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After reading the article you should be able to:

1. Recognize the signs and symptoms of spasticity.
2. Describe different phases of spasticity and their treatments.
3. Develop a plan of nursing care for the patient being treated with intrathecal baclofen (ITB).

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By ELLEN BARKER, RN, MSN, APN, CNRN

ELLEN BARKER, a clinical nurse specialist, is president of Neuroscience Nursing Consultants in Greenville, DE. She is the author of the textbook Neuroscience Nursing: A Spectrum of Care and a member of the RNeditorial board. She has been a member of the speakers’ bureau for Medtronic. EDITOR: Kathleen A. Moore, RN, BS. She has no financial relationships to disclose.

Patients with severe spasticity from neurological disease, or brain or spinal cord injury, may be candidates for intrathecal baclofen therapy, a treatment that may significantly improve their quality of life.

Consider the following scenarios: A 34-year-old mother of two with multiple sclerosis (MS) develops spasticity that's so severe her current dose of oral baclofen (Lioresal) is no longer effective. When the dose is increased, she becomes too drowsy to care for her children.

An 18-year-old man recovering from severe traumatic brain injury spends most of his day in a wheelchair, because spasticity keeps him from walking more than short distances, even with help. Increasing his oral antispasticity medication isn't an option, because doing so would further impair his cognitive function.

A school-age boy with cerebral palsy (CP) has difficulty walking and playing because of stiff, painful muscles and spasms. He becomes sleepy when the dose of his antispasticity medication is increased.

A woman recovering from a stroke experiences severe stiffness of her arm and leg, which interferes with her rehabilitation regimen. She has tried several drugs for spasticity, but their side effects prevent her from participating fully in her exercise program.

Each of these individuals suffers from severe spasticity caused by a central nervous system (CNS), or neurological, disorder. And in each case, the prescribed treatment is either ineffective or has intolerable side effects.

An alternative for patients like these is intrathecal baclofen (ITB) therapy. When delivered intrathecally—into the space surrounding the spinal cord—by way of a surgically implanted pump, antispasticity medication can be administered at the precise dose the patient requires, with flexibility in the rate, dose, and pattern of administration.

With ITB therapy, patients with severe spasticity need less medication—and therefore experience fewer side effects—than they would if they took the drug orally. This translates to decreased spasticity, better muscle function, and improved quality of life. Here, I'll share what I know about ITB therapy, as well as spasticity in general, so that you can pass this information on to patients whose spasticity may require more aggressive management.

Recognizing the signs of spasticity

Spasticity is muscle tightness or stiffness from increased muscle tone caused by repeated or continuous contraction of the muscle. It usually involves the flexors of the arms and the extensors of the legs. The increased muscle tone can interfere with the patient's function, comfort, and sleep. Without treatment, spasticity can lead to contracture, or abnormal shortening of the muscle tissue, causing permanent deformity.¹

We don't fully understand what causes spasticity, but we do know that the occurrence is marked by the interruption of descending inhibitory impulses from the brain to the spinal cord. The condition is a component of the "upper motor neuron syndrome," a term that refers to the abnormal body movements that occur when the motor pathways extending from the cerebral cortex to the spinal cord (the descending corticospinal tracts) are damaged by trauma or disease.

In other words, spasticity develops when there's injury to the areas of the CNS that regulate muscle function.² Knowing this, it's important that nurses assess for spasticity when caring for patients with neurological conditions like congenital CP; acquired brain and spinal cord injury; vascular disorders, such as stroke; and chronic progressive diseases, like MS.

When collecting a history, consider spasticity if a patient reports tripping, falling, long bone fractures, problems with ambulation, or difficulty performing the activities of daily living (ADLs), such as eating, bathing, dressing, or grooming. Caregivers of patients with spasticity may tell you they have trouble getting the patient out of bed or transferring him from bed to chair; that urinary catheterization poses problems because of the inability to properly position the patient's legs; or that bathing, dressing, and repositioning him takes an inordinate amount of time.

During the physical examination, suspect spasticity if you note:

• increased muscle tone, with stiffness of the fingers, arms, or legs;
• increased resistance to passive stretch or exaggerated tendon jerks during the assessment of range of motion;
• clonus, or involuntary rhythmic contraction and relaxation of the muscles that appears as "jerking";
• painful spasms when you flex or extend the patient's limbs;
• rigidity, or pronounced muscle tone when the extremity is at rest; or
• loss of functional limb control.

In patients with spasticity, you may note hyperexcitable reflexes, and a pathological Babinski's reflex—upgoing toes, or extension of the great toe with fanning of the other toes—when you stroke the patient's sole. This abnormal reflex indicates upper motor neuron disease or damage to the corticospinal tract above the first lumbar vertebra.¹

Evaluating spasticity, determining treatment

If you suspect your patient has spasticity, evaluate it further using a tool such as the Modified Ashworth Scale, which classifies spasticity within a six-point system, from no increase in tone to rigidity in flexion and extension, based on resistance of muscles as they're moved by the examiner.^3,4 Determining the severity of spasticity will help guide treatment.

Spasticity can be progressive and, therefore, categorized by phases. In Phase 1, the condition may respond to heat application, range of motion or stretching exercises, and the prevention or elimination of noxious triggers, such as constipation, pressure ulcers, urinary tract infection, and kidney stones that can temporarily exacerbate it.

In Phase 2, spasticity has worsened, is accompanied by pain or discomfort, and interferes with function, gait, or ADLs; it requires physical and occupational therapy, assistive devices, analgesics, and oral antispasticity medication.

Progression to Phase 3 means spasticity is severe and requires more comprehensive management. If oral medication has failed or is causing intolerable or undesirable side effects, the patient should be evaluated for ITB therapy.

Treating spasticity with intrathecal baclofen

The most commonly used antispasticity drug, oral baclofen (Lioresal) was approved by the U.S. Food and Drug Administration for the treatment of spasticity in 1977. A GABA agonist, it "replaces" the inhibitory neurotransmitter that is deficient. As with many other drugs, patients can develop tolerance to baclofen, in which case the drug loses its effectiveness unless the dose is increased. For many patients, higher doses mean undesirable, and sometimes intolerable, side effects,⁵ such as drowsiness and impaired cognition.

Although the manufacturer's maximum recommended dose is 80 mg per day, some individuals take up to 240 mg per day without side effects becoming an issue. Others, however, can't tolerate doses much higher than the routine 5 mg PO three times a day. Similar problems can occur with other antispasticity drugs. For information on other agents used to treat spasticity, see the table on the facing page.

The FDA approved intrathecal baclofen for spasticity of spinal origin in 1992, and for spasticity of cerebral origin in 1996. The medication is delivered by way of an implanted programmable pump, as shown in the photos on pages 24 and 28. In 1999 alone, surgeons implanted an estimated 5,000 pumps for intrathecal drug delivery. Controlled clinical studies have demonstrated that ITB therapy, though not without risk, is an effective and relatively safe treatment for severe spasticity of spinal or cerebral origin, even in children.^6-9 Of course, prior authorization and proper coding with private carriers, Medicaid, and Medicare are key factors in procuring the appropriate level of reimbursement for ITB therapy.

During pump implantation, and after

Candidates for ITB are usually age 4 or older and have severe spasticity that interferes with function, ADLs, or care by family or caregivers; intolerable side effects from oral therapy; sufficient body size and subcutaneous tissue to support the implanted pump; a positive response to a screening dose of ITB; the support of family or a caregiver; and the ability and willingness to keep follow-up appointments for reassessment and pump refills. Patients who have an active infection, impaired renal function, or hypersensitivity to baclofen are not candidates for ITB.

The screening process can take six to eight hours, or all day. If the response to the test dose is positive, the treating team and nurse meet with the patient and family to ensure that they fully understand the treatment's goals, benefits, potential complications, and compliance requirements. If all goes well, the surgery is scheduled.

Prior to the procedure, a physician or other trained clinician injects preservative-free baclofen into the pump, which is battery-operated and easily adjustable with an external programmer. Then, with the patient under general anesthesia, a surgeon implants the pump subcutaneously or subfascially in the abdomen, near the waistline. He connects it to a small, flexible, silicone catheter inserted between the vertebrae, threaded into the intrathecal space, and tunneled subcutaneously to the pump site. The surgery may take one to three hours, depending on the patient's pre-surgical medical condition.

What to expect after the procedure

If you're caring for the patient postoperatively, have him lie flat for a prescribed period of time, as determined by the surgeon, and administer analgesics for discomfort at the surgical site. If you need to transfer the patient, be sure to maintain his spine in proper alignment.

The patient will have two incisional sites: one in the abdomen and one in the lower back. Assess sites for drainage; serous or pink-tinged fluid could indicate a CSF leak, which occurs in 15% of patients.¹⁰ Another late possible complication of the ITB therapy is seroma, an internal collection of serous fluid, which occurs in nearly a quarter of cases.¹¹

The hospital stay for pump implantation can range from 23 hours or less to three to four days. Patients who go home after several hours are given instructions to return at a designated date and time, usually two or so days after the surgery, for dressing removal and pump activation. The surgeon removes the sutures or staples at two to three weeks postop.

Discharge instructions will vary, depending on the patient. Typically, patients may shower, but not bathe. Activity restriction may be necessary for up to eight weeks postop, depending on the patient's lifestyle.

Some patients will need three to five days of acute rehabilitation for the initiation of ITB therapy, for dose titration, and to address the muscle weakness that the change in treatment could unmask. Rehabilitation may include physical therapy for muscle strengthening, gait and transfer training, and evaluation for changes in assistive devices and equipment.

The first postop visit—and beyond

Whether a patient is discharged home or to rehab, he'll continue to take his oral antispasticity medication until the pump is turned on—typically at the first postop office visit. Once the device begins to deliver small, precise amounts of the drug at a set rate into the spinal column (where it mixes with cerebrospinal fluid), the oral medication is tapered. Weaning may continue for several months while the physician or clinician adjusts the intrathecal dose.

Patients follow up at one- to six-month intervals for pump refills, which take about 30 minutes. Clinicians or specially trained nurses may refill or reprogram the pump, under physician supervision.

Frequently, nurses are responsible for the follow-up care of patients receiving ITB. Such care includes monitoring the therapeutic response, checking vital signs, reviewing all medications, inquiring about the patient's general health, answering questions, and watching for adverse reactions, such as allergies, respiratory distress, severe weakness, the sudden return of spasticity, overdose, and withdrawal. In particular, RNs play an important role in educating patients on recognizing early warning signs and managing symptoms of withdrawal as well as potential overdose.

If overdose is suspected, the patient needs to get to the nearest ED right away, where a physician can withdraw the remaining baclofen from the pump and provide treatment for the current condition. Signs and symptoms of baclofen overdose include hypotonia or severe muscle weakness, vomiting, blurred vision, and decreased level of consciousness.¹² Another critical symptom to watch for is respiratory depression, which can lead to bradycardia, hypotension, and death if respiration is not supported. To reverse baclofen's effects, patients may need physostigmine (Antilirium) or flumazenil (Romazicon).

The implanted pump typically lasts five to seven years, at which point it's replaced. The pump will alarm, or "beep," when it needs to be refilled, the battery is low, or the device isn't delivering the baclofen properly. However, there is no sensor to alert patients to a catheter malfunction, so care must be taken to evaluate its status regularly. If the pump alarms, patients must notify their physicians or nurses immediately. Timely refills are important, as an empty reservoir can lead to baclofen withdrawal. Signs and symptoms of withdrawal include spasticity, itching, tingling, lightheadedness, hypotension, and seizures.

Severe withdrawal is a medical emergency. It progresses from a dramatic increase in spasticity, spontaneous clonus, diaphoresis, and pruritis without a rash, to tachycardia, tachypnea, fever, delirium, seizures, rhabdomyolysis, multi-organ system failure, and death.¹³

Patients on ITB therapy should wear a Medic- Alert bracelet and should have a management plan for signs and symptoms of baclofen withdrawal, such as keeping oral baclofen, cyproheptadine (Periactin tablets), and benzodiazepines handy, along with providers' numbers to call to be seen immediately. They should also carry a medical device identification card, so that they can avoid security metal-device checkpoints that could affect the pump. Magnetic resonance imaging affects the pump, too; it temporarily suspends baclofen delivery, which should then resume once the procedure is through. Patients with an ITB pump should avoid physical trauma as well, as it could damage the catheter and interrupt the delivery of baclofen.

Helping patients lead more normal lives

A 10-year review of 50 ITB recipients found that all 50 reached their short-term treatment goals within three months of pump implantation. These goals included increased comfort, decreased pain, enhanced sleep, increased ease of care and transfers, increased independence in ADL, and improved communication and ambulation.¹¹ Nearly 80% of the patients reported that they achieved their long-term objectives as well, such as returning to work, ambulation without assistive devices, and discontinuation of wheelchair use.¹¹

Nurses shouldn't give up when a patient's spasticity progresses and disability worsens. We can identify neurological patients with, or at risk for, severe spasticity, and refer them to specialists who can offer them proven therapeutic options, such as ITB. In doing so, we can spare patients unnecessary suffering and improve their quality of life.

REFERENCES

1. Schwartzman, R. J. (2006). Neurologic examination (1st ed.). Maiden, MA: Blackwell Publishing.

2. Barker, E. (2008). Neuroscience nursing: A spectrum of care (3rd ed.). St. Louis, MO: Mosby/Elsevier.

3. Bohannon, R. W., & Smith, M. B. (1987). Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther, 76, 2006.

4. "Table 11-1. Clinical scale for spastic hypertonia (Modified Ashworth Scale)." In Cuccurullo, S. J. (Ed.) Physical medicine and rehabilitation board review. 2004. www.ncbi.nlm.nih .gov/books/bv.fcgi?indexed=google&rid=physmedrehab.table.13577 (27 Mar. 2008).

5. Salerno, E. (Ed.) (2005). Mosby's 2005 drug consult for nurses. St. Louis, MO: Elsevier/Mosby.

6. Albright, A. L., Barron, W. B, et al. (1993). Continuous intrathecal baclofen infusion for spasticity of cerebral origin. JAMA, 279(20), 2475.

7. Albright A. L., Gilmartin, R., Swift, D. et al. (2003). Long-term intrathecal baclofen therapy for severe spasticity of cerebral origin. J Neurosurg, 98, 291.

8. Loubser, P. G., Narayan, R. K. et al. (1991). Continuous infusion of intrathecal baclofen: Long-term effects on spasticity in spinal cord injury. Paraplegia, 19(1), 48.

9. Parke, B., Penn, R. D., et al. (1989). Functional outcome after delivery of intrathecal baclofen. Arch Phys Med Rehab, 70(1), 30.

10. Ordia, J. I., Fisher, E. et al. (2002). Continuous intrathecal baclofen infusion by a programmable pump in 131 consecutive patients with severe spasticity of spinal origin. Neuromodulation, 5(1),16.

11. Rawlins, P. K. (2004). Intrathecal baclofen therapy over 10 years. J Neurosci Nurs, 36(6), 322.

12. Shirley, K. W., Kothare, S., Platt, J. H. Jr., Adirim, T. A. (2006). Intrathecal baclofen overdose and withdrawal. Pediatr Emerg Care, 22(4), 258.

13. Coffey R. J., & Ridgely, P. M. (2001). Abrupt intrathecal baclofen withdrawal: Management of potentially life-threatening sequelae. Neuromodulation, 4(4), 142.

Treating spasticity

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Sources: 1. Salerno, E. (Ed.). (2005). Mosby's 2005 drug consult for nurses. St. Louis: Mosby/Elsevier. 2. Wilson, B. A., Shannon, M. T., & Stang, C. L. (2007). Nurse's drug guide 2007. Upper Saddle River, NJ: Pearson/Prentice Hall.