RT Journal Article
SR Electronic
T1 Intrathecal baclofen therapy versus conventional medical management for severe poststroke spasticity: results from a multicentre, randomised, controlled, open-label trial (SISTERS)
JF Journal of Neurology, Neurosurgery & Psychiatry
JO J Neurol Neurosurg Psychiatry
FD BMJ Publishing Group Ltd
SP jnnp-2017-317021
DO 10.1136/jnnp-2017-317021
A1 Michael Creamer
A1 Geoffrey Cloud
A1 Peter Kossmehl
A1 Michael Yochelson
A1 Gerard E Francisco
A1 Anthony B Ward
A1 Jörg Wissel
A1 Mauro Zampolini
A1 Abdallah Abouihia
A1 Nathalie Berthuy
A1 Alessandra Calabrese
A1 Meghann Loven
A1 Leopold Saltuari
YR 2018
UL http://jnnp.bmj.com/content/early/2018/03/08/jnnp-2017-317021.abstract
AB Background Intrathecal baclofen (ITB) is a treatment option for patients with severe poststroke spasticity (PSS) who have not reached their therapy goal with other interventions.Methods ’Spasticity In Stroke–Randomised Study' (SISTERS) was a randomised, controlled, open-label, multicentre phase IV study to evaluate the efficacy and safety of ITB therapy versus conventional medical management (CMM) with oral antispastic medications for treatment of PSS. Patients with chronic stroke with spasticity in ≥2 extremities and an Ashworth Scale (AS) score ≥3 in at least two affected muscle groups in the lower extremities (LE) were randomised (1:1) to ITB or CMM. Both treatment arms received physiotherapy throughout. The primary outcome was the change in the average AS score in the LE of the affected body side from baseline to month 6. Analyses were performed for all patients as randomised (primary analysis) and all randomised patients as treated (safety analysis).Results Of 60 patients randomised to ITB (n=31) or CMM (n=29), 48 patients (24 per arm) completed the study. The primary analysis showed a significant effect of ITB therapy over CMM (mean AS score reduction, −0.99 (ITB) vs −0.43 (CMM); Hodges-Lehmann estimate, −0.667(95.1%CI −1.0000 to −0.1667); P=0.0140). More patients reported adverse events while receiving ITB (24/25 patients, 96%; 149 events) compared with CMM (22/35, 63%; 77 events), although events were generally consistent with the known safety profile of ITB therapy.Conclusions These data support the use of ITB therapy as an alternative to CMM for treatment of generalised PSS in adults.Trial registration number NCT01032239; Results.