Fifteen years of intrathecal baclofen therapy in China: complications, safety governance, and a multimodal neuromodulation strategy.

Abstract

To share real-world experiences and insights regarding complications associated with intrathecal baclofen (ITB) therapy from a major Chinese tertiary center, providing practical guidance for regions where ITB use is still emerging. A single-center, single-surgeon retrospective analysis was conducted on all patients who received ITB pump implantation at Ruijin Hospital (Shanghai, China) between 1st Jan 2011, and 31st Oct 2025. Data on demographics, medical history, and ITB-associated complications were extracted. Clinical effectiveness was assessed using a 5-level Likert scale of goal achievement. Data from 68 individuals (44 males), representing 214.3 pump-years of therapy, were included. The most common supra-spinal pathology was cerebral palsy (10/68, 14.7%), and the predominant spinal pathology was traumatic spinal cord injury (23/68, 33.8%). 87.2% of individuals reported to have goals considered achieved or partially achieved. A total of 24 complications were documented in 19 individuals. The overall complication incidence was 0.11 events per pump-year and 0.30 per implantation. Catheter-related issues were the most frequent (8/24, 33.3%), followed by drug-related (7/24, 29.2%) and procedure-related (6/24, 25.0%) complications. Human error-related issues accounted for 25.0% (6/24) of all documented complications. Notably, refinement of surgical nuances was found to successfully mitigate wound tension and skin erosion. In addition, a multimodal neuromodulation strategy integrating sacral neuromodulation was successfully piloted in a representative case of ITB dose-limiting urinary retention. This study presents one of the largest reported ITB cohort in China. Our experiences underscore that long-term success in ITB therapy extends beyond surgical precision to encompass systemic clinical governance, including rigorous safety protocols and the management of refractory side effects through multimodal neuromodulation approaches. These insights, including the novel use of multimodal neuromodulation to manage dose-limiting adverse effects of ITB, may help optimize ITB practice, particularly in regions where its use is still emerging.