OBJECTIVE: To explore the clinical relevance of injection site by comparing two different injection techniques in children with cerebral palsy who have spastic equinus gait. DESIGN: A total of 19 children (13 boys, 6 girls; range, 1 yr 6 mos to 7 yrs; nine hemiplegics, eight diplegics, two quadriplegics; levels I to IV with the Gross Motor Function Classification System) participated in the study. The children were randomized into two groups: the proximal group received a botulinum toxin A injection into the proximal part of both heads of the gastrocnemius, and the distal group received a botulinum toxin A injection into the mid-belly of the muscle bulks. A single-point injection of BOTOX, 3 units/kg per site, was used. Assessments of active and passive range of motion, dynamic muscle length (modified Tardieu scale), calf tone (modified Ashworth scale), and video gait analysis (Observational Gait Scale) were performed before treatment and 3, 8, and 16 wks posttreatment. RESULTS:Active and passive dorsiflexion and calf tone in both groups and Observational Gait Scale total scores in the distal group improved at all time points. The median change from baseline values in Observational Gait Scale initial foot contact and total scores at 8 wks showed a significant difference favoring the distal group, but the clinical relevance remained tenuous. CONCLUSIONS: Using the methods described, no major changes in main outcome measures were associated with changing the injection site.
RCT Entities:
OBJECTIVE: To explore the clinical relevance of injection site by comparing two different injection techniques in children with cerebral palsy who have spastic equinus gait. DESIGN: A total of 19 children (13 boys, 6 girls; range, 1 yr 6 mos to 7 yrs; nine hemiplegics, eight diplegics, two quadriplegics; levels I to IV with the Gross Motor Function Classification System) participated in the study. The children were randomized into two groups: the proximal group received a botulinum toxin A injection into the proximal part of both heads of the gastrocnemius, and the distal group received a botulinum toxin A injection into the mid-belly of the muscle bulks. A single-point injection of BOTOX, 3 units/kg per site, was used. Assessments of active and passive range of motion, dynamic muscle length (modified Tardieu scale), calf tone (modified Ashworth scale), and video gait analysis (Observational Gait Scale) were performed before treatment and 3, 8, and 16 wks posttreatment. RESULTS: Active and passive dorsiflexion and calf tone in both groups and Observational Gait Scale total scores in the distal group improved at all time points. The median change from baseline values in Observational Gait Scale initial foot contact and total scores at 8 wks showed a significant difference favoring the distal group, but the clinical relevance remained tenuous. CONCLUSIONS: Using the methods described, no major changes in main outcome measures were associated with changing the injection site.
Authors: Reggie C Hamdy; Kathleen Montpetit; Joanne Ruck-Gibis; Kelly Thorstad; Ellen Raney; Michael Aiona; Robert Platt; Allen Finley; William Mackenzie; James McCarthy; Unni Narayanan Journal: Trials Date: 2007-09-28 Impact factor: 2.279