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

Introduction/Background 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. Material and method 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. Results 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 Conclusion Reduction of muscle tone with ITB therapy is associated with improvements in pain and QoL in post-stroke patients with severe spasticity.