The Spasticity Management Team

The best treatment of spasticity usually includes an active patient or advocate and caregivers working with several healthcare professionals from various medical backgrounds. Members of this team may include one or more of the following people.

Neurologist: A neurologist is a medical doctor trained in disorders of the nervous system. The neurologist may diagnose the neurologic problem; prescribe treatments, including medications and physical and occupational therapy; and refer the patient for surgical evaluation if necessary. The neurologist may also inject the chemodenervation treatments (see the section on treatment that follows).

Physiatrist: A physiatrist is a medical doctor who specializes in physical medicine and rehabilitation. The physiatrist may design the rehabilitation program, working with other team members to maximize the patient’s function and minimize the disabling aspects of the neurologic injury. The physiatrist may also prescribe medications and administer chemodenervation treatments.

Physical therapist: A physical therapist is a healthcare professional who is responsible for the physical aspects of treatment. The physical therapist may perform or direct another person to perform the exercises that are necessary to assist in maintaining the range of motion of limbs affected by spasticity. The physical therapist may also apply and fit braces, splints, or casts that may be prescribed by the physiatrist or other treating physician. In addition, the physical therapist may direct training to improve the patient’s ability to walk or move and may instruct patients and caregivers on how to position affected arms and legs to help reduce spasticity. A physical therapist often works closely with an occupational therapist to design changes in the home and equipment that might be necessary to accommodate the patient’s needs.

Occupational therapist: An occupational therapist is a healthcare professional who specializes in adaptation of the physical environment to meet the patient's needs. The occupational therapist may teach modifications for dressing, feeding, and grooming to the patient and caregiver. This therapist may also offer expertise on adaptive devices such as wheelchairs and bath equipment and may advise on home and workplace modifications to increase accessibility and ease of use. The occupational therapist is usually the medical professional who advises the school on issues such as seating, writing, and use of facilities.

Neurosurgeon: A neurosurgeon is a medical doctor who is specially trained to perform surgical procedures related to the nervous system. For example, when a patient with severe spasticity has a positive response to a screening test for ITB™ Therapy (intrathecal baclofen bolus) and is then recommended to receive continuous intrathecal baclofen, the neurosurgeon may implant the baclofen delivery pump.

Neurosurgeons may also perform an operation to destroy selected sensory nerves at their entry point into the spinal cord (selective dorsal rhizotomy) when other treatments cannot offer adequate spasticity relief. When a patient requires exposure of a target nerve for chemodenervation, the neurosurgeon may be the physician who performs that operation; a neurologist or physiatrist then usually performs the chemodenervation.

Orthopedic surgeon: An orthopedic surgeon is a medical doctor who is specially trained to perform operations related to bones, joints, muscles, and surrounding connective tissue. These types of procedures may help to reduce or correct contractures that lead to abnormal positioning of joints. Orthopedic operations often involve reconstruction or revision of tendons and bones. The orthopedic surgeon may also assist with the fitting of braces and assessing growth and development, as well as implant the baclofen delivery pump and perform chemodenervation.

Important Safety Information Related to ITB Therapy and the SynchroMed II System

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.

IMPORTANT SAFETY INFORMATION ON ITB THERAPY
Please follow your doctor's instruction closely because a sudden stop of intrathecal baclofen therapy can result in serious illness (baclofen withdrawal symptoms) such as high fever, changed mental status, muscle rigidity, and in rare cases multiple organ-system failure 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 understand the early symptoms of baclofen withdrawal. Some patients are at more risk than others for baclofen withdrawal; consult with your doctor.

People who suffer from severe spasticity resulting from cerebral palsy, multiple sclerosis, stroke, traumatic brain injury, or spinal cord injury may be a candidate for ITB Therapy. If you have spasticity due to spinal cord injury or multiple sclerosis you must first fail oral baclofen. If you have experienced a traumatic brain injury you must first wait 1 year after the injury to be considered for ITB Therapy. A screening test will help show if you will respond to the intrathecal baclofen. You should not receive ITB Therapy if you have an infection, are allergic to baclofen, or your body size is too small to hold the implantable pump.

The implanted pump and catheter are surgically placed beneath the skin. Surgical complications that you may experience include infection, meningitis, 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. Pump failure may cause overdose or underdose of intrathecal baclofen. The signs and symptoms of overdose include drowsiness, lightheadedness, respiratory depression (difficulty breathing), seizures, loss of consciousness, and coma. Once the infusion system is implanted, device complications include catheter or pump moving within the body or eroding through the skin. The catheter could leak, tear, kink, or become disconnected, resulting in underdose or no baclofen infusion. Symptoms of underdose include increase or return in spasticity, itching, low blood pressure, lightheadedness, and tingling sensation. These symptoms are often early indications of baclofen withdrawal. The pump could stop because the battery has run out or because of component failure. 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. 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 Novartis Pharmaceuticals Corporation.