Spasticity-related pain in children/adolescents with cerebral palsy. Part 2: IncobotulinumtoxinA efficacy results from a pooled analysis.
Michaela Bonfert, Florian Heinen, Petr Kaňovský and 8 others
PMID 36057802WHAT IT FOUND
Children with cerebral palsy reported less spasticity-related pain after incobotulinumtoxinA injections, with relief deepening over four cycles.
By the fourth cycle, 33.8% were pain-free during hard tasks. Without a placebo group, some improvement may reflect natural variation rather than the drug alone.
Key findings
01The proportion of children reporting lower limb spasticity-related pain dropped from 81.9% at baseline to 68.3% after the first injection cycle and 54.9% after the fourth.
02After four injection cycles, 33.8% of children with lower limb spasticity and 48.4% with upper limb spasticity reported complete pain relief during self-defined hard tasks.
03The analysis pooled data from randomized and open-label studies without a placebo control group, citing ethical concerns for this pediatric population.
STILL TO COME
How it was doneWhat they foundWhat it means for PTsWhat it means for OTs
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What it does not show
No placebo or control group was included, so improvements cannot be definitively attributed to incobotulinumtoxinA rather than natural course or regression to the mean. Data were pooled from three studies with different designs, durations, and dosing regimens, which may introduce heterogeneity. Children who provided questionnaire data tended to be older and less severely disabled than the overall study population, limiting generalizability to younger or more impaired patients. The QPS was not the primary outcome of the original trials, and pain relief was assessed retrospectively in a secondary analysis. Other pain sources in cerebral palsy were not fully excluded, though the QPS was designed to isolate spasticity-related pain.
Declared interests
The study was supported by Merz Pharmaceuticals GmbH, the manufacturer of incobotulinumtoxinA. The publication types note non-U.S. government support.
The easy way to misread this
Do not assume the pain relief was proven superior to no treatment or placebo. The studies lacked a control group, and the analysis was secondary to the primary spasticity outcomes, so the observed improvements may not be solely due to incobotulinumtoxinA.