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Intrathecal baclofen therapy versus conventional medical management for severe poststroke spasticity: results from a multicentre, randomised, controlled, open-label trial (SISTERS).
J Neurol Neurosurg Psychiatry. 2018 06; 89(6):642-650.JN

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.

Authors+Show Affiliations

Central Florida Pain Relief Centers, Orlando, Florida, USA.St. George's University Hospitals NHS Foundation Trust, London, UK. Department of Neurology, Alfred Health, Melbourne, Victoria, Australia.Kliniken Beelitz GmbH Neurologische Rehabilitationsklinik, Beelitz-Heilstätten, Germany.MedStar National Rehabilitation Hospital, Washington DC, USA. Shepherd Center, Atlanta, Georgia, USA.Department of Physical Medicine and Rehabilitation, University of Texas Health Science Center, Houston, Texas, USA. TIRR Memorial Hermann Hospital, Houston, Texas, USA.North Staffordshire Rehabilitation Centre, Haywood Hospital, Stoke on Trent, UK.Department of Neurology, Neurological Rehabilitation and Physical Therapy, Vivantes Hospital Spandau, Berlin, Germany.Department of Rehabilitation, Ospedale di Foligno, USL Umbria 2, Perugia, Italy.Neuromodulation Clinical, Medtronic International Trading Sarl, Tolochenaz, Switzerland.Neuromodulation Clinical, Medtronic International Trading Sarl, Tolochenaz, Switzerland.Neuromodulation Clinical, Medtronic International Trading Sarl, Tolochenaz, Switzerland.Medtronic Inc, Minneapolis, Minnesota, USA.Abteilung für Neurologie, Landeskrankenhaus Hochzirl, Zirl, Austria. Research Unit for Neurorehabilitation, South Tyrol, Bolzano, Italy.

Pub Type(s)

Clinical Trial, Phase IV
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

29326296

Citation

Creamer, Michael, et al. "Intrathecal Baclofen Therapy Versus Conventional Medical Management for Severe Poststroke Spasticity: Results From a Multicentre, Randomised, Controlled, Open-label Trial (SISTERS)." Journal of Neurology, Neurosurgery, and Psychiatry, vol. 89, no. 6, 2018, pp. 642-650.
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). J Neurol Neurosurg Psychiatry. 2018;89(6):642-650.
Creamer, M., Cloud, G., Kossmehl, P., Yochelson, M., Francisco, G. E., Ward, A. B., Wissel, J., Zampolini, M., Abouihia, A., Berthuy, N., Calabrese, A., Loven, M., & Saltuari, L. (2018). Intrathecal baclofen therapy versus conventional medical management for severe poststroke spasticity: results from a multicentre, randomised, controlled, open-label trial (SISTERS). Journal of Neurology, Neurosurgery, and Psychiatry, 89(6), 642-650. https://doi.org/10.1136/jnnp-2017-317021
Creamer M, et al. Intrathecal Baclofen Therapy Versus Conventional Medical Management for Severe Poststroke Spasticity: Results From a Multicentre, Randomised, Controlled, Open-label Trial (SISTERS). J Neurol Neurosurg Psychiatry. 2018;89(6):642-650. PubMed PMID: 29326296.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Intrathecal baclofen therapy versus conventional medical management for severe poststroke spasticity: results from a multicentre, randomised, controlled, open-label trial (SISTERS). AU - Creamer,Michael, AU - Cloud,Geoffrey, AU - Kossmehl,Peter, AU - Yochelson,Michael, AU - Francisco,Gerard E, AU - Ward,Anthony B, AU - Wissel,Jörg, AU - Zampolini,Mauro, AU - Abouihia,Abdallah, AU - Berthuy,Nathalie, AU - Calabrese,Alessandra, AU - Loven,Meghann, AU - Saltuari,Leopold, Y1 - 2018/01/11/ PY - 2017/08/04/received PY - 2017/11/13/revised PY - 2017/12/05/accepted PY - 2018/1/13/pubmed PY - 2019/10/8/medline PY - 2018/1/13/entrez SP - 642 EP - 650 JF - Journal of neurology, neurosurgery, and psychiatry JO - J Neurol Neurosurg Psychiatry VL - 89 IS - 6 N2 - 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. SN - 1468-330X UR - https://www.unboundmedicine.com/medline/citation/29326296/Intrathecal_baclofen_therapy_versus_conventional_medical_management_for_severe_poststroke_spasticity:_results_from_a_multicentre_randomised_controlled_open_label_trial__SISTERS__ L2 - https://jnnp.bmj.com/lookup/pmidlookup?view=long&pmid=29326296 DB - PRIME DP - Unbound Medicine ER -