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Efficacy

 

ITB Therapy℠ with Lioresal® Intrathecal (baclofen injection) has a well-established efficacy profile for severe spasticity. It is approved to treat severe spasticity of both cerebral and spinal origins.1

Before implantation of the SynchroMed® II infusion system, patients must show a positive response to Lioresal® Intrathecal in a screening trial.

Efficacy for Severe Spasticity of Spinal Origin

A controlled clinical investigation (Penn et al. 1989) in patients with severe spasticity due to multiple sclerosis (MS) and spinal cord injury (SCI) demonstrated the efficacy and safety of ITB Therapy℠ with Lioresal® Intrathecal and served as the basis for US Food and Drug Administration (FDA) approval for severe spasticity of spinal origin spasticity in 1992. This study compared the effects of either a single intrathecal dose or a 3-day infusion of Lioresal® Intrathecal to placebo, demonstrating the superiority of Lioresal® Intrathecal in change from baseline in the Ashworth Scale for spasticity and the change from baseline in the frequency of spasms.1

This study was supported by additional studies, including studies in patients with spasticity from cerebral origin, pediatric patients, screening trials, and open-label, long-term (up to 7 years) extension trials (see Penn 1992; Coffey et al. 1993).

 

Efficacy for Severe Spasticity of Cerebral Origin

The efficacy of Lioresal® Intrathecal was investigated in 3 controlled clinical trials: 2 trials enrolled patients with cerebral palsy and 1 enrolled patients with spasticity due to previous brain injury or stroke. These trials were the basis of FDA approval for spasticity of cerebral origin in 1996, as they demonstrated significant reduction in spasticity. Note that there is no safety or efficacy data in children under 4 years of age or in patients less than 1 year after traumatic brain injury.1

The first study, a randomized controlled crossover trial of 51 patients with cerebral palsy, and demonstrated statistically significant superiority of Lioresal® Intrathecal compared to placebo in reducing spasticity as measured by the Ashworth Scale (see Gilmartin et al. 2000). This study was conducted after Albright et al. published data demonstrating efficacy of ITB Therapy℠ with Lioresal® Intrathecal in both pediatric and adult patients with cerebral palsy.

A second crossover study was conducted in 11 patients with spasticity arising from brain injury. Despite the small sample size, the study yielded a nearly significant test statistic (P=0.066) and provided directionally favorable results (see Meythaler et al. 1996). The last study, however, did not provide data that could be reliably analyzed.1

Supportive data and long-term efficacy of ITB Therapy℠ with Lioresal® Intrathecal were demonstrated in additional trials.

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%). Dosing and programming errors may result in clinically significant overdose or withdrawal. Acute massive overdose may result in coma and may be life threatening. Drowsiness has been reported in patients on Lioresal® Intrathecal. Patients should be cautioned regarding the operation of automobiles or other dangerous machinery and activities made hazardous by decreased alertness. Patients should also be cautioned that the central nervous system depressant effects of Lioresal® Intrathecal may be additive to those of alcohol and other CNS depressants. Seizures have been reported during overdose and with withdrawal from Lioresal® Intrathecal as well as in patients maintained on therapeutic doses of Lioresal® Intrathecal. Fatalities have been reported with Lioresal® Intrathecal use. 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.

  1. Lioresal® Intrathecal (baclofen injection) for intrathecal injection [prescribing information]. Saol Therapeutics, Roswell, Georgia; January 2019.
  2. Penn RD, Savoy SM, Corcos D, et al. Intrathecal baclofen for severe spinal spasticity. N Engl J Med. 1989;320(23):1517-1521.
  3. Coffey RJ, Cahill D, Steers W, et al. Intrathecal baclofen for intractable spasticity of spinal origin: results of a long-term multicenter study. J Neurosurg. 1993;78(2):226-232.
  4. Penn RD. Intrathecal baclofen for spasticity of spinal origin: seven years of experience. J Neurosurg. 1992;77(2):236-240.
  5. 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.
  6. 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.
  7. Draulans N, Vermeersch K, Degraeuwe B, et al. Intrathecal baclofen in multiple sclerosis and spinal cord injury: complications and long-term dosage evolution. Clin Rehabil. 2013;27(12):1137-1143.
  8. Gianino JM, York MM, Paice JA, Shott S. Quality of life: effect of reduced spasticity from intrathecal baclofen. J Neurosci Nurs. 1998;30(1):47-54.
  9. Guglielmino A, Sorbello M, Fazzio S, et al. Continuous intrathecal baclofen administration by a fully implantable electronic pump for severe spasticity treatment: our experience. Minerva Anestesiol. 2006;72(10):807-820.
  10. Khan AA, Birks-Agnew I, Bullock P, Rushton D. Clinical outcome and complications of intrathecal baclofen pump in multiple sclerosis patients: a retrospective study. NeuroRehabilitation. 2010;27(2):117-120.
  11. 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.
  12. 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.
  13. Ordia JI, Fischer E, Adamski E, Spatz EL. Chronic intrathecal delivery of baclofen by a programmable pump for the treatment of severe spasticity. J Neurosurg. 1996;85(3):452-457.
  14. 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.
  15. Vender JR, Hughes M, Hughes BD, Hester S, Holsenback S, Rosson B. Intrathecal baclofen therapy and multiple sclerosis: outcomes and patient satisfaction. Neurosurg Focus. 2006;21(2):e6.
  16. Vidal J, Fenollosa P, Martin E, et al. Safety and efficacy of intrathecal baclofen infusion by implantable pump for the treatment of severe spinal spasticity: a spanish multicenter study. Neuromodulation. 2000;3(4):175-182.
  17. Zahavi A, Geertzen JH, Middel B, Staal M, Rietman JS. Long term effect (more than five years) of intrathecal baclofen on impairment, disability, and quality of life in patients with severe spasticity of spinal origin. J Neurol Neurosurg Psychiatry. 2004;75(11):1553-1557.
  18. 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.
  19. Albright AL, Cervi A, Singletary J. Intrathecal baclofen for spasticity in cerebral palsy. JAMA. 1991;265(11):1418-1422.
  20. Meythaler JM, DeVivo MJ, Hadley M. Prospective study on the use of bolus intrathecal baclofen for spastic hypertonia due to acquired brain injury. Arch Phys Med Rehabil. 1996;77(5):461-466.
  21. 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.
  22. 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.
  23. Borowski A, Shah SA, Littleton AG, Dabney KW, Miller F. Baclofen pump implantation and spinal fusion in children: techniques and complications. Spine (Phila Pa 1976). 2008;33(18):1995-2000.
  24. Borowski A, Littleton AG, Borkhuu B, et al. Complications of intrathecal baclofen pump therapy in pediatric patients. J Pediatr Orthop. 2010;30(1):76-81.
  25. Dario A, Di Stefano MG, Grossi A, Casagrande F, Bono G. Long-term intrathecal Baclofen infusion in supraspinal spasticity of adulthood. Acta Neurol Scand. 2002;105(2):83-87.
  26. Francisco GE, 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.
  27. Ghosh D, Mainali G, Khera J, Luciano M. Complications of intrathecal baclofen pumps in children: experience from a tertiary care center. Pediatr Neurosurg. 2013;49(3):138-144.
  28. Hoving MA, van Raak EP, Spincemaille GH, et al. Efficacy of intrathecal baclofen therapy in children with intractable spastic cerebral palsy: a randomised controlled trial. Eur J Paediatr Neurol. 2009;13(3):240-246.
  29. Hoving MA, van Raak EP, Spincemaille GH, et al. Safety and one-year efficacy of intrathecal baclofen therapy in children with intractable spastic cerebral palsy. Eur J Paediatr Neurol. 2009;13(3):247-256.
  30. 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.
  31. 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.
  32. Meythaler JM, McCary A, Hadley MN. Prospective assessment of continuous intrathecal infusion of baclofen for spasticity caused by acquired brain injury: a preliminary report. J Neurosurg. 1997;87(3):415-419.
  33. 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.
  34. 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.
  35. Morton RE, Gray N, Vloeberghs M. Controlled study of the effects of continuous intrathecal baclofen infusion in non-ambulant children with cerebral palsy. Dev Med Child Neurol. 2011;53(8):736-741.
  36. Motta F, Buonaguro V, Stignani C. The use of intrathecal baclofen pump implants in children and adolescents: safety and complications in 200 consecutive cases. J Neurosurg. 2007;107(1 Suppl):32-35.
  37. Motta F, Antonello CE, Stignani C. Intrathecal baclofen and motor function in cerebral palsy. Dev Med Child Neurol. 2011;53(5):443-448.
  38. Ordia JI, Fischer E, Adamski E, Spatz EL. Continuous intrathecal baclofen infusion delivered by a programmable pump for the treatment of severe spasticity following traumatic brain injury. Neuromodulation. 2002;5(2):103-107.
  39. Ramstad K, Jahnsen R, Lofterod B, Skjeldal OH. Continuous intrathecal baclofen therapy in children with cerebral palsy - when does improvement emerge? Acta Paediatr. 2010;99(11):1661-1665.
  40. Schiess MC, Oh IJ, Stimming EF, et al. Prospective 12-month study of intrathecal baclofen therapy for poststroke spastic upper and lower extremity motor control and functional improvement. Neuromodulation. 2011;14(1):38-45; discussion 45.
  41. 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 Pediatr Rehabil Med. 2008;1(3):255-261.
  42. Vles GF, Soudant DL, Hoving MA, et al. Long-term follow-up on continuous intrathecal Baclofen therapy in non-ambulant children with intractable spastic Cerebral Palsy. Eur J Paediatr Neurol. 2013;17(6):639-644.

ITB Therapy℠ with Lioresal® Intrathecal

Penn et al. conducted a double-blind, randomized, crossover study of ITB Therapy℠ with Lioresal® Intrathecal from 1986-1988 in 20 adults with severe spasticity due to MS (n=10) or SCI (n=10). They demonstrated significantly decreased muscle tone in all 20 patients (according to the Ashworth scale for rigidity [mean ± standard deviation (SD) from 4.0±1.0 to 1.2±0.4; P<0.0001]), and spasms were significantly decreased in 18 of 19 (95%) patients (mean ± SD for spasm frequency decreased from 3.3±1.2 to 0.4±0.8; P<0.0005).2

In an open-label extension following the double-blind period, the reduction in spasticity was maintained for at least 2 years with continuous intrathecal administration.2

There was no drowniness, confusion, or infections reported in this study. One pump failed and 2 catheters dislodged and had to be replaced. One pump was moved due to pain at the implantation site.2

Efficacy of Lioresal® Intrathecal

Efficacy of Lioresal® Intrathecal was also demonstrated in a second randomized, double-blind, placebo-controlled screening protocol trial conducted from 1988-1990 in 93 adult patients with severe spasticity due to MS (n=31), SCI (n=59), or other spinal pathology (n=3). In total, 88 (94.6%) patients responded to the screening test dose, 2.2% of these patients experienced side effects and did not continue the study, and 75% underwent pump implantation for long-term ITB Therapy℠ with Lioresal® Intrathecal. Patients were followed for a mean of 19 months (range 5-41) or until death (3 cases) or study withdrawal (2 cases). No deaths or new permanent neurological deficits occurred as a result of surgery or ITB therapy. Rigidity was reduced from a mean preoperative Ashworth scale score of 3.9 to a mean postoperative score of 1.7. Muscle spasms were reduced from a mean preoperative score of 3.1 (on a 4-point scale) to a mean postoperative score of 1.0. Reductions remained stable over time.3

In this study, 1 patient withdrew due to a lae surgical complication (pump pocket infection), and a second patient received an intrathecal baclofen overdosage because of human error in programming the pump. One patinet had the surgical repair of the pump pocket due to erosion and a second had replacement of the pump following mechanical failure. Catheter malfunctions occurred in 18 patients (22 malfunctions); all were easily repaired. Drug-related side effects occurred in 11 patients (3 during screening and 8 during chronic intrathecal administration), which included respiratory depression, hypotension, temporary weakness, hypertension, and drowsiness. All were reversed with proper treatment.3

Lioresal® Intrathecal Screening Dose4

In this study, 66 patients with severe spasticity of spinal cord origin (33 cases of MS, 32 cases spinal trauma, 1 case of lateral sclerosis) who had failed oral antispastic medication were screened with ITB Therapy℠ with Lioresal® Intrathecal; 64 patients responded to a screening dose and 62 decided to have a pump implanted. In other words, ITB therapy reduced spasms and spasticity in 97% of patients. The average treatment period with ITB Therapy℠ with Lioresal® Intrathecal was 30 months, and the longest was 84 months.4

In this study, 2 infections occurred; both were treated successfully with antibiotics.No deaths occured that were realted to baclofen treatment or pump implantation. The most frequent side effects of intrathecal baclofen were drowsiness (22/62 cases), dizziness (10/62), blurred vision (10/62), and slurred speech (6/62). Episodes of nausea, orthostatic hypotension, nystagmus, confusion, memory decrease, or dysmetria were rare ([symbol <=]3 of cases of each. One patient developed grand mal seizures after several months of intrathecal therapy and had to be place on anticonvulsant medications. No patients discontinued therapy because of side effects.4

Lioresal® Intrathecal (baclofen injection) Screening Dose18

This study examined a screening dose of Lioresal® Intrathecal in a randomized, double-blind, placebo-controlled phase followed by a phase 2, open-label, long-term continuous infusion trial for patients with a positive response to the screening dose. Patients with cerebral palsy (n=51; 35 with quadriplegia, 12 with diplegia, and 4 with paraplegia; 44 received implants and joined the open-label, long-term study) demonstrated clinically significant relief of spasticity in the lower extremities (decrease in the average Ashworth Scale score from 3.64 at baseline (n=44) to 2.33 at 6 months (n=42), 2.15 at 12 months (n=40), and 1.90 at 39 months (n=7). There was a trend toward improvement in upper limb spasticity over time as well.18

In this study, 42/51 patients reported adverse events, the most common of which were hypotonia, seizures )no new onset), somnolence, nausea or vomiting, increased salivations, and constipations. In addition, 59% of patients experienced procedural or system-related events.18

Lioresal® Intrathecal (baclofen injection) TBI Bolus Injection20

In this study, 11 patients with severe hypertonia affecting their activities of daily living following traumatic brain injury (from motor vehicle crashes, gunshot wounds, and an anoxic episode) received ITB bolus injection in a randomized, double-blind, placebo-controlled trial. All but 1 patient responded to the injection of Lioresal® Intrathecal, as demonstrated in their decrease in Ashworth Scale scores. The average lower extremity Ashworth Scale score decreased 2.0 points from 4.2 (SD ±0.8) before treatment to 2.2 (SD ±0.6) 4 hours after treatment (P=0.0033). The average spasm score for the lower extremities decreased 2.1 points from 3.1 (SD ±1.0) before treatment to 1.0 (SD +0.7) 4 hours after treatment (P=0.0032). Finally, the average lower extremity reflex score decreased 2.3 points from 3.3 (SD ±0.5) before treatment to 1.0 (SD +1.3) 4 hours after treatment (P=0.0033).20

There were no untoward side effects or complications associated with intrathecal baclofen treatment in this study. Complications from pump placement were minor, and spinal headaches that lasted up to 1 week after pump placement were noted in 5 patients. One patient experienced a catheter dislodgement.20

Select Studies

Select Studies of ITB Therapy℠ With Lioresal® Intrathecal (baclofen injection) in Patients With Severe Spasticity of Cerebral Origin, Including Cerebral Palsy, Brain Injury, and Stroke

Author Year Journal Title PMID
Albright et al.19 1991 JAMA

Intrathecal baclofen for spasticity in cerebral palsy

 1999883
Albright et al.21 2003 J Neurosurg

Long-term intrathecal baclofen therapy for severe spasticity of cerebral origin

 12593613
Becker et al.22 1997 J Neurol

Continuous intrathecal baclofen infusion in severe spasticity after traumatic or hypoxic brain injury

 9050956
Borowski et al.23 2008 Spine

Baclofen pump implantation and spinal fusion in children: techniques and complications

 18708932
Borowski et al.24 2010 J Pediatr Orthop

Complications of intrathecal baclofen pump therapy in pediatric patients

 20032747
Dario et al.25 2002 Acta Neurol Scand

Long-term intrathecal Baclofen infusion in supraspinal spasticity of adulthood

 11903116
Francisco et al.26 2003

Arch Phys Med Rehabil

Improvement in walking speed in poststroke spastic hemiplegia after intrathecal baclofen therapy: a preliminary study

 12917859
Ghosh et al.27 2013 Pediatr Neurosurg

Complications of intrathecal baclofen pumps in children: experience from a tertiary care center

 24577095
Hoving et al.28 2009

Eur J Paediatr Neurol

Efficacy of intrathecal baclofen therapy in children with intractable spastic cerebral palsy: a randomised controlled trial

 18595749
Hoving et al.29 2009

Eur J Paediatr Neurol

Safety and one-year efficacy of intrathecal baclofen therapy in children with intractable spastic cerebral palsy

 18590974
Ivanhoe et al.30 2006

Arch Phys Med Rehabil

Intrathecal baclofen management of poststroke spastic hypertonia: implications for function and quality of life

 17084128
Krach et al.31 2006 Pediatr Rehabil

Satisfaction of individuals treated long-term with continuous infusion of intrathecal baclofen by implanted programmable pump

 17050399
Meythaler et al.32 1997 J Neurosurg

Prospective assessment of continuous intrathecal infusion of baclofen for spasticity caused by acquired brain injury: a preliminary report

 9285608
Meythaler et al.33 1999

Arch Phys Med Rehabil

Long-term continuously infused intrathecal baclofen for spastic-dystonic hypertonia in traumatic brain injury: 1-year experience

 9915366
Meythaler et al.34 2001 Stroke

Intrathecal baclofen for spastic hypertonia from stroke

 11546903
Morton et al.35 2011

Dev Med Child Neurol

Controlled study of the effects of continuous intrathecal baclofen infusion in non-ambulant children with cerebral palsy

 21707598
Motta et al.36 2007

Dev Med Child Neurol

Intrathecal baclofen and motor function in cerebral palsy

 21480874
Motta et al.37 2011 J Neurosurg

The use of intrathecal baclofen pump implants in children and adolescents: safety and complications in 200 consecutive cases

 17644918
Ordia et al.38 2002 Neuromodulation

Continuous intrathecal baclofen infusion delivered by a programmable pump for the treatment of severe spasticity following traumatic brain injury

 22151849
Ramstad et al.39 2010 Acta Paediatr

Continuous intrathecal baclofen therapy in children with cerebral palsy - when does improvement emerge?

 19912148
Schiess et al.40 2011 Neuromodulation

Prospective 12-month study of intrathecal baclofen therapy for poststroke spastic upper and lower extremity motor control and functional improvement

 21992161
Shilt et al.41 2008

J Pediatr Rehabil Med

The outcome of intrathecal baclofen treatment on spastic diplegia: Preliminary results with a minimum of two year follow-up

 21791773
Vles et al.42 2013

Eur J Paediatr Neurol

Long-term follow-up on continuous intrathecal Baclofen therapy in non-ambulant children with intractable spastic Cerebral Palsy

 23871360

Modified Ashworth Scale (MAS)10

The MAS is a subjective scale that measures passive activity. A score of 0 to 4 is assigned by the examiner based on the amount of increased resistance perceived while moving the patient’s joint through its available range of motion. The MAS is an attempt to strengthen the Ashworth Scale, first published in 1964, with a more reliable scale, particularly when evaluating the wrist and elbow. Importantly, the Ashworth Scale and MAS are well known, easy to perform, and have a history of use for evaluating spasticity and management outcomes in both clinical trials and practice.10

Ashworth Scale10 Modified Ashworth Scale10
Score Description Score Description
0 No increase in muscle tone 0 No increase in muscle tone
1

Slight increase in muscle tone manifested at end of range of motion

 1

Slight increase in muscle tone manifested by a catch and release at end of range of motion
1+

Slight increase in muscle tone, manifested by a catch followed by minimal resistance throughout the remainder (less than ¼) of the range of motion
2

More marked increase in tone through most of the range of motion but joint easily moved

 2

More marked increase in tone through most of the range of motion but joint easily moved
3

Considerable increase in muscle tone; passive movement is difficult

 3

Considerable increase in muscle tone; passive movement is difficult
4

Affected part is rigid in flexion or extension

 4

Affected part is rigid in flexion or extension

Adapted from Reference 10: Khan AA, Birks-Agnew I, Bullock P, Rushton D. Clinical outcome and complications of intrathecal baclofen pump in multiple sclerosis patients: a retrospective study. NeuroRehabilitation. 2010;27(2):117-120.

Select Studies

Select Studies of ITB Therapy℠ With Lioresal® Intrathecal (baclofen injection) in Patients With Severe Spasticity of Spinal Origin, Including SCI and MS

Author Year Journal Title PMID
Azouvi et al.5 1996

Arch Phys Med Rehabil

ITB administration for control of severe spasticity: functional improvement and long-term follow-up

 8554471
Coffey et al.3 1993 J Neurosurg

ITB for intractable spasticity of spinal origin: results of a long-term multicenter study

 8421205
Dario et al.6 2001 Funct Neurol

Functional improvement in patients with severe spinal spasticity treated with chronic ITB infusion

 11853321
Draulans et al.7 2013 Clin Rehab

Intrathecal baclofen in multiple sclerosis and spinal cord injury: complications and long-term dosage evolution

 23858524
Gianino et al.8 1998 J Neurosci Nurs

Quality of life: effect of reduced spasticity from intrathecal baclofen

 9604822
Guglielmino et al.9 2006 Minerva Anestesiol

Continuous intrathecal baclofen administration by a fully implantable electronic pump for severe spasticity treatment: our experience.

 17006418
Khan et al.10 2010 NeuroRehabilitation

Clinical outcome and complications of intrathecal baclofen pump in multiple sclerosis patients: a retrospective study.

 20871140
Loubser et al.11 1991 Paraplegia

Continuous infusion of intrathecal baclofen: long-term effects on spasticity in spinal cord injury

 2023770
Middel et al.12 1997 J Neurol Neurosurg

Effect of intrathecal baclofen delivered by an implanted programmable pump on health related quality of life in patients with severe spasticity

 9285459
Ordia et al.13 1996 J Neurosurg

Chronic intrathecal delivery of baclofen by a programmable pump for the treatment of severe spasticity

 8751632
Ordia et al.14 2002 Neuromodulation

Continuous intrathecal baclofen infusion by a programmable pump in 131 consecutive patients with severe spasticity of spinal origin

 22151777
Penn et al.2 1989 N Engl J Med

Intrathecal baclofen for severe spinal spasticity

 2657424
Penn RD4 1992 J Neurosurg

Intrathecal baclofen for spasticity of spinal origin: seven years of experience

 1625011
Vender et al.15 2006 Neurosurg Focus

Intrathecal baclofen therapy and multiple sclerosis: outcomes and patient satisfaction

 16918227
Vidal et al.16 2000 Neuromodulation

Safety and efficacy of intrathecal baclofen infusion by implantable pump for the treatment of severe spinal spasticity: a Spanish multicenter study

 22151522
Zahavi et al.17 2004

J Neurol Neurosurg Psychiatry

Long term effect (more than five years) of intrathecal baclofen on impairment, disability, and quality of life in patients with severe spasticity of spinal origin

 15489386

Important Safety Information for Lioresal® Intrathecal (baclofen injection)

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 apparent risk (e.g. spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen). Consult the technical manual of the implantable infusion system for additional postimplant clinician and patient information (see WARNINGS).

Indications and Usage

Contraindications

Select Warnings and Precautions

Adverse Reactions

Common Adverse Reactions

Serious Adverse Reactions

Postmarketing Experience

Use in Specific Populations

For more information, including BOXED WARNING, refer to Lioresal® Intrathecal (baclofen injection) prescribing information.