Spasticity

Special Patient Considerations and FAQ

Patient Selection

Since spasticity is a function of many dynamic and complex factors, its assessment can be quite difficult. The Ashworth Scale and Spasm Frequency Scale appear to be clinically useful measures of spasticity of spinal origin. A severity of 3 on the Ashworth and 2 on the Spasm for at least 12 months are reasonable criteria for ITB Therapy consideration. Candidates must have disabling spasticity unresponsive to conservative pharmacotherpay or intolerable side effects at therapeutic doses. Pharmacotherapy should include, but need not be limited to, a trial of oral baclofen.

Tailoring ITB Therapy

While addressing clinical and functional goals, the baclofen dose is titrated to a dose that relieves disabling spasticity and muscle spasms. However, some degree of muscle tone may be required to:

• assist in the support of circulatory function
• possibly prevent deep vein thrombosis
• optimize daily living activities and ease of care

Striking a balance between the patient's condition, their functional goals, and physiological demands is an ongoing challenge.

The Intrathecal Baclofen™ FAQ (Frequently Asked Questions)

ITB Therapy Goals

• What are the treatment goals?
• Are the clinical goals the same for each patient?

Exclusion from ITB Therapy

• Are patients excluded by complications associated with immobility?
• Does a patient's size or age prevent the use of ITB Therapy?
• Is infection a contraindication to ITB Therapy?
• Is hypersensitivity to oral baclofen a contraindication to ITB Therapy?

SPECIAL PATIENTS

• Can patients with a seizure history receive ITB Therapy?
• Is the presence of other devices important?
• Is the treatment effective for upper extremity spasticity?
• Do patients become tolerant to ITB Therapy?

 
ITB Therapy Goals

What are the treatment goals?
Since ITB Therapy may be appropriate for a broad range of disability, from ambulatory to vegetative states, treatment and functional goals must be individualized, clearly understood and agreed upon by the patient, family, caregivers, and care-provider team before starting treatment. Expectations that are not stated or are unrealistic often lead to disappointment, depression and interpretations of treatment failure.

Are the clinical goals the same for each patient?
Not really. The major clinical goal is to establish muscle tone that optimizes the patient's function with the fewest adverse side effects. The ability to provide graduated control of spasticity using ITB Therapy is essential for some patients to bear weight, maintain erect posture, and walk. In non-ambulatory patients with severe tetraplegia, the goal may be to maximize the reduction of spasticity.

Are patients excluded by complications associated with immobility?
In general, patients with contractures, hip dislocations, bony deformities, UTI, respiratory distress, reduced appetite, and weight loss may benefit from spasticity reduction with ITB Therapy.

Does a patient's size or age prevent the use of ITB Therapy?
Generally, no. The patient's body mass must be able to support the pump. Children as young as 4 years are allowed to receive ITB Therapy. A smaller pump is available when required.

 
Exclusion from ITB Therapy

Is infection a contraindication to ITB Therapy?
Infection represents an explicit contraindication to ITB Therapy screening and pump implantation. Once the infection is eradicated, the patient can undergo the procedure. Once a pump is in place, however, any infection must be managed properly, with heightened surveillance for the potential of seeding the hardware (catheter or pump). In addition, patients are advised to contact the physician responsible for ITB Therapy when they are ill.

Is hypersensitivity to oral baclofen common?
No. Although hypersensitivity to oral baclofen is another explicit contraindication to ITB Therapy, such reactions are very unusual.

 
Special Patients

Can patients with a seizure history receive ITB Therapy?
Yes. A history of seizures is not a contraindication to ITB Therapy. Although the risks and benefits must be carefully weighed, the balance of evidence suggests that ITB Therapy has little to no impact on the frequency of seizures in patients managed for epilepsy prior to ITB Therapy.

Is the presence of other devices important?
It depends. The presence of a ventriculoperitoneal shunt is not a contraindication to ITB Therapy, although the dose may need to be lowered due to slower CSF circulation from the thecal sac. Gastrostomy in not a contraindication to pump implantation, since it can be implanted away from the gastrostomy site. Compatibility with other implantable programmable medical devices (e.g., pacemakers, spinal cord stimulators) has yet to be determined.

Is the treatment effective for upper extremity spasticity?
Yes. ITB Therapy is effective in reducing both upper and lower extremity spasticity.

Do patients develop a tolerance to intrathecal baclofen?
Infrequently. Approximately 5 percent of patients become refractory to increasing doses during long-term ITB Therapy. Occasionally the problem can be managed by a "drug holiday"—gradual reduction of the dose over a 2-week period, using other methods of spasticity management, and then returning to the initial continuous infusion dose.