Intrathecal baclofen therapy versus conventional medical management in post-stroke spasticity: Assessment of patient-reported outcome: Quality of life, pain and satisfaction (SISTERS)

Abstract

SISTERS is the first multicenter randomized trial demonstrating superiority of intrathecal baclofen (ITB) therapy versus conventional medical management (CMM) with oral antispastic in decreasing muscle hypertonia in lower and upper limbs of post-stroke patients with severe spasticity. Here we report Numeric Pain Rating Scale (NPRS), Quality of Life (QoL) assessed by EQ-5D and Stroke Specific QoL (SS-QoL), satisfaction and safety. Sixty stroke patients with spasticity in ≥ 2 extremities and an Ashworth Scale score ≥ 3 in ≥ 2 affected muscle groups in the lower limbs were randomized to ITB or CMM group and both arms received physiotherapy. Mean changes (SD) from baseline to month 6 in ITB patients versus CMM group were −1.17 (3.17) vs. 0.00 (3.29) for NPRS actual pain, −1.61 (2.29) vs. 0.24 (3.07) for NPRS least pain and 0.09 (0.26) vs. 0.01 (0.16) for EQ-5D utility score. These between-group differences were statistically significant ( P < 0.05, Wilcoxon test). ITB patients showed greater improvements in NPRS worst pain [−1.35 (2.42) vs. −0.04 (3.69)], EQ-5D health status [9.68 (20.42) vs. 4.40 (21.75)] and SS-QoL [0.26 (0.58) vs. 0.05 (0.58)], although between-group differences were not statistically significant. Extreme problems of individual EQ-5D dimensions at baseline were reported by 30%, 26%, 17% and 13% of ITB patients in self-care, usual activities, pain/discomfort and mobility, respectively. At 6 months there was a decrease in the percentage of patients reporting extreme problems for all domains except mobility. More ITB than CMM patients (73% vs. 48%) were satisfied with the spasticity reduction at month 6. In total 17 (68%) ITB implanted patients reported at least one treatment-related adverse events versus 7 (20%) in CMM group. No treatment-related adverse event led to discontinuation of ITB therapy. Reduction of muscle tone with ITB therapy is associated with improvements in pain and QoL in post-stroke patients with severe spasticity.