Chronic intrathecal delivery of baclofen by a programmable pump for the treatment of severe spasticity

View More View Less
  • 1 Department of Neurosurgery, Boston University Medical Center Hospital, and Boston University School of Medicine, Boston, Massachusetts
Restricted access

Purchase Now

USD  $45.00

JNS + Pediatrics - 1 year subscription bundle (Individuals Only)

USD  $515.00

JNS + Pediatrics + Spine - 1 year subscription bundle (Individuals Only)

USD  $612.00
Print or Print + Online

✓ The aim of this study was to determine the efficacy, safety, and cost-effectiveness of intrathecal baclofen delivered by a programmable pump for the chronic treatment of severe spasticity. Sixty-six patients with severe spasticity of spinal cord origin that was refractory to oral baclofen or who experienced intolerable side effects with this form of the drug were screened. The first nine participated in a double-blinded, randomized, placebo (normal saline)-controlled trial to determine response to a bolus dose of intrathecal baclofen. Subsequent patients were enrolled in an open-label treatment protocol without a placebo trial. All passed the screening, and the pump was implanted in 59 patients. Spasticity scores and medical costs before and after surgery were analyzed.

In all patients, the mean Ashworth score for rigidity decreased from 4.3 preoperatively to 1.4 (p < 0.0005) with use of intrathecal baclofen. The spasm frequency score decreased from a mean of 3.6 to 0.5 (p < 0.0005). Activities of daily living, sleep, and skin integrity improved, and pain was eradicated in some. Constipation occurred in six patients. A reduction in dosage was necessitated by muscular hypotonia in three ambulatory patients, areflexic bladder and urinary retention in three others, and nausea, dizziness, and drowsiness in one. Catheter-related problems occurred 19 times in 15 patients. One pump was explanted because of infection in the pump pocket, and one was removed after it eroded through the skin. There were no pump failures. The use of intrathecal baclofen resulted in a decrease in the average length of subsequent hospitalizations. It is concluded that intrathecal baclofen delivered by an implanted programmable pump is a safe, effective, and cost-efficient method for treatment of severe intractable spinal spasticity.

JNS + Pediatrics - 1 year subscription bundle (Individuals Only)

USD  $515.00

JNS + Pediatrics + Spine - 1 year subscription bundle (Individuals Only)

USD  $612.00
  • 1.

    Abel NA, & Smith RA: Intrathecal baclofen for treatment of intractable spinal spasticity. Arch Phys Med Rehabil 75:5458, 1994 Abel NA, Smith RA: Intrathecal baclofen for treatment of intractable spinal spasticity. Arch Phys Med Rehabil 75:54–58, 1994

    • Search Google Scholar
    • Export Citation
  • 2.

    Ashworth B: Preliminary trial of carisoprodol in multiple sclerosis. Practitioner 192:540542, 1964 Ashworth B: Preliminary trial of carisoprodol in multiple sclerosis. Practitioner 192:540–542, 1964

    • Search Google Scholar
    • Export Citation
  • 3.

    Bowery NG: Baclofen: 10 years on. Trends Pharmacol Sci 3:400403, 1982 Bowery NG: Baclofen: 10 years on. Trends Pharmacol Sci 3:400–403, 1982

    • Search Google Scholar
    • Export Citation
  • 4.

    Bushman W, , Steers WD, & Meythaler JM: Voiding dysfunction in patients with spastic paraplegia: urodynamic evaluation and response to continuous intrathecal baclofen. Neurourol Urodyn 12:163170, 1993 Bushman W, Steers WD, Meythaler JM: Voiding dysfunction in patients with spastic paraplegia: urodynamic evaluation and response to continuous intrathecal baclofen. Neurourol Urodyn 12:163–170, 1993

    • Search Google Scholar
    • Export Citation
  • 5.

    Chabal C, , Jacobson L, & Terman G: Intrathecal fentanyl alleviates spasticity in the presence of tolerance to intrathecal baclofen. Anesthesiology 76:312314, 1992 Chabal C, Jacobson L, Terman G: Intrathecal fentanyl alleviates spasticity in the presence of tolerance to intrathecal baclofen. Anesthesiology 76:312–314, 1992

    • Search Google Scholar
    • Export Citation
  • 6.

    Coffey RJ, , Cahill D, & Steers W, et al: Intrathecal baclofen for intractable spasticity of spinal origin: results of a long-term multicenter study. J Neurosurg 78:226232, 1993 Coffey RJ, Cahill D, Steers W, et al: Intrathecal baclofen for intractable spasticity of spinal origin: results of a long-term multicenter study. J Neurosurg 78:226–232, 1993

    • Search Google Scholar
    • Export Citation
  • 7.

    Corston RN, , Johnson F, & Godwin-Austen RB: The assessment of drug treatment of spastic gait. J Neurol Neurosurg Psychiatry 44:10351039, 1981 Corston RN, Johnson F, Godwin-Austen RB: The assessment of drug treatment of spastic gait. J Neurol Neurosurg Psychiatry 44:1035–1039, 1981

    • Search Google Scholar
    • Export Citation
  • 8.

    Delhaas EM, & Brouwers JR: Intrathecal baclofen overdose: report of 7 events in 5 patients and review of the literature. Int J Clin Pharmacol Ther Toxicol 29:274280, 1991 Delhaas EM, Brouwers JR: Intrathecal baclofen overdose: report of 7 events in 5 patients and review of the literature. Int J Clin Pharmacol Ther Toxicol 29:274–280, 1991

    • Search Google Scholar
    • Export Citation
  • 9.

    Erickson DL, , Blacklock JB, & Michaelson M, et al: Control of spasticity by implantable continuous flow morphine pump. Neurosurgery 16:215217, 1985 Erickson DL, Blacklock JB, Michaelson M, et al: Control of spasticity by implantable continuous flow morphine pump. Neurosurgery 16:215–217, 1985

    • Search Google Scholar
    • Export Citation
  • 10.

    Erickson DL, , Moreno P, & Lo J, et al: Control of spasticity with intrathecal morphine sulfate, in Müller H, , Zierski J, & Penn RD (eds): Local-Spinal Therapy of Spasticity. Berlin: Springer-Verlag, 1988, pp 137142 Erickson DL, Moreno P, Lo J, et al: Control of spasticity with intrathecal morphine sulfate, in Müller H, Zierski J, Penn RD (eds): Local-Spinal Therapy of Spasticity. Berlin: Springer-Verlag, 1988, pp 137–142

    • Search Google Scholar
    • Export Citation
  • 11.

    Herman RM, , D'Luzansky SC, & Ippolito R: Intrathecal baclofen suppresses central pain in patients with spinal lesions. A pilot study. Clin J Pain 8:338345, 1992 Herman RM, D'Luzansky SC, Ippolito R: Intrathecal baclofen suppresses central pain in patients with spinal lesions. A pilot study. Clin J Pain 8:338–345, 1992

    • Search Google Scholar
    • Export Citation
  • 12.

    Jones RF, , Burke D, & Marosszeky JE, et al: A new agent for the control of spasticity. J Neurol Neurosurg Psychiatry 33:464468, 1970 Jones RF, Burke D, Marosszeky JE, et al: A new agent for the control of spasticity. J Neurol Neurosurg Psychiatry 33:464–468, 1970

    • Search Google Scholar
    • Export Citation
  • 13.

    Kofler M, , Kronenberg MF, & Rifici C, et al: Epileptic seizures associated with intrathecal baclofen application. Neurology 44:2527, 1994 Kofler M, Kronenberg MF, Rifici C, et al: Epileptic seizures associated with intrathecal baclofen application. Neurology 44:25–27, 1994

    • Search Google Scholar
    • Export Citation
  • 14.

    Kraft CH, & van Eeden C: A Nonparametric Introduction to Statistics. New York: Macmillan, 1968 Kraft CH, van Eeden C: A Nonparametric Introduction to Statistics. New York: Macmillan, 1968

    • Search Google Scholar
    • Export Citation
  • 15.

    Kroin JS, , Penn RD, & Beissinger RL, et al: Reduced spinal reflexes following intrathecal baclofen in the rabbit. Exp Brain Res 54:191194, 1984 Kroin JS, Penn RD, Beissinger RL, et al: Reduced spinal reflexes following intrathecal baclofen in the rabbit. Exp Brain Res 54:191–194, 1984

    • Search Google Scholar
    • Export Citation
  • 16.

    Lance JW: Symposium synopsis, in Feldman RG, , Young RR, & Koella WP (eds): Spasticity: Disordered Motor Control. Chicago: Year Book, 1980, pp 485494 Lance JW: Symposium synopsis, in Feldman RG, Young RR, Koella WP (eds): Spasticity: Disordered Motor Control. Chicago: Year Book, 1980, pp 485–494

    • Search Google Scholar
    • Export Citation
  • 17.

    Latash ML, , Penn RD, & Corcos DM, et al: Effects of intrathecal baclofen on voluntary motor control in spastic paresis. J Neurosurg 72:388392, 1990 Latash ML, Penn RD, Corcos DM, et al: Effects of intrathecal baclofen on voluntary motor control in spastic paresis. J Neurosurg 72:388–392, 1990

    • Search Google Scholar
    • Export Citation
  • 18.

    McDowell FH: Treatment of spasticity. Drugs 22:401408, 1981 McDowell FH: Treatment of spasticity. Drugs 22:401–408, 1981

  • 19.

    Müller H, , Zierski J, & Dralle D, et al: Intrathecal baclofen in spasticity, in Müller H, , Zierski J, & Penn RD (eds): Local-Spinal Therapy of Spasticity. Berlin: Springer-Verlag, 1988, pp 155214 Müller H, Zierski J, Dralle D, et al: Intrathecal baclofen in spasticity, in Müller H, Zierski J, Penn RD (eds): Local-Spinal Therapy of Spasticity. Berlin: Springer-Verlag, 1988, pp 155–214

    • Search Google Scholar
    • Export Citation
  • 20.

    Müller-Schwefe G, & Penn RD: Physostigmine in the treatment of intrathecal baclofen overdose. Report of three cases. J Neurosurg 71:273275, 1989 Müller-Schwefe G, Penn RD: Physostigmine in the treatment of intrathecal baclofen overdose. Report of three cases. J Neurosurg 71:273–275, 1989

    • Search Google Scholar
    • Export Citation
  • 21.

    Nance P, , Schryvers O, & Schmidt B, et al: Intrathecal baclofen therapy for adults with spinal spasticity: therapeutic efficacy and effect on hospital admissions. Can J Neurol Sci 22:2229, 1995 Nance P, Schryvers O, Schmidt B, et al: Intrathecal baclofen therapy for adults with spinal spasticity: therapeutic efficacy and effect on hospital admissions. Can J Neurol Sci 22:22–29, 1995

    • Search Google Scholar
    • Export Citation
  • 22.

    Nanninga JB, , Frost F, & Penn R: Effect of intrathecal baclofen on bladder and sphincter function. J Urol 142:101105, 1989 Nanninga JB, Frost F, Penn R: Effect of intrathecal baclofen on bladder and sphincter function. J Urol 142:101–105, 1989

    • Search Google Scholar
    • Export Citation
  • 23.

    Ordia JI, & Schultz BK: Intrathecal baclofen in the management of severe spasticity. Pharmacol Ther 19:461472, 1994 Ordia JI, Schultz BK: Intrathecal baclofen in the management of severe spasticity. Pharmacol Ther 19:461–472, 1994

    • Search Google Scholar
    • Export Citation
  • 24.

    Parke B, , Penn RD, & Savoy SM, et al: Functional outcome following delivery of intrathecal baclofen. Arch Phys Med Rehabil 70:3032, 1989 Parke B, Penn RD, Savoy SM, et al: Functional outcome following delivery of intrathecal baclofen. Arch Phys Med Rehabil 70:30–32, 1989

    • Search Google Scholar
    • Export Citation
  • 25.

    Penn RD: Intrathecal baclofen for spasticity of spinal origin: seven years of experience. J Neurosurg 77:236240, 1992 Penn RD: Intrathecal baclofen for spasticity of spinal origin: seven years of experience. J Neurosurg 77:236–240, 1992

    • Search Google Scholar
    • Export Citation
  • 26.

    Penn RD, & Kroin JS: Continuous intrathecal baclofen for severe spasticity. Lancet 2:125127, 1985 Penn RD, Kroin JS: Continuous intrathecal baclofen for severe spasticity. Lancet 2:125–127, 1985

    • Search Google Scholar
    • Export Citation
  • 27.

    Penn RD, & Kroin JS: Intrathecal baclofen alleviates spinal cord spasticity. Lancet 1:1078, 1984 (Letter) Penn RD, Kroin JS: Intrathecal baclofen alleviates spinal cord spasticity. Lancet 1:1078, 1984 (Letter)

    • Search Google Scholar
    • Export Citation
  • 28.

    Penn RD, , Savoy SM, & Corcos D, et al: Intrathecal baclofen for severe spinal spasticity. N Engl J Med 320:15171521, 1989 Penn RD, Savoy SM, Corcos D, et al: Intrathecal baclofen for severe spinal spasticity. N Engl J Med 320:1517–1521, 1989

    • Search Google Scholar
    • Export Citation
  • 29.

    Rosenson AS, , Ali A, & Fordham EW, et al: Indium-111 DTPA flow study to evaluate surgically implanted drug pump delivery system. Clin Nucl Med 15:154156, 1990 Rosenson AS, Ali A, Fordham EW, et al: Indium-111 DTPA flow study to evaluate surgically implanted drug pump delivery system. Clin Nucl Med 15:154–156, 1990

    • Search Google Scholar
    • Export Citation
  • 30.

    Steers WD, , Meythaler JM, & Haworth C, et al: Effects of acute bolus and chronic continuous intrathecal baclofen on genitourinary dysfunction due to spinal cord pathology. J Urol 148:18491855, 1992 Steers WD, Meythaler JM, Haworth C, et al: Effects of acute bolus and chronic continuous intrathecal baclofen on genitourinary dysfunction due to spinal cord pathology. J Urol 148:1849–1855, 1992

    • Search Google Scholar
    • Export Citation
  • 31.

    Taira T, , Tanikawa T, & Kawamura H, et al: Spinal intrathecal baclofen suppresses central pain after a stroke. J Neurol Neurosurg Psychiatry 57:381382, 1994 (Letter) Taira T, Tanikawa T, Kawamura H, et al: Spinal intrathecal baclofen suppresses central pain after a stroke. J Neurol Neurosurg Psychiatry 57:381–382, 1994 (Letter)

    • Search Google Scholar
    • Export Citation
  • 32.

    Wilson PR, & Yaksh TL: Baclofen is antinociceptive in the spinal intrathecal space of animals. Eur J Pharmacol 51:323330, 1978 Wilson PR, Yaksh TL: Baclofen is antinociceptive in the spinal intrathecal space of animals. Eur J Pharmacol 51:323–330, 1978

    • Search Google Scholar
    • Export Citation
  • 33.

    Young RR, & Delwaide PJ: Drug therapy: spasticity. N Engl J Med 304:9699, 1981 Young RR, Delwaide PJ: Drug therapy: spasticity. N Engl J Med 304:96–99, 1981

    • Search Google Scholar
    • Export Citation
  • 34.

    Zierski J, & Mueller H: Surgical treatment of spasticity—a review, in Müller H, , Zierski J, & Penn RD (eds): Local-Spinal Therapyof Spasticity. Berlin: Springer-Verlag, 1988, pp 255263 Zierski J, Mueller H: Surgical treatment of spasticity—a review, in Müller H, Zierski J, Penn RD (eds): Local-Spinal Therapyof Spasticity. Berlin: Springer-Verlag, 1988, pp 255–263

    • Search Google Scholar
    • Export Citation

Metrics

All Time Past Year Past 30 Days
Abstract Views 828 255 14
Full Text Views 181 14 1
PDF Downloads 141 17 1
EPUB Downloads 0 0 0