A randomized control trial of botulinum toxin A administration under ultrasound guidance against manual palpation in spastic cerebral palsy

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.