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The problem
Intervention: Ethanol neurolysis combined with onabotulinumtoxinA injections, using ultrasound guidance and electrical stimulation, compared to onabotulinumtoxinA injections alone
Who it was tested with: 167 children with cerebral palsy (112 in onabotulinumtoxinA-only group, 55 in combined group) not undergoing other treatments during the injection period.
The same group is measured before the intervention and again afterwards, with a baseline and an endline and sometimes a midline. Change is visible, but other causes cannot be ruled out.
"A post-procedure evaluation at 2 weeks after injection documented any adverse effects experienced by the child and perceived magnitude of improvement using an ordinal scale from 1 to 5. Multiple linear regression was used to identify and control for covariates including Gross Motor Function Classification System, gender, age, weight, ethnicity, race, and dosage." This is a pre-post cohort comparison with standardised outcome measurement and statistical control for confounders, but lacks a randomised design and uses subjective outcome measures.
Prospective cohort design without randomisation means groups may differ in unmeasured ways; outcome measured by parent/caregiver perception rather than objective clinical assessment; relatively short follow-up of 2 weeks
Across countries and designs
1 study · 1 country