ALTRU HEALTH SYSTEM Grand Forks, ND STANDARD GUIDELINE Title: BACLOFEN PUMP PROGRAM (INTRATHECAL) Issued by: Physical Medicine and Outpatient Therapy Date: 6/99 Reviewed: 2/17 Revision: 2/11 Page: 1 of 5 I. Indications for Intrathecal Baclofen Pump Placement A. Spasticity or spasms which interfere with function, personal cares, or cause discomfort. B. Spasticity which is refractory to oral antispasmodics or unacceptable side effects at effective dose. C. Patient and family must be committed to follow-up treatment and refills of pump. D. Patient, family, and medical professionals must have clearly defined goals. E. Potential candidates may be patients with neurological involvement related to Multiple Sclerosis (MS), Cerebral Palsy (CP), or other diagnoses with cerebral or spinal cord origin such as Spinal Cord injury (SCI), or Traumatic Brain Injury (TBI) with indications as listed above. II. Exclusion Criteria A. Alcohol or drug abuse. B. Presence of active infection. C. Pregnant or not using birth control, or a nursing mother. D. Contraindicated for patients who have demonstrated hypersensitivity to oral Baclofen. III. Process: If possible, the same physical therapist should follow through with a particular patient's care/treatment, especially the screening, test dose(s), and inpatient program. Ongoing PT services following the inpatient phase can be coordinated as deemed appropriate by the physical therapist and/or team members. A. Upon physician referral, potential candidates may be scheduled for outpatient evaluation with PT, OT, and/or Speech Therapy. The screening would be performed prior to a test dose or implantation of a pump. 1. A physician referral is required for this visit. 2. Assessment in PT includes the Modified Ashworth Scale for grading spasticity, ROM, frequency of spasms, and functional mobility skills. B. Patients are frequently scheduled for a test dose prior to implantation of a pump. This is typically performed via lumbar puncture and patients are admitted to Altru Hospital acute care. 1. Physical Therapy must do a pre-dose assessment of spasticity using the Modified Ashworth Scale as well as assess adductor tone. Functional skill areas can be filled in on the form according to level observed during outpatient screening or, if no screening was done, may be evaluated at this time. If a screening was performed, you do not need to repeat the functional items unless requested by the physician or there is a significant delay between the pre-screening evaluation and the test dose. 1
2. Post-dose assessments must occur at 1 hour and 4 hours post bolus (or according to physician preference). At 1 hour, bedside assessment is performed including spasticity using the Modified Ashworth Scale and level of adductor tone as assessed by PROM. The patient must remain in bed; therefore functional skills are not assessed. During the 4 hour assessment, the patient can be out of bed to perform functional skills assessment with physician approval if no spinal headache is present. Check with nursing staff. Nursing staff will also be monitoring closely for any adverse reactions to the medication. 3. To qualify for pump implantation, there should be a decrease of 1-2 points in the average L/E score using the Modified Ashworth Scale. C. If the test dose is successful and the physician feels it is appropriate, the patient may be scheduled for surgery for pump implantation. D. If the test dose is not successful, the patient can possibly undergo up to 2 additional trials on consecutive days with increasing dosages. PT pre/post assessments will need to be performed with each trial. 1. If the same physical therapist is unable to complete all three trials, the same physical therapist must at least perform all three assessments within each trial day. 2. Documentation must be completed for each trial day. E. Following a pump implantation surgery: 1. The patient may be supine for 24 up to 72 hours or, if no spinal headache is present, may be allowed to get up sooner. 2. PT will perform a Modified Ashworth Scale assessment approximately 24 hours after pump implantation. IV. Treatment: Use the following as a guideline for treatment; however, each patient must be evaluated individually according to their needs. A. Assessment and observations regarding function and tone level should be relayed to the physician on a daily basis initially following pump implantation via documentation in the patient s medical record. Tone level should be assessed using the Modified Ashworth Scale, including the same motions as were assessed during previous phases. B. Ongoing communication with the physician regarding tone level and function should occur as needed throughout the treatment program to assist in dose regulation. Frequency of communication can be adjusted according to physician preference and patient needs. C. Postoperative through Week 1 1. Initially following surgery, focus will be on intensive stretching. 2. Adhere to post-surgical precautions as listed in Section VI unless otherwise indicated by the physician. 3. Education with patient and family: a. Feelings of "weakness" or "heaviness" of limbs initially that should improve with physical therapy treatment and strengthening. b. Changes in "center of gravity." c. Changes in movement based on absence/decrease of spasticity. d. Precautions regarding function/location of pump as well as during movement. 4. Discuss/review goals of patient and family as appropriate. 2
5. Comprehensive evaluation should be performed including: a. Subjective history, surgical date, referring physicians, home environment, etc. b. Upper and lower extremity ROM and strength. c. Full sensory evaluation including sharp/dull, proprioception, light touch, and vibration. d. Mat mobility/transfers. e. Ambulation. f. Stairs. g. Cognitive status. h. Any other pertinent information. i. Goals, including patient goals. j. Treatment plan. 6. Assessment of equipment needs, especially if changes are needed in wheelchair seating and/or support. 7. Coordinate with other disciplines such as OT for ADL training, etc. as appropriate. 8. Discharge Planning: a. Following pump placement, patients will be discharged from acute care to an appropriate setting, which may include home, rehab, or skilled nursing facility. b. Regardless of the discharge setting, each patient will likely require ongoing PT services via either outpatient, Home Health, or restorative PT services in a skilled nursing facility. Arrangements must be made as appropriate, including referrals, home program, and/or proper education with the patient and family or other caregivers. D. Weeks 2 through weeks 4-6 1. Adhere to post surgical precautions as listed in Section VI unless otherwise indicated by the physician. 2. Continue treatment in the appropriate setting regarding functional skills, equipment, exercise, etc. a. Therapeutic exercise: strengthen weakened muscle groups and stretch shortened muscles. Activities to facilitate balance and equilibrium reactions as well as develop new movement patterns related to changes in spasticity should be implemented. b. Transfer and gait training, bed mobility skills, progression to balance and coordination exercise if appropriate. c. Therapeutic ultrasound, heat or electrical stimulation may be used but not directly over the pump site. d. Continue to evaluate equipment needs to improve function as well as provide optimal seating, positioning, and support. E. Weeks 4 through 8: Transition 1. Treatment continues with frequency and duration dependent on the patient's progress toward goals. Begin transition to increase patient's responsibility for PT activities. F. Weeks 6-8 3
1. Multidisciplinary follow-up evaluations may be requested by the physician. If this is requested, PT will reassess the Modified Ashworth Scale for grading spasticity, ROM, frequency of spasms, functional mobility skills, and other items if appropriate. G. Ongoing 1. A 6-month recheck may occur. If this occurs, PT will reassess spasticity, ROM, spasms, and functional mobility. 2. Adjust home programs and consult with the patient as necessary. 3. Also, be aware that the patient will be scheduled with the physician for pump refill approximately every 4-12 weeks depending on the individual's dosage. V. Outcome of Intrathecal Baclofen Pump Placement A. Relieve spasticity or spasms in order to: 1. increase function. 2. increase ease of personal cares/hygiene. 3. decrease discomfort. VI. Precautions A. Be aware that the pump will release programmed amounts of medication. The amount may be continuous over 24 hours or may vary throughout the day according to the patient's individual needs. B. Watch for any unusual reactions and report any of the following symptoms of overdose of Baclofen to the physician immediately. Symptoms of overdose which may result in coma and/or respiratory arrest/support include: - Drowsiness or lethargy - Increased weakness - Dizziness - Seizures - Headache - Nausea/vomiting C. Also watch for and report to the physician any symptoms of too little drug which may include return of spasticity and/or muscle spasms. This may indicate dislodgment, occlusion, kinking, or leaking of catheter; component failure; or battery depletion (batteries typically last 4-5 years and require a new pump to be placed when depleted). D. Watch for and report any signs of infection due to surgical procedure such as swelling, redness, or pain near incision. E. Avoid excessive trunk movement including bending, twisting, overhead reaching or excessive trunk flexion beyond 45 degrees (either lower extremities on trunk or trunk on lower extremities) to avoid catheter dislodgment. Hip flexion to 90 degrees is allowed in supine or sitting. F. No use of ultrasound, heat or electrical stimulation over or near the pump site. G. The patient will use an abdominal binder to reduce swelling and decrease possibility of hematoma or seroma. H. Also be aware of the location of the pump so that you don't place gait belts, etc. over this area post-operatively. Modified Ashworth Scale 4
0 No increase in muscle tone. 1 Slight increase in muscle tone, manifested by a catch and release, or by minimal resistance at the end of the ROM when the affected part(s) is moved in flexion or extension. 2 Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder(less than half) of the ROM. 3 More marked increase in muscle tone through most of ROM, but affected part(s) easily moved. 4 Considerable increase in muscle tone, passive movement difficult. 5 Affected part(s) rigid in flexion or extension. Motions evaluated include hip flexion, knee flexion, hip abduction, ankle dorsiflexion, elbow flexion and extension, and wrist flexion and extension. However, other motions can be included if appropriate to the individual patient. Reference: Intrathecal Baclofen Therapy: Guidelines for the Physical Therapist. Medtronic, Inc. 1996. 5