A Randomized Control Trial of Botulinum Toxin A Administration under Ultrasound Guidance against Manual Palpation in Spastic Cerebral Palsy

Prakruthi S Kaushik, Vykuntaraju K Gowda, Sanjay K Shivappa, Rajeshwari Mannapur, Ajay Jaysheel, Prakruthi S Kaushik, Vykuntaraju K Gowda, Sanjay K Shivappa, Rajeshwari Mannapur, Ajay Jaysheel

Abstract

Background: Botulinum toxin A is established as an effective treatment to reduce spasticity in cerebral palsy (CP). But very little data are available regarding the techniques of administration. Hence, this study was conducted to compare administration of botulinum toxin with and without ultrasound.

Materials and methods: This is a randomized trial conducted for 2 years at a tertiary care hospital in children aged up to 6 years with CP. Children were assessed with range of ankle dorsiflexion, Modified Ashworth Scale (MAS), and Gross Motor Function Measure 66(GMFM 66) before and after administration. They were followed up for 6 months.

Results: Of the 180 children screened, 30 who met the criteria were included. Those enrolled in the study were categorized into group I and group II, children who were given botulinum toxin with ultrasound (n = 14) and without ultrasound (n = 16), respectively. Results showed a significant increase in ankle dorsiflexion in both groups (P ≤ 0.005) but no significant difference was reported between the groups (P = 0.4). A statistically significant increase in GMFM scores (P ≤ 0.005) during sequential assessment was observed in both groups, but no significant difference was observed in the GMFM scores between the groups (P = 0.45). Majority of children improved by a scale of 2 (MAS) from baseline in groups after 12 weeks, 50% in group I and 57.9% in group II.

Conclusion: No significant difference was observed in the outcome with regard to technique of administration of botulinum toxin with ultrasound and without ultrasound into gastrocnemius muscle.

Keywords: Botulinum toxin A; cerebral palsy; ultrasonography.

Conflict of interest statement

There are no conflicts of interest.

Figures

Figure 1
Figure 1
Flow diagram of the progress through the phases of a parallel randomized trial of two groups

References

    1. Johnson MV. Cerebral palsy. In: Kleigman RM, Stanton B, Geme J, Schor N, Behrman R, editors. Nelson textbook of pediatrics. 19th ed. Philadelphia, PA: Elsevier; 2011. pp. 2061–3.
    1. Data and statistics for cerebral palsy. Atlanta, GA: The Centers for Disease Control and Prevention; 2008. The Centers for Disease Control and Prevention (CDC)
    1. Delgado MR, Hirtz D, Aisen M, Ashwal S, Fehlings DL, Mclaughlin J, et al. Practice parameter: pharmacologic treatment of spasticity in children and adolescents with cerebral palsy (an evidence-based review) Neurology. 2010;74:336–43.
    1. Simpson DM, Gracies JM, Graham HK, Miyasaki JM, Naumann M, Russman B, et al. ; Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Assessment: botulinum neurotoxin for the treatment of spasticity (an evidence-based review): report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2008;70:1691–8.
    1. Heinen F, Molenaers G, Fairhurst C, Carr LJ, Desloovere K, Valayer EC. European consensus table 2006 on botulinum toxin for children with cerebral palsy. Eur J Paediatr Neurol. 2006;10:215–25.
    1. Lovea SC, Novakb I, Kentishc M, Desloovered K, Heinene F, Molenaersf G, et al. Botulinum toxin assessment, intervention and after-care for lower limb spasticity in children with cerebral palsy: international consensus statement. Eur J Neurol. 2010;17:9–37.
    1. Palisano R, Rosenbaum P, Walter S, Russell D, Wood E, Galuppi B. Development and reliability of a system to classify gross motor function in children with cerebral palsy. Dev Med Child Neurol. 1997;39:214–23.
    1. Hodgkinson I, Berard C. Assessment of spasticity in pediatric patients. Oper Tech Neuro. 2005;7:109–11.
    1. Russell DJ, Rosenbaum PL, Avery LM, Lane M. Gross motor function measure (GMFM-66 and GMFM-88) Cambridge, UK: Mac Keith Press; 2002.
    1. Meholjic A, Madjar D. Application of botulinum toxin in treatment of spasticity and functional improvements for children suffering from cerebral palsy. Med Arh. 2010;64:359–61.
    1. Lukban MB, Rosales RL, Dressler D. Effectiveness of botulinum toxin A for upper and lower limb spasticity in children with cerebral palsy: a summary of evidence. J Neural Transm (Vienna) 2009;116:319–31.
    1. Py AG, Zein Addeen G, Perrier Y, Carlier RY, Picard A. Evaluation of the effectiveness of botulinum toxin injections in the lower limb muscles of children with cerebral palsy. Preliminary prospective study of the advantages of ultrasound guidance. Ann Phys Rehabil Med. 2009;52:215–23.
    1. Schroeder AS, Berweck S, Lee SH, Heinen F. Botulinum toxin treatment of children with cerebral palsy—a short review of different injection techniques. Neurotox Res. 2006;9:189–96.
    1. Berweck S, Schroeder AS, Fietzek UM, Heinen F. Sonography-guided injection of botulinum toxin in children with cerebral palsy. Lancet. 2004;363:249–50.
    1. Berweck S, Feldkamp A, Francke A, Nehles J, Schwerin A, Heinen F. Sonography-guided injection of botulinum toxin A in children with cerebral palsy. Neuropediatrics. 2002;33:221–3.

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