57. The UK&I National Neuromodulation Registry: intrathecal baclofen improves patient perception of spasticity but does not improve quality of life

Abstract

Background: Intrathecal baclofen (ITB) is a well-established treatment for refractory spasticity. Its clinical effect in relieving the symptoms of spasticity is well recognised, but whether or not this translates into a change in health-related quality of life (QoL) is more contentious. We examine patients from the National Neuromodulation Registry (NNR) that were implanted with an intrathecal baclofen delivery device for spasticity. Method(s): QoL data (EuroQoL 5 level, EQ5D and global impression of change), the numeric rating scale for spasticity score (NRS), and demographic data were extracted from NNR for all patients that underwent ITB for refractory spasticity between February 2018 and July 2024. Patients were followed up at 6 and 12 months post implant. Result(s): There were 257 patients registered. The mean age at implantation was 47.5 years (sd 14.1 years, range 16-85 years, n=100). The sex ratio was balanced with 134F:123M. The mean daily dosage of baclofen at implantation was 351mug/24h (range 23-6387mug/24h, n=166). The median EQ5D utility index was -0.015 (IQR=0.229, n=162) pre-operatively, while at 6 months post-operation it was 0.011 (IQR=0.178, n=22), p=0.52, Wilcoxon rank sum test. The median utility score at 12 months post-operation was -0.072 (IQR=0.217, n=23). There was no difference in utility scores at 6 months and 12 months after implantation (p=0.31, Wilcoxon rank sum test). In the patients that had paired pre- and post-operative EQ5D indices (n=24), the mean change in utility was -0.008 (sd 0.212). Of 257 patients, only 67 had a pre-operative NRS for spasticity recorded (mean=6.2, sd=2.8). Of those 67 only 10 had an either 6- or 12-month score recorded. The mean score before surgery was 7.9 (sd=1.9), and after surgery was 5.4 (sd=3.1) - this improvement was not significant (p=0.08, paired Student's t-test). Of the 25 patients that reported a global impression of change score, 76% reported an improvement in their clinical condition 6 months after surgery, and this was maintained at 12 months. Conclusion(s): Intrathecal baclofen therapy does not improve health-related QoL when measured using the EQ5D-5L tool - this is in agreement with previous studies, however patients' experience seems to be that overall there is an improvement in their condition. Some other studies have shown an improvement using disease specific QoL tools, and these may be more useful when reporting this important patient-reported outcome measure in this patient population. Completeness of data in the National Registry is poor, and this needs to be addressed for useful conclusions to be drawn using this potentially powerful tool. Copyright © 2025