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Spinal Cord Injury

More than 80% of people with a spinal cord injury (SCI) have spasticity, many of whom experience severe, disabling spasticity.1,2

  • At least 30% of these patients have severe spasticity, and at least 40% of patients report problematic spasticity impacting their activities of daily living and independence.2,3
  • Importantly, the number of patients who experienced spasticity (78%) and required treatment (50%) after 1-year post spinal cord injury compared is higher than at the patients experiencing spasticity soon after spinal cord injury (67% and 37% respectively).2,4

Recognizing Spasticity in Spinal Cord Injury

  • Spasticity occurs more frequently in patients with cervical or thoracic spinal cord injury rather than those with lower thoracic or lumbosacral spinal cord injury.6
  • Increased time after injury and motor incompleteness contribute to increased severity of spasticity. It is usually more significant in persons with specific types of incomplete injuries (persons with ASIA Impairment Scale (AIS) grades B and C).2,6
  • Spasticity can vary greatly in location and degree, and is often worse at night or with fatigue.6
  • Importantly, assessment in spasticity and self-reported spasticity in spinal cord injury can vary greatly, as only about half of patients who report spasticity have measurable spasticity on physical examination; increased time after injury and motor incompleteness contribute to increased severity of spasticity.6

 

Severe spasticity in spinal cord injury has the potential to interfere with activities of daily living, mobility, sleep, or cause depression or pressure sores.7 More than 50% of patients report that spasticity is the most disabling complication of spinal cord injury.8  Spasticity in the legs is common and can be violent enough to propel a patient out of their wheelchair.1 For this reason, when severe spasticity is treated, the goal should be to reach a balance between the beneficial and detrimental effects on quality of life and mobility.7

Unfortunately, as many as 65% of patients have not received antispastic medication, and at least 11% who have received treatments, have failed to respond.4 For individuals with spinal cord injury that affects all of their limbs, treatment with Lioresal® Intrathecal may improve positioning and improved wheelchair tolerance.9 More information about setting personalized treatment goals with Lioresal® Intrathecal can be found in the Screening Trial section of this website.

For spasticity associated with spinal cord injury, ITB Therapy℠ with Lioresal® Intrathecal should be used in patients unresponsive to oral baclofen therapy, or those who experience intolerable CNS side effects from oral baclofen.10 Treatment with Lioresal® Intrathecal (baclofen injection) may increase function with fewer side effects than oral baclofen.

 Severity of Spasticity in Spinal Cord Injury Patients

In the U.S., the number of patients with severe spasticity from a spinal cord injury is

MORE THAN DOUBLE THE TOTAL NUMBER OF MOVIE SCREENS.2,5

 

  1. Elbasiouny SM, Moroz D, Bakr MM, et al. Management of spasticity after spinal cord injury: current techniques and future directions. Neurorehabil Neural Repair. 2010;24(1):23-33.
  2. McGuire JR. Chapter 2: Epidemiology of spasticity in the adult and child. In: Brashear A, Elovic E, eds. Spasticity: Diagnosis and Management. 2nd ed. New York, NY: Demos Medical, 2016.
  3. Saulino M, Ivanhoe CB, McGuire JR, et al. Best practices for intrathecal baclofen therapy: patient selection. Neuromodulation. 2016;19(6):607-615.
  4. Maynard FM, Karunas RS, Waring WP, 3rd. Epidemiology of spasticity following traumatic spinal cord injury. Arch Phys Med Rehabil. 1990;71(8):566-569.
  5. Number of U.S. movie screens. National Association of Theater Owners (NATO) website. https://www.natoonline.org/data/us-movie-screens/. Updated 2016. Accessed September 27, 2017.
  6. Walker HW, Hon AJ, Kirschblum S. Chapter 23: Spasticity due to disease of the spinal cord: pathophysiology, epidemiology, and treatment. In: Brashear A, Elovic E, eds. Spasticity: Diagnosis and Management. 2nd ed. New York, NY: Demos Medical Publishing, LLC, 2016.
  7. Adams MM, Hicks AL. Spasticity after spinal cord injury. Spinal Cord. 2005;43(10):577-586.
  8. Cardenas DD, Dalal K. Spinal cord injury rehabilitation. Phys Med Rehabil Clin N Am. 2014;25(3):xv-xvi.
  9. Boster AL, Bennett SE, Bilsky GS, et al. Best practices for intrathecal baclofen therapy: screening test. Neuromodulation. 2016;19(6):616-622.
  10. Lioresal® Intrathecal (baclofen injection) [prescribing information]. Saol Therapeutics, Roswell, Georgia; January 2019.

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 BOX WARNING, refer to Lioresal® Intrathecal (baclofen injection) prescribing information.