Intrathecal baclofen management of poststroke spastic hypertonia: Implications for function and quality of life

Objectives: To evaluate the impact of intrathecal baclofen (ITB) on function and quality of life (QOL) and to obtain efficacy and safety data in poststroke spastic hypertonia. Design: Prospective open-label multicenter trial with follow-up at 3 and 12 months. Setting: Twenty-four stroke treatment centers in the United States. Participants: Ninety-four stroke participants (age range, 24-82y) with spastic hypertonia. Seventy-four participants underwent ITB pump implantation. Intervention: Participants were implanted with an ITB pump. Main Outcome Measures: FIM instrument and QOL (Sickness Impact Profile [SIP]) changes, spastic hypertonia (Ashworth Scale), and safety. Results: FIM scores improved overall in repeated-measures analysis of variance (ANOVA) (P=.005) and by 3.00 +/- 7.69 (P=.001) at 3 months and by 2.86 +/- 10.13 (P=.017) at 12 months. Significant improvements in SIP scores were noted overall (repeated-measures ANOVA, P<.001) and at 3 (P=.003) and 12 months (P<.001). The combined average Ashworth Scale score of the upper and lower limbs decreased by 1.27 +/- 0.76 (P<.001) at 3 months and by 1.39 +/- 0.73 (P<.001) at 12 months from baseline, which was significant overall (repeated-measures ANOVA, P<.001). Strength in the unaffected side did not change overall (repeated-measures ANOVA, P=.321) or at either 3 (P=.553) or 12 months (P=.462). Minimal adverse events and device complications were reported. Conclusions: There was significant improvement in function, QOL, and spastic hypertonia at 3 and 12 months after implant, without adversely affecting muscle strength of the unaffected limbs. Data suggest that ITB therapy is a safe and efficacious treatment for spastic hypertonia resulting from stroke.