You are here

  • Home
  • Archive
  • Volume 89, Issue 6
  • Intrathecal baclofen therapy versus conventional medical management for severe poststroke spasticity: results from a multicentre, randomised, controlled, open-label trial (SISTERS)

Article Text

Article menu

Download PDFPDF

Cerebrovascular disease
Research paper
Intrathecal baclofen therapy versus conventional medical management for severe poststroke spasticity: results from a multicentre, randomised, controlled, open-label trial (SISTERS)
  1. Michael Creamer1,
  2. Geoffrey Cloud2,3,
  3. Peter Kossmehl4,
  4. Michael Yochelson5,6,
  5. Gerard E Francisco7,8,
  6. Anthony B Ward9,
  7. Jörg Wissel10,
  8. Mauro Zampolini11,
  9. Abdallah Abouihia12,
  10. Nathalie Berthuy12,
  11. Alessandra Calabrese12,
  12. Meghann Loven13,
  13. Leopold Saltuari14,15
  1. 1 Central Florida Pain Relief Centers, Orlando, Florida, USA
  2. 2 St. George’s University Hospitals NHS Foundation Trust, London, UK
  3. 3 Department of Neurology, Alfred Health, Melbourne, Victoria, Australia
  4. 4 Kliniken Beelitz GmbH Neurologische Rehabilitationsklinik, Beelitz-Heilstätten, Germany
  5. 5 MedStar National Rehabilitation Hospital, Washington DC, USA
  6. 6 Shepherd Center, Atlanta, Georgia, USA
  7. 7 Department of Physical Medicine and Rehabilitation, University of Texas Health Science Center, Houston, Texas, USA
  8. 8 TIRR Memorial Hermann Hospital, Houston, Texas, USA
  9. 9 North Staffordshire Rehabilitation Centre, Haywood Hospital, Stoke on Trent, UK
  10. 10 Department of Neurology, Neurological Rehabilitation and Physical Therapy, Vivantes Hospital Spandau, Berlin, Germany
  11. 11 Department of Rehabilitation, Ospedale di Foligno, USL Umbria 2, Perugia, Italy
  12. 12 Neuromodulation Clinical, Medtronic International Trading Sarl, Tolochenaz, Switzerland
  13. 13 Medtronic Inc, Minneapolis, Minnesota, USA
  14. 14 Abteilung für Neurologie, Landeskrankenhaus Hochzirl, Zirl, Austria
  15. 15 Research Unit for Neurorehabilitation, South Tyrol, Bolzano, Italy
  1. Correspondence to Dr Michael Creamer, Central Florida Pain Relief Centers, Orlando, Florida, USA; mcreamer{at}surgerypartners.com

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.

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/jnnp-2017-317021

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    View Full Text

    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.