Intrathecal Baclofen Therapy for Adults with Spinal Spasticity: Therapeutic Efficacy and Effect on Hospital Admissions

Abstract

ABSTRACT:A prospective trial to demonstrate the efficacy of intrathecal baclofen therapy by implanted pump for adults with spasticity due to spinal cord injury or multiple sclerosis was initiated in our hospital. Of the 140 patients assessed, 7 met the following criteria for inclusion in the study: a modified Ashworth score > 3, a spasm frequency score > 2, and an inadequate response to oral antispasticity drugs, (i.e., baclofen, clonidine and cyproheptadine). All patients responded to intrathecal bolus injection of baclofen in the double blind, placebo-controlled screening phase (mean bolus dose = 42.8 ug). Programmable Medtronic pumps were implanted in 4 patients while 3 patients received nonprogrammable Infusaid pumps. Post-implantation, a marked decrease in spasticity occurred with a significant reduction of the Ashworth score (mean = 1.8, p < .005), a reduced spasm score (mean = 0.8, p < .005), and an improved leg swing in the pendulum test. These effects were maintained during a follow-up of 24 -41 months (average infusion dose = 218.7 ug/day). The gross cost-savings due to reduced hospitalizations related to spasticity was calculated by comparing the cost for the two year period before pump implantation to the same period after treatment for 6 of the 7 patients. The cost of in-hospital implantation as well as the cost of the pumps were deducted from the gross savings. There was a net cost-saving of $153,120. Our findings agree with the reported efficacy and safety of intrathecal baclofen treatment, and illustrate the cost-effectiveness of this treatment. RESUME: Le baclofen intrathecal chez les adultes avec spasticite spinale: efficacite therapeutique et consequences sur les admissions hospitalieres. Cette etude prospective avait pour but de demontrer 1'efficacite du baclofen intrathecal, administre au moyen d'une pompe, chez des adultes avec spasticite due a un traumatisme de la moelle epiniere ou a la sclerose en plaques. Des 140 patients evalues, seulement 7 repondaient a nos criteres d'inclusion au projet soit: pointage a I'echelle Ashworth modifiee > 3, pointage de la frequence des spasmes > 2, reponse inadequate aux medicaments antispastiques oraux tels que le baclofen, la clonidine et la cyproheptadine. Tous les sujets ont repondu a 1'injection d'un bolus intrathecal de baclofen dans la phase de selection impliquant une epreuve a double insu avec placebo (dose moyenne du bolus: 42.8 pg). La pompe programmable Medtronic a ete implantee chez 4 patients et la pompe non programmable Infusaid chez 3 patients. Suite a 1'implantation, nous avons observe 1 une diminution remarquable de la spasticite, une reduction significative du pointage a I'echelle Ashworth (moyenne 1.8, p < 0.005) et de la frequence des spasmes (moyenne 0.8), ainsi qu'une augmentation de Pamplitude du mouvement de la jambe dans I'epreuve pendulaire. Ces effets ont efe maintenus pendant une periode de 24 a 41 mois avec une dose d'infusion moyenne de 218.7 pg/jour. Le cout total des soins hospitaliers pendant les deux ans qui ont precede...

Treatment of severe, disabling spasticity with continuous intrathecal baclofen therapy following acquired brain injury: the experience of a tertiary institution in Singapore

“…(5) Intrathecal baclofen (ITB) therapy has now become a widely recognised treatment for severe, disabling spasticity in individuals with cerebral palsy, stroke, and spinal cord and brain injuries. (6)(7)(8)(9)(10)(11)(12)(13)(14) Other benefi ts of ITB therapy include reduction of central pain, improvement in cerebral dysautonomia and improvements in disorders of consciousness. (15,16) Despite the established therapeutic value of ITB therapy, there is a paucity of local literature.…”

Treatments for spasticity and pain in multiple sclerosis: a systematic review

“…The study showed no significant difference between patients and controls in the number of hospital days in the year following CIBI. For the implantation year there were 18.7 days used on average by the control group compared with an estimated average of 20.7 days related to the CIBI procedure and no further days related to spasticity for the CIBI group.These papers provide three separate estimates of bed days used for patients without or prior to CIBI: 19 days, 89 32 days (63 days over 2 years) 88 and 84 days. 68 The differences are almost certainly due to differences in patient selection and care settings.…”

Cost-Effectiveness Analysis of Intrathecal Baclofen Therapy in Japan

“…1,2,4,7,12,[17][18][19][20][21] Cost per QALY ranged from $10,550 to $19,570, well below the $50,000 willingness-to-pay for 1 QALY regarded as the guideline for evaluating the value of medical technologies. In the present study, the cost per QALY of ITB therapy in Japan was 1,554,428 yen, or $19,430 in U.S. dollars, far below the $50,000 figure.…”