Intrathecal Baclofen Trial Before Device Implantation: 12-Year Experience With Continuous Administration

Abstract Objective To report our experience using continuous intrathecal baclofen (ITB) administration prior to a possible ITB device implantation. Design Retrospective open label study. Mean duration of follow-up 64 months. Setting Primary-care and referral center, ambulatory and hospitalized care. Participants Patients (N=116) undergoing continuous ITB trials between 2006 and 2017. Interventions Continuous application of baclofen via a temporary intrathecal catheter connected to an external pump. Main Outcome Measures Assessment of the modified Ashworth Scale and range of movement prior versus end of ITB trial. According to the Barthel Index, definition of high-level patients (60-100 scoring points) and low-level patients (0-55 scoring points). Calculation of the Rivermead Mobility Index in high-level patients prior versus end of ITB trial. Evaluation of occurring adverse events. Results A total of 119 ITB trials were performed in 116 patients (78 men, mean age 41±16), 113 patients completed the trials (31 of 113 high level, 82 of 113 low level). The median modified Ashworth scale improved from 4 (interquartile range [IQR] 3-4) to 2 (IQR 1-2; P ≤.001), the range of movement from 2 (IQR 1-3) to 3 (IQR 3-3; P ≤.001). The Rivermead Mobility Index increased from 9 (IQR 6-12) to 10 (IQR 7-12.5; P =.004) in high-level patients. Eighty-eight out of 113 patients (78%) were appropriate candidates for ITB device surgery, 75 of 88 (85%) proceeded to an implantation. A total of 69 adverse events occurred in 57 of 119 trials (48%), 37 of 69 (54%) were drug related, 32 of 69 (46%) were procedure related, and 42 of 69 (61%) were minor. The ITB device was implanted in 69 of 75 patients (92%) at last follow-up. Conclusions Continuous administration of ITB is an effective and useful alternative to ITB bolus application during ITB screening period. Half of the patients experienced adverse events; the majority were minor events.