Effect of intrathecal baclofen delivered by an implanted programmable pump on health related quality of life in patients with severe spasticity
- Berrie Middela,
- Hanna Kuipers-Upmeijerb,
- Jelte Boumaa,
- Michiel Staalc,
- Dettie Oenemab,
- Theo Postmae,
- Sijmon Terpstrad,
- Roy Stewarta
- aNorthern Centre for Health Care Research, Faculty of Medical Sciences, bDepartment of Neurology, cDepartment of Neurosurgery, dDepartment of Long-Range Planning, eFaculty of Economics, University of Groningen, the Netherlands
- Berrie Middel, Northern Centre for Healthcare Research, University of Groningen, Ant Deusinglaan 1, 9713 AV Groningen, The Netherlands.
- Received 1 October 1996
- Revised 17 March 1997
- Accepted 25 March 1997
Abstract
OBJECTIVES To compare clinical effectiveness 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 efficacy 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 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 score (effect size=0.94); health related quality of life showed 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” with moderate effect sizes. Improvement on the 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 and rest” and “recreation and pastimes” (P<0.01, P<0.05; effect 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.
