Botulinum Toxin A Does Not Improve the Results of Cast Treatment for Idiopathic Toe-Walking A Randomized Controlled Trial P¨ ahr Engstr¨ om, MD, ˚ Asa Bartonek, PT, PhD, Kristina Tedroff, MD, PhD, Christina Orefelt, PT, Yvonne Haglund- ˚ Akerlind, MD, PhD, and Elena M. Gutierrez-Farewik, PhD Investigation performed at Karolinska Institutet, Stockholm, Sweden 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. Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence. S everal types of treatment have been suggested for idiopathic toe-walking, such as physical therapy 1 , serial casts 1-4 , and open or percutaneous Achilles tendon lengthening 1,5-8 . Bot- ulinum toxin A was first introduced for pediatric use in patients with spasticity, typically associated with cerebral palsy, in the early 1990s 9,10 . Subsequently, the suggested indications for botulinum Disclosure: One or more of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of an aspect of this work. In addition, one or more of the authors, or his or her institution, has had a financial relationship, in the thirty-six months prior to submission of this work, with an entity in the biomedical arena that could be perceived to influence or have the potential to influ- ence what is written in this work. No author has had any other relation- ships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article. A commentary by Henry G. Chambers, MD, is linked to the online version of this article at jbjs.org. 400 COPYRIGHT Ó 2013 BY THE J OURNAL OF BONE AND J OINT SURGERY,I NCORPORATED J Bone Joint Surg Am. 2013;95:400-7 d http://dx.doi.org/10.2106/JBJS.L.00889