Intrathecal Baclofen Therapy Decreases Pain and Improves Quality of Life Compared to Conventional Medical Management in Severe Post-Stroke Spasticity: the SISTERS Study

Michael Yochelson; Michael Creamer; Geoffrey Cloud; Peter Kossemehl; Gerard Francisco; Anthony Ward; Joerg Wissel; Mauro Zampolini; Meghann  Loven; Abdallah Abouihia; Alessandra Calabrese; Leopold Saltuari

doi:10.1212/WNL.90.15_supplement.P5.014

Intrathecal Baclofen Therapy Decreases Pain and Improves Quality of Life Compared to Conventional Medical Management in Severe Post-Stroke Spasticity: the SISTERS Study

Michael Yochelson, Michael Creamer, Geoffrey Cloud, Peter Kossemehl, Gerard Francisco, Anthony Ward, Joerg Wissel, Mauro Zampolini, Meghann Loven, Abdallah Abouihia, Alessandra Calabrese, Leopold Saltuari

Research output: Contribution to journal › Meeting Abstract

Abstract

Objective: Compare muscle tone decrease, pain reduction and quality of life improvement from baseline to month 6 between Intrathecal Baclofen (ITB) therapy versus conventional medical management (CMM) with oral antispastic in the treatment of post-stroke spasticity. Background: SISTERS is the first multicenter randomized controlled trial comparing ITB therapy to CMM in post-stroke spasticity. Design/Methods: Sixty stroke patients with spasticity in ≥2 extremities and an Ashworth Scale (AS)score ≥ 3 in at least 2 affected muscle groups in the lower limbs were randomized to ITB or CMM group. Both groups received physiotherapy. Results: Reduction in average (SD) AS in the affected lower limbs was 0.99 (0.75) in ITB group versus 0.43 (0.72) in CMM patients (P<0.05). Mean AS in upper limb decreased by 0.66 (0.59) versus 0.17 (0.70) in ITB and CMM groups, respectively (P<0.05). Change in Numeric Pain Rating Scale was −1.17 (3.17), −1.61 (2.29) and −1.35 (2.42) in ITB versus 0.00 (3.29),0.24 (3.07) and −0.04 (3.69) in CMM group for actual, least and worst pain, respectively. The change was significant in actual and least pain (P<0.05). Quality of life assessed by EQ-5D utility score improved in ITB patients by 0.09 (0.26) compared to 0.01 (0.16) in CMM group, (P<0.05). EQ-5D health status score increased by 9.68 (20.42) in ITB versus 4.40 (21.75) in the CMM group (P>0.05). In total 17 (68%) ITB implanted patients reported at least one treatment-related adverse events versus 7 (20%) in CMM group. Most frequent drug reactions were muscular weakness (16% of patients), hypotonia (12%), fall (12%) and urinary retention (12%) in implanted patients and somnolence (9%) in CMM group. Conclusions: The study demonstrated superiority of ITB therapy versus conventional oralmedication in decreasing muscle hypertonia in post-stroke patients with spasticity. This also resulted in improvement of pain and quality of life in ITB patients. Study Supported by: Medtronic

Original language	English
Pages (from-to)	P5.014
Number of pages	1
Journal	Neurology
Volume	90
Issue number	15 Supplement
DOIs	https://doi.org/10.1212/WNL.90.15_supplement.P5.014
Publication status	Published - 10 Apr 2018
Externally published	Yes
Event	Annual Meeting of the American Academy of Neurology 2018 - Los Angeles Convention Center, Los Angeles, United States of America Duration: 21 Apr 2018 → 27 Apr 2018 Conference number: 70th https://www.neurology.org/toc/wnl/90/15_supplement

Keywords

Stroke rehabilitation
Intrathecal injection
Baclofen

Access to Document

10.1212/WNL.90.15_supplement.P5.014

Cite this

Yochelson, M., Creamer, M., Cloud, G., Kossemehl, P., Francisco, G., Ward, A., Wissel, J., Zampolini, M., Loven, M., Abouihia, A., Calabrese, A., & Saltuari, L. (2018). Intrathecal Baclofen Therapy Decreases Pain and Improves Quality of Life Compared to Conventional Medical Management in Severe Post-Stroke Spasticity: the SISTERS Study . Neurology, 90(15 Supplement), P5.014. https://doi.org/10.1212/WNL.90.15_supplement.P5.014

@article{7fd25529a7c14253b1cb6af976427b17,

title = "Intrathecal Baclofen Therapy Decreases Pain and Improves Quality of Life Compared to Conventional Medical Management in Severe Post-Stroke Spasticity: the SISTERS Study ",

abstract = " Objective: Compare muscle tone decrease, pain reduction and quality of life improvement from baseline to month 6 between Intrathecal Baclofen (ITB) therapy versus conventional medical management (CMM) with oral antispastic in the treatment of post-stroke spasticity. Background: SISTERS is the first multicenter randomized controlled trial comparing ITB therapy to CMM in post-stroke spasticity. Design/Methods: Sixty stroke patients with spasticity in ≥2 extremities and an Ashworth Scale (AS)score ≥ 3 in at least 2 affected muscle groups in the lower limbs were randomized to ITB or CMM group. Both groups received physiotherapy. Results: Reduction in average (SD) AS in the affected lower limbs was 0.99 (0.75) in ITB group versus 0.43 (0.72) in CMM patients (P<0.05). Mean AS in upper limb decreased by 0.66 (0.59) versus 0.17 (0.70) in ITB and CMM groups, respectively (P<0.05). Change in Numeric Pain Rating Scale was −1.17 (3.17), −1.61 (2.29) and −1.35 (2.42) in ITB versus 0.00 (3.29),0.24 (3.07) and −0.04 (3.69) in CMM group for actual, least and worst pain, respectively. The change was significant in actual and least pain (P<0.05). Quality of life assessed by EQ-5D utility score improved in ITB patients by 0.09 (0.26) compared to 0.01 (0.16) in CMM group, (P<0.05). EQ-5D health status score increased by 9.68 (20.42) in ITB versus 4.40 (21.75) in the CMM group (P>0.05). In total 17 (68\%) ITB implanted patients reported at least one treatment-related adverse events versus 7 (20\%) in CMM group. Most frequent drug reactions were muscular weakness (16\% of patients), hypotonia (12\%), fall (12\%) and urinary retention (12\%) in implanted patients and somnolence (9\%) in CMM group. Conclusions: The study demonstrated superiority of ITB therapy versus conventional oralmedication in decreasing muscle hypertonia in post-stroke patients with spasticity. This also resulted in improvement of pain and quality of life in ITB patients. Study Supported by: Medtronic ",

keywords = "Stroke rehabilitation, Intrathecal injection, Baclofen",

author = "Michael Yochelson and Michael Creamer and Geoffrey Cloud and Peter Kossemehl and Gerard Francisco and Anthony Ward and Joerg Wissel and Mauro Zampolini and Meghann Loven and Abdallah Abouihia and Alessandra Calabrese and Leopold Saltuari",

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day = "10",

doi = "10.1212/WNL.90.15\_supplement.P5.014",

language = "English",

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journal = "Neurology",

issn = "0028-3878",

publisher = "Ovid Technologies (Wolters Kluwer) - American Academy of Neurology",

number = "15 Supplement",

note = "Annual Meeting of the American Academy of Neurology 2018, AAN 2018 ; Conference date: 21-04-2018 Through 27-04-2018",

url = "https://www.neurology.org/toc/wnl/90/15\_supplement",

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Yochelson, M, Creamer, M, Cloud, G, Kossemehl, P, Francisco, G, Ward, A, Wissel, J, Zampolini, M, Loven, M, Abouihia, A, Calabrese, A & Saltuari, L 2018, 'Intrathecal Baclofen Therapy Decreases Pain and Improves Quality of Life Compared to Conventional Medical Management in Severe Post-Stroke Spasticity: the SISTERS Study ', Neurology, vol. 90, no. 15 Supplement, pp. P5.014. https://doi.org/10.1212/WNL.90.15_supplement.P5.014

TY - JOUR

T1 - Intrathecal Baclofen Therapy Decreases Pain and Improves Quality of Life Compared to Conventional Medical Management in Severe Post-Stroke Spasticity

T2 - Annual Meeting of the American Academy of Neurology 2018

AU - Yochelson, Michael

AU - Creamer, Michael

AU - Cloud, Geoffrey

AU - Kossemehl, Peter

AU - Francisco, Gerard

AU - Ward, Anthony

AU - Wissel, Joerg

AU - Zampolini, Mauro

AU - Loven, Meghann

AU - Abouihia, Abdallah

AU - Calabrese, Alessandra

AU - Saltuari, Leopold

N1 - Conference code: 70th

PY - 2018/4/10

Y1 - 2018/4/10

N2 - Objective: Compare muscle tone decrease, pain reduction and quality of life improvement from baseline to month 6 between Intrathecal Baclofen (ITB) therapy versus conventional medical management (CMM) with oral antispastic in the treatment of post-stroke spasticity. Background: SISTERS is the first multicenter randomized controlled trial comparing ITB therapy to CMM in post-stroke spasticity. Design/Methods: Sixty stroke patients with spasticity in ≥2 extremities and an Ashworth Scale (AS)score ≥ 3 in at least 2 affected muscle groups in the lower limbs were randomized to ITB or CMM group. Both groups received physiotherapy. Results: Reduction in average (SD) AS in the affected lower limbs was 0.99 (0.75) in ITB group versus 0.43 (0.72) in CMM patients (P<0.05). Mean AS in upper limb decreased by 0.66 (0.59) versus 0.17 (0.70) in ITB and CMM groups, respectively (P<0.05). Change in Numeric Pain Rating Scale was −1.17 (3.17), −1.61 (2.29) and −1.35 (2.42) in ITB versus 0.00 (3.29),0.24 (3.07) and −0.04 (3.69) in CMM group for actual, least and worst pain, respectively. The change was significant in actual and least pain (P<0.05). Quality of life assessed by EQ-5D utility score improved in ITB patients by 0.09 (0.26) compared to 0.01 (0.16) in CMM group, (P<0.05). EQ-5D health status score increased by 9.68 (20.42) in ITB versus 4.40 (21.75) in the CMM group (P>0.05). In total 17 (68%) ITB implanted patients reported at least one treatment-related adverse events versus 7 (20%) in CMM group. Most frequent drug reactions were muscular weakness (16% of patients), hypotonia (12%), fall (12%) and urinary retention (12%) in implanted patients and somnolence (9%) in CMM group. Conclusions: The study demonstrated superiority of ITB therapy versus conventional oralmedication in decreasing muscle hypertonia in post-stroke patients with spasticity. This also resulted in improvement of pain and quality of life in ITB patients. Study Supported by: Medtronic

AB - Objective: Compare muscle tone decrease, pain reduction and quality of life improvement from baseline to month 6 between Intrathecal Baclofen (ITB) therapy versus conventional medical management (CMM) with oral antispastic in the treatment of post-stroke spasticity. Background: SISTERS is the first multicenter randomized controlled trial comparing ITB therapy to CMM in post-stroke spasticity. Design/Methods: Sixty stroke patients with spasticity in ≥2 extremities and an Ashworth Scale (AS)score ≥ 3 in at least 2 affected muscle groups in the lower limbs were randomized to ITB or CMM group. Both groups received physiotherapy. Results: Reduction in average (SD) AS in the affected lower limbs was 0.99 (0.75) in ITB group versus 0.43 (0.72) in CMM patients (P<0.05). Mean AS in upper limb decreased by 0.66 (0.59) versus 0.17 (0.70) in ITB and CMM groups, respectively (P<0.05). Change in Numeric Pain Rating Scale was −1.17 (3.17), −1.61 (2.29) and −1.35 (2.42) in ITB versus 0.00 (3.29),0.24 (3.07) and −0.04 (3.69) in CMM group for actual, least and worst pain, respectively. The change was significant in actual and least pain (P<0.05). Quality of life assessed by EQ-5D utility score improved in ITB patients by 0.09 (0.26) compared to 0.01 (0.16) in CMM group, (P<0.05). EQ-5D health status score increased by 9.68 (20.42) in ITB versus 4.40 (21.75) in the CMM group (P>0.05). In total 17 (68%) ITB implanted patients reported at least one treatment-related adverse events versus 7 (20%) in CMM group. Most frequent drug reactions were muscular weakness (16% of patients), hypotonia (12%), fall (12%) and urinary retention (12%) in implanted patients and somnolence (9%) in CMM group. Conclusions: The study demonstrated superiority of ITB therapy versus conventional oralmedication in decreasing muscle hypertonia in post-stroke patients with spasticity. This also resulted in improvement of pain and quality of life in ITB patients. Study Supported by: Medtronic

KW - Stroke rehabilitation

KW - Intrathecal injection

KW - Baclofen

U2 - 10.1212/WNL.90.15_supplement.P5.014

DO - 10.1212/WNL.90.15_supplement.P5.014

M3 - Meeting Abstract

SN - 0028-3878

VL - 90

SP - P5.014

JO - Neurology

JF - Neurology

IS - 15 Supplement

Y2 - 21 April 2018 through 27 April 2018

ER -