CHRONIC INTRATHECAL DELIVERY OF BACLOFEN BY A PROGRAMMABLE PUMP FOR THE TREATMENT OF SEVERE SPASTICITY

The aim of this study was to determine the efficacy, safety, and cost- effectiveness of intrathecal baclofen delivered by a programmable pump for the chronic treatment of severe spasticity. Sixty-six patients wi th severe spasticity of spinal cord origin that was refractory to oral baclofen or who experienced intolerable side effects with this form o f the drug were screened. The first nine participated in a double-blin ded, randomized, placebo (normal saline)-controlled trial to determine response to a bolus dose of intrathecal baclofen. Subsequent patients were enrolled in an open-label treatment protocol without a placebo t rial. All passed the screening, and the pump was implanted in 59 patie nts. Spasticity scores and medical costs before and after surgery were analyzed.In all patients, the mean Ashworth score for rigidity decrea sed from 4.3 preoperatively to 1.4 (p < 0.0005) with use of intratheca l baclofen. The spasm frequency score decreased from a mean of 3.6 to 0.5 (p < 0.0005). Activities of daily living, sleep, and skin integrit y improved, and pain was eradicated in some. Constipation occurred in six patients. A reduction in dosage was necessitated by muscular hypot onia in three ambulatory patients, areflexic bladder and urinary reten tion in three others, and nausea, dizziness, and drowsiness in one. Ca theter-related problems occurred 19 times in 15 patients. One pump was explanted because of infection in the pump pocket, and one was remove d after it eroded through the skin. There were no pump failures. The u se of intrathecal baclofen resulted in a decrease in the average lengt h of subsequent hospitalizations. It is concluded that intrathecal bac lofen delivered by an implanted programmable pump is a safe, effective , and cost-efficient method for treatment of severe intractable spinal spasticity.