Type A

Associated data

  • ClinicalTrials.gov/NCT01590693