Benefits and Risks – ITB Therapy

Although Medtronic ITB Therapy^SM (the baclofen pump) 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 (Intrathecal Baclofen Therapy), also called the baclofen pump, has been shown to benefit people who have been affected by brain injury, stroke, cerebral palsy, multiple sclerosis, and spinal cord injury 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 cerebral origin (cerebral palsy, brain injury, or stroke):

• A study found that ITB Therapy may provide long-term control of spasticity in people living with cerebral palsy or brain injury.⁶
• A number of studies have determined ITB Therapy reduces spasticity in both the upper and lower limbs of those living with cerebral palsy, brain injury and stroke.^2,3,18-20

In another study, ITB Therapy was shown to improve hygiene and transfer scores in patients living with brain injury.²¹

Risks Associated with ITB Therapy

Please follow your doctor’s instruction closely because a sudden stop of intrathecal baclofen therapy can result in serious illness (baclofen 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 (intrathecal baclofen) and to understand the early symptoms of baclofen withdrawal. Some people are at more risk than others for baclofen withdrawal; consult with your doctor.

Side affects associated with ITB Therapy (the baclofen pump) usually are temporary and can be managed by adjusting the dosage of intrathecal baclofen (the drug contained 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 of intrathecal baclofen. 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 intrathecal baclofen. An abrupt stop of intrathecal baclofen 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 baclofen 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.).

For more information, please read the Lioresal^® Intrathecal (baclofen injection) Full Prescribing Information and the SynchroMed^® Infusion System Information.

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. Meythaler JM, Guin-Renfroe S, Grabb P, Hadley MN. Long-term continuously infused intrathecal baclofen for spastic-dystonic hypertonia in traumatic brain injury: 1-year experience. Arch Phys Med Rehabil. 1999;80(1):13-19.
19. Francisco GE, Hu MM, Boake C, Ivanhoe CB. Efficacy of early use of intrathecal baclofen therapy for treating spastic hypertonia due to acquired brain injury. Brain Injury. 2005;19(5):359-364.
20. Meythaler JM, Guin-Renfroe S, Law C, Grabb P, Hadley MN. Continuously infused intrathecal baclofen over 12 months for spastic hypertonia in adolescents and adults with cerebral palsy. Arch Phys Med Rehabil. 2001;82(2):155-161.
21. Krach LE, Kriel RL, Gilmartin RC, et al. Hip Status in cerebral palsy after one year of continuous intrathecal baclofen infusion. Pediatric Neurology. Aug 2003;30(3):163-8.
22. Gerszten PC, Albright AL, Johnstone GF. Intrathecal baclofen infusion and subsequent orthopedic surgery in patients with spastic cerebral palsy. J Neurosurg. 1998;88(6):1009-1013.

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