Ji. Ordia et al., CHRONIC INTRATHECAL DELIVERY OF BACLOFEN BY A PROGRAMMABLE PUMP FOR THE TREATMENT OF SEVERE SPASTICITY, Journal of neurosurgery, 85(3), 1996, pp. 452-457
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.