EVect of intrathecal baclofen delivered by an implanted programmable pump on health related quality of life in patients with severe spasticity

Objectives—To compare clinical eVectiveness and health related quality of life in patients with severe spasticity who received intrathecal baclofen or a placebo. Methods—In a double blind, randomised, multicentre trial 22 patients were followed up during 13 weeks and subsequently included in a 52 week observational longitudinal study. Patients were those with chronic, disabling spasticity who did not respond to maximum doses of oral baclofen, dantrolene, and tizanidine. After implantation of a programmable pump patients were randomly assigned to placebo or baclofen infusion for 13 weeks. After 13 weeks all patients received baclofen. Clinical eYcacy was assessed by the Ashworth 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 threemonths the scores of the placebo and baclofen group diVered slightly for the spasm score (eVect size=0.20) and substantially for the Ashworth scale (eVect size=1.40) and pain score (eVect size=0.94); health related quality of life showed no significant diVerences. 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” with moderate eVect sizes. Improvement on the SIP subscale “physical health” (P<0.05; eVect size 0.86), the SIP overall score (without “ambulation”), and the “physical health” and overall scale of the HSCL was also significant, with eVect sizes >0.80. Changes in health related behaviour were noted for “sleep and rest” and “recreation and pastimes” (P<0.01, P<0.05; eVect size 0.95 and 0.63, respectively). Psychosocial behaviour showed no improvement. Conclusions—Intrathecal baclofen delivered by an implanted, programmable pump resulted in improved self reported quality of life as assessed by the SIP, and HSCL physical health dimensions also suggest improvement. (J Neurol Neurosurg Psychiatry 1997;63:204–209)