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)

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). 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 Disclosure: Dr. Yochelson has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Best Doctors. Dr. Yochelson has received research support from Helius Medical Technologies, payment to MedStar National Rehabilitation Network, as I was PI for clinical trail. Dr. Creamer has nothing to disclose. Dr. Cloud has nothing to disclose. Dr. Kossmehl has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Merz Pharmaceuticals GmbH, ASKLEPIOS Fachklinikum Teupitz. Dr. Francisco has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan, Ipsen, Merz, Medtronic. Dr. Francisco has received personal compensation in an editorial capacity for Journal of Rehabilitation Medicine. Dr. Francisco has received research support from Allergan, Ipsen, Merz, Medtronic, Microtransponder, Ottobock. Dr. Ward has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan, Ipsen. Dr. Wissel has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan, Ipsen, Medtronic, Merz. Dr. Zampolini has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Medtronic. Dr. Loven has nothing to disclose. Dr. Abouihia has nothing to disclose. Dr. Calabrese has nothing to disclose. Dr. Saltuari has nothing to disclose.