Advantages of ITB Therapy
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| Jason F., living with spinal cord injury.
Receiving ITB Therapy since 1991. |
In addition to statistically significant reductions in severe spasticity,1-4 studies
have shown that ITB Therapy offers the potential for reduced central
nervous system side effects that are associated with oral medications,5 improvements
in independence and caregiving,6-12 as
well as high patient and caregiver satisfaction.9,13,14
Additionally, studies show reduction in spasticity-related
pain,7,15,16 and
improvement in function and physical activity.7,10,15,17
Reduced side effects
Because ITB Therapy delivers baclofen directly to the spinal cord, it relieves spasticity with smaller amounts of medication than when taken orally. This helps minimize systemic side effects.
Introducing Lioresal® Intrathecal directly into the intrathecal space
permits effective CSF concentrations to be achieved with resultant plasma
concentrations 100 times less than those occurring with oral administration.19
Improvements in independence and caregiving
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.6-12
Physician, patient, and caregiver satisfaction
Physician satisfaction
In a clinical study, 87% of physicians rated their overall satisfaction
with ITB Therapy for each patient as “good” or “very
good.”15
Patient satisfaction
In a clinical study, the authors concluded that “ITB Therapy
demonstrated the highest satisfaction rating compared to all oral treatments:
the mean rating score of 4.47 on a scale of 5 indicates substantially more
gratification among patients than the next most satisfactory...(which had)
a mean score of 3.89.”14
In another study, 82% of patients and caregivers indicated they would
repeat their decision to implant the pump. In addition, 85% reported
their goals were fully or partially met.7
Caregiver satisfaction
A high rate of caregiver satisfaction with ITB Therapy has also been reported in the following studies.
- More than 81% of 80 care providers “strongly agreed” that
they would repeat the decision to undergo the pump procedure9
- More than 88% (15 of 17) would recommend the therapy to others13
1. Gilmartin R, Bruce D, Storrs BB, et al. Intrathecal baclofen for management
of spastic cerebral palsy: multicenter trial. J Child
Neurol. 2000;15(2):71-77.
2. 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
3. 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.
4. Penn
RD. Intrathecal baclofen for spasticity of spinal origin: seven years experience.
J Neurosurg. 1992;77(2):236-240.
5. Loubser PG, Narayan RK, Sandin KJ, Donovan WH, Russell
KD. Continuous infusion of intrathecal baclofen: long-term effects on spasticity
in spinal cord injury. Paraplegia. 1991:29(1):48-64.
6. 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
7. 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; 9(3): 210-218.
8. Krach LE, Kriel RL, Gilmartin RC, et al. GMFM 1 year
after continuous intrathecal baclofen infusion. Ped
Rehabil. 2005;8(3):207-213.
9. Gooch JL, Oberg WA, Grams B, Ward LA, Walker ML. Care
provider assessment of intrathecal baclofen in children. Dev
Med Child Neurol. 2004;46(8):548-552.
10. Parke B, Penn RD, Savoy SM, Corcos D. Functional outcome
following delivery of intrathecal baclofen. Arch Phys
Med Rehabil. 1989;70(1):30-32.
11. Stempien L, Tsai T. Intrathecal baclofen pump use for
spasticity: a clinical survey. Am J Phys Med Rehabil. 2000;79(6):536-541.
12. Azouvi P, Mane M, Theibaut JB, Denys P, Remy-Neris
O, Bussel B. Intrathecal improvement and long-term follow up. Arch
Phys Med Rehabil. 1996;77(1):35-39.
13. 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.
14. Rizzo MA, Hadjimichael OC, Preiningerova J, Vollmer
TL. Prevalence and treatment of spasticity reported by multiple sclerosis
patients. Mult Scler. 2004;10(5):589-595.
15. Guillaume D, Van Havenbergh A, Vloeberghs M, Vidal
J, Roeste G. A clinical study of intrathecal baclofen using a programmable
pump for intractable spasticity. Arch Phys Med Rehabil. 2005;86(11):2165-2171.
16. Middel B, Kuipers-Upmeijer H, Bouma J, et al. Effect
of intrathecal baclofen delivered by an implanted programmable pump on health
related quality of life in patients with severe spasticity. J
Neurol Neurosurg Psychiatry. 1997;63(2):204-209.
17. 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.
18. Koman LA, Paterson Smith B, eds. Management
of Spasticity in Cerebral Palsy: The Role of Intrathecal Baclofen. Towson, MD: Data Trace
Publishing Company; 2005.
19. Lioresal® Intrathecal (baclofen injection) Drug
Package Insert.
ITB Therapy (Intrathecal Baclofen Therapy) is indicated for use in the management of severe spasticity. For spasticity of spinal cord origin, ITB Therapy via an implantable infusion system should be reserved for patients unresponsive to oral baclofen or those who experience intolerable CNS side effects at effective doses. Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long-term intrathecal baclofen therapy.
Important Safety Information for ITB Therapy:
Intrathecal Baclofen Withdrawal: Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure, and death.
Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal. Special attention should be given to patients at risk (e.g., spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen).
This therapy is contraindicated in patients who are hypersensitive to baclofen. Implantation of the infusion system is contraindicated if the patient is of insufficient body size, requires a pump implant deeper than 2.5 cm, or, in the presence of spinal anomalies or active infection.
The most frequent drug adverse events vary by indication but include: hypotonia (34.7%), somnolence (20.9%), headache (10.7%), convulsion (10.0%), dizziness (8.0%), urinary retention (8.0%), nausea (7.3%), and paresthesia (6.7%). Pump system component failures leading to pump stall, or dosing/programming errors may result in clinically significant overdose or underdose. Acute massive overdose may result in coma and may be life threatening.
The most frequent and serious adverse events related to device and implant procedures are catheter dislodgement from the intrathecal space, catheter break/cut, and implant site infection including meningitis. Electromagnetic interference (EMI) and Magnetic resonance imaging (MRI) may cause patient injury, system damage, operational changes to the pump, and changes in flow rate.
Please refer to the full prescribing information and system information for details or call Medtronic at 1-800-328-0810. Rx Only. Lioresal® is a registered trademark of Novartis Pharmaceuticals Corporation.
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