Intrathecal baclofen infusion ibi is an effective treatment for spasticity secondary to cerebral palsy. We aimed to identify and describe complications of intrathecal baclofen pump as well as to report avoidance and management of complications. Baclofen, a gammaaminobutyric acid gaba agonist, works to inhibit the excitatory activity at the spinal reflexes. Functional benefits and costbenefit analysis of continuous intrathecal baclofen infusion for the management of severe spasticity. Background and purpose we sought to determine whether continuous intrathecal delivery of baclofen can effectively decrease spastic hypertonia due to stroke methods stroke patients with 6 months of intractable spasticity were screened via a randomized, doubleblind, placebocontrolled crossover design of either intrathecal normal saline or 50. Avoid abrupt discontinuation of intrathecal baclofen therapy. Continuous intrathecal infusion of baclofen in patients. Intrathecal baclofen itb is an invasive treatment for spasticity and spasms. Drowsiness, nausea, headache, muscle weakness, lightheadedness and return of pretreatment spasticity can be. Background intrathecal baclofen itb infusion has been increasingly used in patients with intractable spasticity. These benefits must be weighed against the risks of internal pump and catheter placement in patients considering intrathecal baclofen therapy. This enables accurate evaluation of the response by you and the team 4 hours later, when it reaches maximum.
Intrathecal baclofen has not been previously evaluated for the treatment of the disabling hypertonia associated with hereditary spastic paraparesis. Pdf intrathecal baclofen for treatment of spasticity. It can be given by a health care professional in a clinic or hospital setting. Lioresal intrathecal baclofen injection is available in singleuse ampules of 10 mg20 ml 500 mcgml or 10 mg5 ml 2000 mcgml packaged in a refill kit for intrathecal administration. What makes itb therapy different from oral medications is the delivery of the medication to the site where it is used the fluidfilled area surrounding the spinal cord called the intrathecal space. Listing a study does not mean it has been evaluated by the u. As with all medications there are possible side effects of intrathecal baclofen, these include possible changes to the bladder positive or negative, bowel or sexual function. Use of continuous intrathecal baclofen in hereditary.
Intrathecal baclofen therapy in patients with multiple. An intrathecal delivery system, which provides the baclofen right to the target site in. Volume 30, issue 6, novemberdecember 2019, pages 288293. Abrupt discontinuation of intrathecal baclofen, regardless of cause, has resulted in severe reactions including high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multisystem organ failure, and death.
Despite the nearly 2 decades of widespread clinical use, this intervention presents many challenges to even experienced clinicians. Intrathecal baclofen pump for muscle spasticity treatment. Pdf download for limitations of intrathecal baclofen for spastic. Intrathecal baclofen for dystonia treatment during. Intrathecal baclofen in the treatment of adult spasticity in. The intrathecal baclofen dosage stabilizes in the long term, indicating that longterm tolerance, defined as progressive diminution of the susceptibility to the effects of a drug, is not present. Intrathecal baclofen pump has been used effectively with increasing frequency in patients with severe spasticity, particularly for those patients who are unresponsive to conservative pharmacotherapy or develop intolerable side effects at therapeutic doses of oral baclofen. Pdf intrathecal baclofen in hereditary spastic paraparesis. Intrathecal baclofen intratheecal backlofen is a treatment used for children who have conditions that cause spasticity and dystonia, which means that their muscles are tighter than they should be. Intrathecal it baclofen drug distribution itb the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Baclofen is a medicine that helps the muscles to relax.
Pdf continuous intrathecal baclofen application itb through an intracorporeal pump system is widely used in. Intrathecal baclofen itb therapy is an accepted treatment modality for spasticity and dystonia. Safety study of 3 mgml baclofen injection intrathecal using a programmable pump the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Baclofen is an antispasmodic drug and muscle relaxant indicated for treating spasticity. Clinical considerations article pdf available in archives of hellenic medicine 321. This medicine is for injection into the space around the spinal cord. Intrathecal baclofen is baclofen that is given into the space around the spinal cord. The pump is surgically implanted in the patients abdominal area, the catheter tip is placed in the intrathecal space, and the catheter is connected to the pump.
Intrathecal baclofen therapy how is intrathecal baclofen. In this study, we present our institutional experience with itb therapy, emphasizing complication avoidance and lessons learned. Remember anything is possible if you put your mind to it. Concurrent plasma concentrations of baclofen during intrathecal administration are. Intrathecal baclofen as a treatment for spasticity. An overview of intrathecal baclofen management and. Baclofen gablofen, lioresal is a medication that treats stiff muscles and spasms, a condition called spasticity, that can happen to people with multiple sclerosis ms and other nerve diseases. An intrathecal baclofen itb pump is a device thats surgically implanted to deliver baclofen medication directly into spinal fluid.
Intrathecal baclofen therapy about the therapy medtronic. Safety study of 3 mgml baclofen injection intrathecal. It may also be used for hiccups and muscle spasms near the end of life. Intrathecal baclofen itb therapy aims to reduce spasticity and provide functional control.
Limitations of intrathecal baclofen for spastic hemiparesis following. A disorder characterized by velocitydependant increase in the tonic stretch reflex muscle tone with exaggerated tendon jerks resulting from hyperexcitability of the stretch reflexes the stretch reflex arc nerve fibers from various tract converge and synapse in the anterior horn, maintaining segmental muscle tone by modulating the stretch reflex arc, which is basically a negative feedback. Intrathecal baclofen injection is cleared through the lymphatic system csf turnover versus being metabolized or reabsorbed into the vascular system. Unlimited viewing of the articlechapter pdf and any associated supplements and figures. Talk to your pediatrician regarding the use of this medicine in children.
All patients responded, and were enrolled in a randomized, placebo controlled, crossover trial in which the treatment periods consisted of 3 days of continuous delivery of lioresal intrathecal vs. Each milliliter of lioresal intrathecal contains baclofen. You can also watch this video on youtube with or without closedcaptioning for a complete list of our videos, click here. Intrathecal baclofen itb has become the first choice in the management of. Once an intrathecal baclofen pump is in place and your dose is stabilised, the aim is to reduce and possibly stop any other antispasticity medication you are taking. Patients can also have a pump implanted into their back for a continuous infusion. Make sure you know how you react to baclofen before you drive, use machines, or do anything else that could be dangerous if you are not alert, wellcoordinated, and able to see well. Prior to pump implantation and initiation of chronic infusion of lioresal intrathecal baclofen injection, patients must demonstrate a positive clinical response to a lioresal intrathecal bolus dose administered intrathecally in a screening trial. Intrathecal baclofen for spastic hypertonia from stroke. Use of continuous intrathecal baclofen in hereditary spastic paraplegia jessie khera,1 nadine e andrew,1 dominique a cadilhac,1,2 tara purvis,1 michael c fahey,3,4 hyam barry rawicki1 1department of medicine, faculty of medicine, nursing and health sciences, monash university, clayton, 2stroke division, florey institute of neurosciences and mental health, heidelberg, 3department of paediatrics. Intrathecal baclofen administration for control of severe spinal. After watching, please complete our twominute survey. It was a great success and i was told eventually i would be able to walk with one cane and shorter leg braces.
It used to be thought of as a last resort but more recently both health professionals and people with ms are realising it can help to keep people mobile and well without the side effects often experienced by oral medications. This study demonstrates that chronic intrathecal baclofen infusion is a safe and effective form of treatment of intractable spasticity in patients with spinal cord injury. It is taken by mouth or by delivery into the spinal canal common side effects include sleepiness, weakness, and dizziness. Several complications related to itb have been described, including mechanical malfunctions, infections, cerebrospinal fluid fistula, and baclofen withdrawal or overdose. Not only bupivacaine or lidocaine and not only anesthesia or analgesia joseph eldor, md the concept that a barrier exists between the blood and the brain was first formulated nearly a century ago. There is considerable reduction in the risk of infection in view of the fact that interrogation and programming of the implanted programmed pumps is noninvasive. Pump fill and drug delivery can be started intraoperatively, with monitoring for at least.
A clinical study of intrathecal baclofen using a programmable pump for intractable spasticity. Baclofen has not been linked to rare instances of mild, selflimited, clinically apparent liver injury. Baclofen, sold under the brand name lioresal among others, is a medication used to treat muscle spasticity such as from a spinal cord injury or multiple sclerosis. Subsequent animal studies demonstrated that intrathecal opioids produce powerful and highly selective analgesia 2. Colored dyes injected into the circulation of laboratory animals stained all tissues except the brain. Pdf intrathecal baclofen administration for the treatment of. The drug infusion system delivers the medication in small, precisely controlled doses throughout the day. Intrathecal baclofen administration for the treatment of spasticity. Baclofen is a monocarboxylic acid that is butanoic acid substituted by an amino group at position 4 and a 4chlorophenyl. Baclofen is a centrally acting muscle relaxant commonly prescribed for spasticity in patients with multiple sclerosis. The intrathecal baclofen therapy system consists of a programmable pump, an intrathecal catheter, and an external programmer. Lioresal intrathecal is intended for use by the intrathecal route in single bolus test doses via spinal catheter or lumbar puncture and, for chronic use, only in implantable pumps approved by the fda specifically for the administration of lioresal intrathecal into the intrathecal space.
The following is the available commercial preparations of baclofen. Intrathecal it baclofen drug distribution full text. Medications such as baclofen, bupivacaine, clonidine, morphine, or ziconotide may be delivered in this manner to minimize the side effects often associated with the higher doses used in oral or. Intrathecal administration of baclofen is a wellestablished technique for modulating hypertonia secondary to upper motor neuron pathology. Intrathecal baclofen itb has become the standard of care for the treatment of severe spasticity of both spinal and cortical origin 15. To assess longterm efficacy and functional ben efits of intrathecal baclofen for severe spinal spasticity. Longterm continuously infused intrathecal baclofen for spastic. Intrathecal baclofen may cause dizziness, drowsiness, false sense of wellbeing, lightheadedness, vision problems, or clumsiness or unsteadiness in some people. Itb therapy helps reduce spasticity by allowing muscles to relaxits a treatment to relieve spasms, reduce abnormal movements and improve motor function. An intrathecal pump is a medical device used to deliver via an intrathecal catheter medications directly into the space between the spinal cord and the protective sheath surrounding the spinal cord. Baclofen baclofen dose, indications, adverse effects. Lioresal intrathecal is a sterile, pyrogenfree, isotonic solution free of antioxidants, preservatives or other potentially neurotoxic additives indicated only for intrathecal administration. Pdf imaging evaluation of intrathecal baclofen pump. The net result is a very low or undetectable plasma baclofen concentration during itb therapy.
Spasticity is caused by an imbalance between signals that inhibit or stimulate the spinal cord. Spasticity is a movement disorder that can occur in conditions which affect the brain or the spinal cord, such as multiple sclerosis, stroke, cerebral palsy, spinal cord injury, or brain injury. Baclofen pump implantation and intrathecal administration is currently the most efficient method for treating spasticity of cerebral and. Intrathecal baclofen injection 50, 75, and 100 micrograms in an openlabel screening test. Novel epidural baclofen infusion trial for intractable spasticity with. A report on pregnancy in a quadriplegic patient treated with a high dose of mcg24h continuous intrathecal baclofen infusion using an implanted drug. Two patients previously implanted with intrathecal baclofen itb pumps for management of intractable spasticity due to multiple sclerosis ms were referred to our center for ongoing management of their. An overview of intrathecal baclofen management and troubleshooting aacpdm 2014 instructional course 31 introduction5 minuteskrach o itbvery effective intervention for tone reduction but requires. Intrathecal baclofen pump baclofen is a muscle relaxant medicine commonly used to decrease spasticity related to multiple sclerosis, spinal cord injuries, or other neurological diseases. For screening, lioresal intrathecal is available in a singleuse ampule of 0. The screening trial employs lioresal intrathecal at a concentration of 50 mcgml. Intrathecal baclofen delivered by an implanted catheter and pump system provides good relief of spasticity while overcoming these limitations. Procedure and devicerelated complications of intrathecal baclofen administration for management of adult muscle hypertonia.