Intrathecal Baclofen Therapy Decreases Pain and Improves Quality of Life Compared to Conventional Medical Management in Severe Post-Stroke Spasticity: the SISTERS Study (P5.014)

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

Research output: Contribution to conferenceAbstract

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 languageEnglish
Publication statusPublished - 10 Apr 2018
EventAnnual Meeting of the American Academy of Neurology - Los Angeles Convention Center, Los Angeles, United States of America
Duration: 21 Apr 201827 Apr 2018
Conference number: 70th

Conference

ConferenceAnnual Meeting of the American Academy of Neurology
Abbreviated titleAAN Annual Meeting
CountryUnited States of America
CityLos Angeles
Period21/04/1827/04/18

Keywords

  • Stroke rehabilitation
  • Intrathecal injection
  • Baclofen

Cite this

Cloud, G., Yochelson, M., Creamer, M., Kossemehl, P., Francisco, G., Ward, A., Wissel, J., Zampolini, M., Saltuari, L., Abouihia, A., & Calabrese, A. (2018). Intrathecal Baclofen Therapy Decreases Pain and Improves Quality of Life Compared to Conventional Medical Management in Severe Post-Stroke Spasticity: the SISTERS Study (P5.014). Abstract from Annual Meeting of the American Academy of Neurology, Los Angeles, United States of America.