About Severe Spasticity
Living with severe spasticity poses difficult physical challenges. Tight, stiff muscles can get in the way of daily activities. Fortunately, there is a therapy from Medtronic that can minimize severe spasticity in some individuals.
Spasticity is often described as tight, stiff muscles or spasms that may make movement, posture, and balance difficult. It may affect your ability to move one or more of your limbs, or to move one side of your body. Sometimes spasticity is so severe that it gets in the way of daily activities, sleep patterns, and caregiving.
Spasticity is caused by damage or injury to the part of the central nervous system (the brain or spinal cord) that controls voluntary movement. This damage disrupts important signals between the nervous system and muscles, creating an imbalance that increases muscle activity or spasms.
Severe spasticity is associated with the following conditions:
Symptoms of spasticity may include:1
- Increased muscle tone
- Overactive reflexes
- Involuntary movements, which may include spasms (brisk and/or sustained involuntary muscle contraction) and clonus (series of fast involuntary contractions)
- Decreased functional abilities and delayed motor development
- Difficulty with care and hygiene
- Abnormal posture
- Contractures (permanent contraction of the muscle and tendon due to severe persistent stiffness and spasms)
- Bone and joint deformities
Spasticity is typically diagnosed after the onset of a neurological condition. Your doctor will review your medical history and perform a physical evaluation. Your doctor may consider medications you have taken and whether there is a history of neurological or muscular disorders in your family. To confirm the diagnosis, tests can be performed to evaluate arm and leg movements, muscular activity, passive and active range of motion, and ability to perform self-care activities.1
- WebMD Pain Management Health Center. Pain Management: Spasticity. Available at: www.webmd.com. Accessed October 14, 2012.
The Medtronic baclofen pump is part of the Synchromed® Infusion System, which delivers the drug called Lioresal® Intrathecal (baclofen injection) for ITB TherapySM, a treatment for severe spasticity. Please read the following important safety information about ITB Therapy.
IMPORTANT SAFETY INFORMATION FOR ITB THERAPY (Intrathecal Baclofen Therapy)
Please follow your doctor's instruction closely because a sudden stop of intrathecal baclofen therapy can result in serious baclofen withdrawal symptoms such as high fever, changed mental status, muscle stiffness, and in rare cases may result in loss of function of many vital organs and death. It is very important that your doctor be called right away if you experience any of the above symptoms.
It is important for you to keep your scheduled refill visits so you don't run out of medication (baclofen) and to know the early symptoms of baclofen withdrawal. Some patients are at more risk than others for baclofen withdrawal; speak with your doctor about this.
People who suffer from severe spasticity resulting from cerebral palsy, multiple sclerosis, stroke, brain injury, or spinal cord injury may be candidates for ITB Therapy. If you have spasticity due to spinal cord injury or multiple sclerosis, you may be considered for ITB Therapy if oral baclofen has not controlled your spasticity or has resulted in serious side effects that you cannot accept. If you suffered a brain injury due to trauma you must wait until one year after the injury to be considered for ITB Therapy. A trial of ITB Therapy will help to show if ITB Therapy can help you. You should not receive ITB Therapy if you have an infection, are allergic to baclofen, or your body size is too small for the implantable pump.
The implanted pump and catheter (tube that delivers the drug from the pump to the fluid around the spinal cord) are placed under the skin during a surgery. Some complications that you may experience with the surgery include infection, meningitis (infection of the lining of the brain and central nervous system), spinal fluid leak, paralysis, headache, swelling, bleeding, and bruising.
The most common and/or serious drug-related side effects of ITB Therapy include loose muscles, sleepiness, upset stomach, vomiting, headaches, and dizziness. Failure of the pump placed under your skin may cause symptoms due to overdose (receiving too much) or underdose (receiving too little) of intrathecal baclofen. The signs and symptoms of overdose include drowsiness, lightheadedness, dizziness, respiratory depression (difficulty breathing), hypothermia (lower than normal body temperature), seizures, loss of consciousness, and coma. Once the infusion system (the pump and the catheter) is implanted, possible complications include unintended movement of the catheter or pump within the body or breakdown of the skin over the pump. The catheter could leak, tear, kink, or become disconnected from the pump, resulting in underdose or no baclofen infusion. Symptoms of underdose include an increase or return in spasticity, itching, low blood pressure, lightheadedness, and tingling sensation. These symptoms are often early signs of baclofen withdrawal. The pump could stop because the battery has run out or because of a problem with one or more of its inner parts. The pump will sound an alarm when the pump needs to be filled with baclofen, replaced, or if there is a problem with the pump. You or your caregiver should always inform any healthcare personnel that you have an implanted infusion system before any medical or diagnostic procedure such as MRI or diathermy.
For more information, please read the Lioresal® Intrathecal (baclofen injection) Full Prescribing Information and the SynchroMed Infusion System Information.
This therapy is not for everyone. Please contact your doctor. A prescription is required.
Lioresal® is a registered trademark of Medtronic, Inc.
USA Rx Only Rev 0913
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Information on this site should not be used as a substitute for talking with your doctor. Always talk with your doctor about diagnosis and treatment information.
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