Efficacy of intrathecal baclofen therapy in children with intractable spastic cerebral palsy: a randomised controlled trial.

BACKGROUND: Intractable spasticity can be treated effectively with continuous infusion of intrathecal baclofen. Because evidence for its use in the treatment of children with spastic cerebral palsy is lacking, we conducted a randomised controlled trial.

AIMS: To test whether continuous infusion of intrathecal baclofen is effective in comparison with standard treatment only.

METHODS: Seventeen children, aged 13.2 (SD 2.8) years, with intractable spastic cerebral palsy were randomised to receive a Synchromed pump for continuous infusion of intrathecal baclofen after either 1 month (CITB group) or 6 months (Control group). Primary outcomes were the 6-month-change scores on the 0-10 visual analogue scale for individually formulated problems and the caregiver assistance scale of the Pediatric Evaluation of Disability Inventory self-care domain. One of the secondary outcome measures was health related quality of life as measured with the Child Health Questionnaire-PF50.

RESULTS: Nine children were randomly assigned to the CITB group and eight to the Control group. The visual analogue scale for individual problems improved with 4.0 (SD 1.7) in the CITB group and changed with -0.2 (SD 1.3) in the Control group (p=0.001). Pediatric Evaluation of Disability Inventory scores did not change significantly. The Child Health Questionnaire-PF50 6-month-change score significantly differed in favour of the CITB group for the domains of bodily pain/discomfort (p=0.014), mental health (p=0.045), psychosocial status (p=0.027) and parents' personal time limitation (p=0.043).

CONCLUSION: The results of this randomised controlled trial establish continuous infusion of intrathecal baclofen to be effective in carefully selected children with problems caused by intractable spastic cerebral palsy.