ITB Therapy with Lioresal® Intrathecal (baclofen injection) for the management of severe spasticity uses an implantable infusion system to deliver precise amounts of Lioresal® Intrathecal (baclofen injection) directly to the intrathecal space via a surgically implanted infusion pump and catheter.
Spasticity is an abnormal increase in muscle tone caused by injury of upper motor neuron pathways regulating muscles. Injury or disease of the central nervous system may cause spasticity. Spasticity may be a result of multiple sclerosis (MS), cerebral palsy (CP), stroke, brain injury, or spinal cord injury.
The consensus opinion of one expert panel defined spasticity as disordered sensori-motor control, resulting from upper motor neuro lesion, presenting intermittent or sustained involuntary activation of muscles.1
Severe spasticity can have a distressing effect on function, comfort, and care giving. It may result in musculoskeletal complications, incoordination, loss of function, pain, and permanent muscle shortening or contracture.
Treating severe spasticity may:
For patients with severe spasticity, enhancing their mobility, self-care abilities, and independence are significant achievements. To reach these milestones, effective therapy is necessary. Spasticity can be treated separately from the patient's primary underlying condition.
It can be difficult to effectively control severe spasticity. While physical rehabilitation and oral pharmacologic treatments work for many patients, some patients may not experience enough relief using these treatments alone. In addition, some patients encounter intolerable side effects from systemic medications. Patients with spasticity of spinal origin who are unresponsive to oral baclofen or who experience intolerable central nervous system (CNS) side effects from oral medications may benefit from ITB Therapy. ITB Therapy can significantly decrease severe spasticity2-10 and spasms.3, 8-10 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.
A patient should not receive ITB Therapy if the patient has an active infection, is hypersensitive to baclofen, has a body too small for an implantable pump, requires a pump implant deeper than 2.5 cm, or in the presence of spinal anomalies.
The intrathecal baclofen therapy system consists of a programmable pump, an intrathecal catheter, and an external programmer. The pump is surgically implanted in the patient's abdominal area, the catheter tip is placed in the intrathecal space, and the catheter is connected to the pump. Once implanted, the pump and catheter deliver Lioresal® Intrathecal (baclofen injection) directly to the patient's spinal fluid, where it can act directly in the spinal fluid. The Medtronic SynchroMed™ II infusion pump used for ITB Therapy can be noninvasively programmed to deliver a range of infusion rates, in a variety of dosing patterns.
ITB Therapy delivers baclofen directly into the intrathecal space, thereby bypassing the blood-brain barrier. As a result, only a fraction of the oral dose is needed to produce efficacy while minimizing systemic side effects.11
Three features of ITB Therapy are particularly desirable and important to most patients:
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 withdrawal. Acute massive overdose may result in coma and may be life-threatening.
Baclofen is a structural analog of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), and may exert its effects by stimulation of the GABABreceptor subtype. However, the precise mechanism of action of baclofen as a muscle relaxant and antispasticity agent is not fully understood. Baclofen inhibits both monosynaptic and polysynaptic reflexes at the spinal level, possibly by decreasing excitatory neurotransmitter release from primary afferent terminals, although actions at supraspinal sites may also occur and contribute to its clinical effect.11
In people, as well as in animals, baclofen has been shown to have general CNS depressant properties as indicated by the production of sedation with tolerance, somnolence, ataxia, and respiratory and cardiovascular depression.11
Pandyan AD, Gregoric M, Barnes MP et al. Spasticity: clinical perceptions, neurological realities and meaningful measurement. Disabil Rehabil 2005;27:2–6.
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.
Meythaler JM, Guin-Refroe S, Brunner RC, Hadley MN. Intrathecal baclofen for spastic hypertonia from stroke. Stroke. 2001;32(9):2099-2109.
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.
Gilmartin R. Intrathecal baclofen for management of spastic cerebral palsy: multicenter trial. J Child Neurol. 2000;15(2):71-77.
Penn RD. Intrathecal baclofen for spasticity of spinal origin: seven years of experience. J Neurosurg. 1992;77(2):236-240.
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.
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.
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.
Becker R, Alberti O, Bauer BL. Continuous intrathecal baclofen infusion in severe spasticity after traumatic or hypoxic brain injury. J Neurol 1997; 224(3): 160-166
Lioresal® Intrathecal (baclofen injection) Drug Prescribing Information.
Natale M, Mirone G, Rotondo M, Moraci A. Intrathecal baclofen therapy for severe spasticity: Analysis on a series of 112 consecutive patients and future prospectives. Clin Neurol Neurosurg. 2012;114:321-325.
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;86:2165-2171.
Hoving MA, van Raak EP, Spincemaille GH, Palmans LJ, Becher JG, Vles JS. Efficacy of intrathecal baclofen therapy in children with intractable spastic cerebral palsy: a randomised controlled trial. Eur J Paediatr Neurol. May 2009;13(3):240-246.
Shilt JS, Reeves S, Lai LP, et al. The outcome of intrathecal baclofen treatment on spastic diplegia: Preliminary results with a minimum of two year follow up. J Ped Rehab Med. 2008;255-61.
Common Adverse Reactions
Serious Adverse Reactions
For more information, including BOX WARNING, refer to Lioresal® Intrathecal (baclofen injection) prescribing information, located at www.lioresal.com/prescribinginformation