Intrathecal delivery of baclofen provided greater efficacy than oral administration of an antispasmodic agent for adult patients with generalized poststroke spasticity, according to findings from a randomized, open-label, phase 4 study published in the Journal of Neurology, Neurosurgery, and Psychiatry.
Investigators compared the therapeutic efficacy of intrathecal baclofen (ITB) vs oral administration of an antispasmodic agent (conventional medical management [CMM]) in 60 adult patients with poststroke spasticity. Participants were randomly assigned to either ITB (n=31) or CMM (n=29) and were assessed at 6 months for change in the average Ashworth Scale score in the lower extremities of the affected body side. All patients had chronic stroke with spasticity in at least 2 extremities, as well as an Ashworth Scale score of at least 3 in at least 2 affected muscle groups in the lower extremities.
In the primary analysis, ITB therapy demonstrated a significantly higher effect than CMM in terms of the average change in Ashworth Scale score (mean score reduction, -0.99 [ITB] vs -0.43 [CMM]; Hodges-Lehmann estimate, -0.667 [95.1% CI: -1.0000 to 0.1667; P =.0140]. There was a significant effect of ITB therapy vs CMM for the modified intention-to-treat (ITT) population (P =.0019) and for patients who completed the trial (P =.0240).
Also, the ITB arm showed a 2.68-point improvement in the Functional Independence Measure score, while the CMM group demonstrated a 2.58-point decrease in the score. Overall, the investigators found a trend toward greater functional improvement in the ITB vs CMM arm (P =.0540). While ITB therapy was associated with greater efficacy, participants randomly assigned to the intrathecal route reported a greater number of adverse events vs patients randomly assigned to CMM (149 vs 77 events, respectively). These events were considered consistent with the previously reported safety profile of ITB.
The small sample size, which was primarily due to recruitment challenges, represents a significant limitation of this study. Additionally, the short 6-month follow-up was not long enough to evaluate long-term functional improvements among each group.
Compared with oral administration of antispasmodic agents, the use of a “continuous infusion also confers prolonged and stable tone control” and appears to provide a greater therapeutic effect for adults with poststroke spasticity.
Creamer M, Cloud G, Kossmehl P, et al. Intrathecal baclofen therapy versus conventional medical management for severe poststroke spasticity: results from a multicentre, randomised, controlled, open-label trial (SISTERS) [published online January 11, 2018]. J Neurol Neurosurg Psychiatry. doi:10.1136/jnnp-2017-317021