Clinical Experience With Continuous Intrathecal Baclofen Trials Prior to Pump Implantation.

OBJECTIVE: To report our clinical experience using continuous intrathecal baclofen (ITB) trials prior to permanent pump implantation.

DESIGN: Retrospective chart review.

SETTING: An inpatient neurosurgery unit and outpatient physical medicine and rehabilitation clinics.

PARTICIPANTS: Fifty-seven patients with refractory spasticity who underwent a continuous ITB trial during the years 2006-2012.

METHODS: Patients underwent placement of a temporary intrathecal catheter that was connected to an external pump. A successful trial was defined as a one-level reduction in lower limb modified Ashworth scores in key spastic lower limb muscles identified for each individual patient. Subjective improvement in function or ease of performing functional tasks also were monitored.

MAIN OUTCOME MEASURES: Modified Ashworth scores, functional mobility in ambulatory patients only, and the incidence and severity of adverse events during the trial and up to 1 year after implantation.

RESULTS: Spasticity significantly decreased during the trial. Average ambulation distance was unchanged, although 34% of ambulatory patients progressed to a less restrictive assistive device by trial completion. Adverse events (AEs) occurred in 26 patients. Minor AEs were seen in 18 patients, with the most common being nausea, transient urinary retention, and headache. Pumps were implanted in 86% of patients; 14% did not receive a pump because of AEs or because goals were not met. Six patients had their pump removed at 12 months for the following reasons: pump malfunctions (3), skin breakdown around the pump (1), infection (1), and expectations not met (1).

CONCLUSIONS: Continuous trials via an external catheter could be an option if patients and clinicians desire a comprehensive assessment of systemic and functional effects of ITB before pump implantation. The majority of AEs were minor and resolved spontaneously, and the most effective starting intrathecal dose was determined by pump insertion.