Benefits and Risks – ITB Therapy

Although ITB TherapySM won’t eliminate the primary source of your condition or severe spasticity, it may help you manage the tight, stiff muscles that make daily living more difficult for you.

Benefits of ITB Therapy

ITB Therapy has been shown to benefit people who have been affected by multiple sclerosis, spinal cord injury, brain injury, stroke, and cerebral palsy in the following ways:

  • Multiple studies show it significantly reduces spasticity and spasms.1-9
  • In at least seven studies the therapy has helped people become more independent, allowing them to perform activities of daily living including feeding or dressing themselves, sitting more comfortably, or transferring more easily.10-16
  • Some studies have reported caregiver satisfaction with ITB Therapy.13-17

For people whose spasticity is of spinal origin (multiple sclerosis or spinal cord injury):

  • A study showed that ITB Therapy may provide long-term control of spasticity5
  • A study revealed ITB Therapy results in improved function18

A study found that, for patients living with multiple sclerosis, the timely management of severe spasticity may contribute to the maintenance of long-term ambulation.19

Risks Associated with ITB Therapy

Please follow your doctor’s instruction closely because a sudden stop of ITB Therapy can result in serious illness (withdrawal symptoms) such as high fever, changed mental status, muscle rigidity, and in rare cases multiple organ-system failure and death. It is very important that your doctor be called right away if you experience any of the above symptoms.

It is important for you to keep your scheduled refill visits so you don’t run out of medication and to understand the early symptoms of withdrawal. Some people are at more risk than others for withdrawal; consult with your doctor.

Side effects associated with ITB Therapy usually are temporary and can be managed by adjusting the dosage of the drug in the pump.

The most common side effects include:

  • Loose muscles
  • Sleepiness
  • Upset stomach
  • Nausea/vomiting
  • Headache
  • Dizziness

Pump failure may cause an overdose or underdose. The signs and symptoms of an overdose include:

  • Drowsiness
  • Lightheadedness
  • Difficulty breathing
  • Seizures
  • Loss of consciousness or coma

The signs and symptoms of an underdose include:

  • Increase or return of spasticity
  • Itching
  • Low blood pressure
  • Lightheadedness
  • Tingling sensation

Following are possible device complications:

  • The catheter or pump could move within the body or push through the skin
  • The pump could stop because the battery has run out or because of component failure
  • The catheter could leak, tear, kink, or become disconnected resulting in an underdose or abrupt cessation of drug delivery. An abrupt stop of anti-spastic medication can lead to:
    • High fever
    • Altered mental status
    • Returned spasticity
    • Muscle rigidity
    • Death, in rare cases

It is important to note that the pump will sound an alarm when the pump needs to be replaced, filled with medication or if there is a problem with the pump.

Always inform a healthcare professional that you have an implanted infusion system before any medical or diagnostic procedure (e.g., MRI, diathermy, etc.).

References:

  1. Francisco GC, Boake C. Improvement in walking speed in poststroke spastic hemiplegia after intrathecal baclofen therapy: a preliminary study. Arch Phys Med Rehabil. 2003;84(8):1194-1199.
  2. Meythaler JM, Guin-Refroe S, Brunner RC, Hadley MN. Intrathecal baclofen for spastic hypertonia from stroke. Stroke. 2001;32(9):2099-2109.
  3. Ivanhoe CB, Francisco GE, McGuire JR, Subramanian T, Grissom SP. Intrathecal baclofen management of poststroke spastic hypertonia: implications for function and quality of life. Arch Phys Med Rehabil. 2006;87(11):1509–1515.
  4. Gilmartin R. Intrathecal baclofen for management of spastic cerebral palsy: multicenter trial. J Child Neurol. 2000;15(2):71-77.
  5. Penn RD. Intrathecal baclofen for spasticity of spinal origin: seven years of experience. J Neurosurg. 1992;77(2):236-240.
  6. Albright AL, Gilmartin R, Swift D, Krach LE, Ivanhoe CB, McLaughlin JF. Long-term intrathecal baclofen therapy for severe spasticity of cerebral origin. J Neurosurg. 2003;98(2):291-295.
  7. Coffey RJ, Cahill D, Steers W. Intrathecal baclofen for intractable spasticity of spinal origin: results of a long-term multicenter study. J Neurosurg. 1993;78(6):226-232.
  8. Ordia JI, Fischer E, Adamski E, Chagnon KG, Spatz EL. Continuous intrathecal baclofen infusion by a programmable pump in 131 consecutive patients with severe spasticity of spinal origin. Neuromodulation. 2002; 5(1):16-24.
  9. Becker R, Alberti O, Bauer BL. Continuous intrathecal baclofen infusion in severe spasticity after traumatic or hypoxic brain injury. J Neurol. 1997; 244(3):160-166.
  10. Nance P, Schryvers O, Schmidt B, Dubo H, Loveridge B, Fewer D. Intrathecal baclofen therapy for adults with spinal spasticity: therapeutic efficacy and effect on hospital admissions. Can J Neurol Sci. 1995 Feb: 22(1):22-29.
  11. Krach LE, Kriel RL, Gilmartin RC, et al., GMFM 1 year after continuous intrathecal baclofen infusion. Pediatr Rehabil. 2005 Jul-Sep; 8(3): 207-213.
  12. Krach LE, Nettleton A, Klempka B. Satisfaction of individuals treated long-term with continuous infusion of intrathecal baclofen by implanted programmable pump. Pediatr Rehabil. 2006 Jul-Sep; 9(3):210-218.
  13. Gooch JL, Oberg WA, Grams B, et al., Care provider assessment of intrathecal baclofen in children. Dev Med & Child Neurol. 2004 Aug; 46(8):548-552.
  14. Parke B, Penn RD, Savoy SM, Corcos D. Functional outcome following delivery of intrathecal baclofen. Arch Phys Med Rehabil. 1989;70(1):30-32.
  15. Azouvi P, Mane M, Thiebaut JB, Denys P, Remy-Neris O, Bussel B. Intrathecal baclofen administration for control of severe spinal spasticity: functional improvement and long-term follow-up. Arch Phys Med Rehabil. 1996;77(1):35-39.
  16. Stempien L, Tsai T. Intrathecal baclofen pump use for spasticity: a clinical survey. Am J Phys Med Rehabil. 2000;79(6):536-541.
  17. Campbell WM, Ferrel A, McLaughlin JF, et al. Long-term safety and efficacy of continuous intrathecal baclofen. Dev Med Child Neurol. 2002;44(10):660-665.
  18. Dario A, Scamoni C, Bono G, Ghezzi A, Zaffaroni M. Functional improvement in patients with severe spinal spasticity treated with chronic intrathecal baclofen infusion. Funct Neurol. 2001;16(4):311-315
  19. Sadiq SA, Wang GC. Long-term intrathecal baclofen therapy in ambulatory patients with spasticity. J Neurol. 2006:253(5):563-569.

Information on this site should not be used as a substitute for talking with your doctor. Always talk with your doctor about diagnosis and treatment information.

Last updated: 22 Sep 2010

Section Navigation

Additional information

Contact Us

Medtronic International Trading Sàrl
Medtronic
Case postale
Route du Molliau 31
CH-1131 Tolochenaz
work Tel. +41 (0)21 802 70 00
work Fax +41 (0)21 802 79 00
Europe