Article Text
Abstract
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.
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Footnotes
Contributors MC: contributed to acquisition of the data and drafted the manuscript for content. GC, PK, MY, GEF, JW and LP: contributed to acquisition of the data. GEF, ABW, JW and MZ: responsible for the study concept and interpretation of the data. LS: was responsible for study concept, coordination of the study and interpretation of the data. AA: designed the study with the Steering Committee and study manager and was the study statistician, providing advice and input on all statistical analyses. NB, ML and AC: responsible for management of the study and interpretation of the data. All authors: contributed to writing and editing of the manuscript and approved the final version.
Funding This work was supported by Medtronic International Trading Sàrl. MC, MZ and LS report personal fees from Medtronic during the conduct of the study. GEF reports grants from Allergan, Ipsen, Merz and Mallinckrodt during the conduct of the study. JW reports personal fees from Medtronic during the conduct of the study, and personal fees from Allergan, Merz, Ipsen, and Medtronic outside the submitted work. AA, NB, AC and ML are all employees of Medtronic and report personal fees from Medtronic during the conduct of the study.
Disclaimer The funder (Medtronic International Trading Sàrl) had a role in the study design, as well as the collection, analysis and interpretation of data, and writing of the report.
Competing interests MC, MZ and LS report personal fees from Medtronic during the conduct of the study. GF reports grants from Allergan, Ipsen, Merz and Mallinckrodt during the conduct of the study. JW reports personal fees from Medtronic during the conduct of the study, and personal fees from Allergan, Merz, Ipsen, and Medtronic outside the submitted work. AA, NB, AC and ML are all employees of Medtronic and report personal fees from Medtronic during the conduct of the study. All other authors declare no competing interests.
Ethics approval An IRB or EC and competent authorities (EU only) approved the study at each participating centre and country.
Provenance and peer review Not commissioned; externally peer reviewed.
Correction notice Since this paper was first published online figure 1 has been updated.