Effect of intrathecal baclofen delivered by an implantedprogrammable pump on health related quality of life in patients withsevere spasticity

OBJECTIVES—To compare clinical effectiveness andhealth related quality of life in patients with severe spasticity whoreceived intrathecal baclofen or a placebo.
METHODS—In a double blind, randomised,multicentre trial 22 patients were followed up during 13 weeks andsubsequently included in a 52 week observational longitudinal study.Patients were those with chronic, disabling spasticity who did notrespond to maximum doses of oral baclofen, dantrolene, and tizanidine.After implantation of a programmable pump patients were randomlyassigned to placebo or baclofen infusion for 13 weeks. After 13 weeksall patients received baclofen. Clinical efficacy was assessed by theAshworth scale, spasm score, and self reported pain, and health related quality of life by the sickness impact profile (SIP) and the Hopkins symptom checklist (HSCL).
RESULTS—At three months the scores of the placeboand baclofen group differed slightly for the spasm score (effectsize=0.20) and substantially for the Ashworth scale (effect size=1.40)and pain score (effect size=0.94); health related quality of lifeshowed no significant differences. Three months after implantation the baclofen group showed a significant, substantial improvement on the SIP"physical health", "mental health", "mobility", and"sleep and rest" subscales and on the HSCL mental health scale;patients receiving placebo showed no change. After one year of baclofen treatment significant (P<0.05) improvement was found on the SIP dimensions "mobility" and "body care and movement" withmoderate effect sizes. Improvement on the SIP subscale "physicalhealth" (P<0.05; effect size 0.86), the SIP overall score (without"ambulation"), and the "physical health" and overall scale ofthe HSCL was also significant, with effect sizes >0.80. Changes inhealth related behaviour were noted for "sleep and rest" and"recreation and pastimes" (P<0.01, P<0.05; effect size 0.95 and0.63, respectively). Psychosocial behaviour showed no improvement.
CONCLUSIONS—Intrathecal baclofen delivered by animplanted, programmable pump resulted in improved self reported qualityof life as assessed by the SIP, and HSCL physical health dimensionsalso suggest improvement.