EFFECT OF INTRATHECAL BACLOFEN DELIVERED BY AN IMPLANTED PROGRAMMABLEPUMP ON HEALTH-RELATED QUALITY-OF-LIFE IN PATIENTS WITH SEVERE SPASTICITY

Objectives-To compare clinical effectiveness and health related qualit y of life in patients with severe spasticity who received intrathecal baclofen or a placebo. Methods-In a double blind, randomised, multicen tre trial 22 patients were followed up during 13 weeks and subsequentl y included in a 52 week observational longitudinal study. Patients wer e those with chronic, disabling spasticity who did not respond to maxi mum doses of oral baclofen, dantrolene, and tizanidine. After implanta tion of a programmable pump patients were randomly assigned to placebo or baclofen infusion for 13 weeks. After 13 weeks all patients receiv ed baclofen. Clinical efficacy was assessed by the Ashworth scale, spa sm score, and self reported pain, and health related quality of life b y the sickness impact profile (SIP) and the Hopkins symptom checklist (HSCL). Results-At three months the scores of the placebo and baclofen group differed slightly for the spasm score (effect size = 0.20) and substantially for the Ashworth scale (effect size = 1.40) and pain sco re (effect size = 0.94); health related quality of life showed no sign ificant differences. Three months after implantation the baclofen grou p showed a significant, substantial improvement on the SIP ''physical health'', ''mental health'', ''mobility'', and ((sleep and rest)) subs cales 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 effect sizes. Improvement on t he SIP subscale ''physical health'' (P < 0.05; effect size 0.86), the SIP overall score (without ''ambulation'', and the ''physical health'' and overall scale of the HSCL was also significant, with effect sizes > 0.80. Changes in health related behaviour were noted for ''sleep an d rest'' and ''recreation and pastimes'' (P < 0.01, P < 0.05; effect s ize 0.95 and 0.63, respectively). Psychosocial behaviour showed no imp rovement. Conclusions-Intrathecal baclofen delivered by an implanted, programmable pump resulted in improved self reported quality of life a s assessed by the SIP, and HSCL physical health dimensions also sugges t improvement.