Michael Saulino

Intrathecal Baclofen Therapy: An Update

Intrathecal administration of baclofen is a well‐established technique for modulating hypertonia secondary to upper motor neuron pathology. Despite the nearly 2 decades of widespread clinical use, this intervention presents many challenges to even experienced clinicians. The purpose of this clinical review is to describe some of the intricacies and subtleties of this treatment strategy. This narrative provides an overview of 3 topics: (1) an alternative methodology for intrathecal baclofen trials; (2) an algorithmic approach to troubleshooting intrathecal delivery systems; and (3) the utility of neurophysiologic assessments within various phases of intrathecal baclofen therapy.

The Polyanalgesic Consensus Conference (PACC): Recommendations for Trialing of Intrathecal Drug Delivery Infusion Therapy

Intrathecal (IT) drug infusion is an appropriate and necessary tool in the algorithm to treat refractory cancer and noncancer pain. The decision‐making steps/methodology for selecting appropriate patients for implanted targeted drug delivery systems is controversial and complicated. Therefore, a consensus on best practices for determining appropriate use of IT drug infusion may involve testing/trialing this therapy before implantation.

Best Practices for Intrathecal Baclofen Therapy: Troubleshooting.

Troubleshooting helps optimize intrathecal baclofen (ITB) therapy in cases of underdose, overdose, and infection.

Best Practices for Intrathecal Baclofen Therapy: Dosing and Long‐Term Management

Intrathecal baclofen (ITB) therapy aims to reduce spasticity and provide functional control.

Best Practices for Intrathecal Baclofen Therapy: Screening Test

Intrathecal baclofen (ITB) screening assesses response to a test dose of ITB on spasticity and function and identifies adverse reactions.

Medical cost impact of intrathecal baclofen therapy for severe spasticity.

To evaluate the economic effects of intrathecal baclofen (ITB) for patients with severe spasticity based on costs of care before and after implantation of an intrathecal drug delivery system.

Efficacy of intraoperative vancomycin powder use in intrathecal baclofen pump implantation procedures: single institutional series in a high risk population.

We aimed to assess the efficacy of intraoperative vancomycin powder in intrathecal baclofen pump placement patients, a high risk population. A retrospective review was conducted using prospectively collected data at an academic tertiary care unit. The neurosurgical adult patient population was queried for all intrathecal baclofen pump implantation procedures. Patients were then reviewed for the use of intraoperative crystalline vancomycin powder. Those with a history of prior surgical site infection, chronic systemic infections or osteomyelitis were excluded. Anhydrous, crystalline vancomycin was utilized in the wound bed after completion of implantation, distributed evenly in the case of multiple incisions. Patients received 500 mg or 1,000 mg of crystallized vancomycin, evenly distributed through the wound layers based on a 70 kg weight cutoff. Intraoperative institutional standards of infection prophylaxis were unchanged throughout the study period. Infection rate of baclofen pump placement prior to the use of vancomycin powder from 2001-2009 at the same institution was monitored. Wound infection rate was tracked for a 12 month postoperative period. Six patients out of 26 baclofen pump implantations (23%) in this cohort were identified to have seven infections despite vancomycin powder placement in the lumbar and catheter wounds. Prior infection rates have been investigated for intrathecal drug delivery systems from 2001 to 2009 at the same institution with an overall infection rate of 3% (8/274). The use of vancomycin powder in patients with implants in this series did not reduce infection rates compared to published historical controls, and was elevated compared to institutional controls. Further prospective study of this high risk patient population is warranted.

Percutaneous Peripheral Nerve Stimulation for the Treatment of Chronic Low Back Pain: Two Clinical Case Reports of Sustained Pain Relief

As the leading cause of disability among U.S. adults, chronic low back pain (LBP) is one of the most prevalent and challenging musculoskeletal conditions. Neuromodulation provides an opportunity to reduce or eliminate the use of opioids to treat chronic LBP, but the cost and invasiveness of existing methods have limited its broad adoption, especially earlier in the treatment continuum. The present case report details the results of a novel method of short‐term percutaneous peripheral nerve stimulation (PNS) in 2 subjects with chronic LBP. At the end of the 1‐month therapy, stimulation was discontinued and the leads were withdrawn. PNS produced clinically significant improvements in pain (62% average reduction in Brief Pain Inventory Question #5, average pain), and functional outcomes (73% reduction in disability, Oswestry Disability Index; 83% reduction in pain interference, Brief Pain Inventory). Both subjects reduced nonopioid analgesic use by 83%, on average, and the one subject taking opioids ceased using all opioids. The only adverse event was minor skin irritation caused by a topical dressing. The clinically significant improvements were sustained at least 4 months after start of therapy (79% average reduction in pain; both reported minimal disability; 100% reduction in opioids; 74% reduction nonopioids). The results reveal the utility of this novel, short‐term approach and its potential as a minimally invasive neuromodulation therapy for use earlier in the treatment continuum to produce sustained pain relief and reduce or eliminate the need for analgesic medications, including opioids, as well as more expensive and invasive surgical or therapeutic alternatives.

Does Every Patient Require an Intrathecal Baclofen Trial Before Pump Placement

You are asked see a 45-year-old man with spastic paraparesis in your outpatient spasticity clinic. He has an established diagnosis of primary progressive multiple sclerosis (MS) that began some 15 years ago. He is alert and cognitively intact, with his primary challenge in symptom control during the past 4-5 years being hypertonia and weakness, ultimately resulting in his admission to a local long-term care facility about 2 years ago. He requires minimal assistance for upper and maximal assistance for lower extremity activities of daily living. He requires total assistance for transfers but once out of bed is reasonably mobile at household distances with a manual wheelchair, albeit slow and quite taxing. During most nights, he awakes 3-4 times from uncomfortable leg spasms. The spasms also occur intermittently during the day. His medical history is significant for pulmonary embolism 4 years ago (currently on warfarin), well-controlled hypertension, placement of a super pubic bladder catheter 6 months ago, and 2 incidences of stage 2 sacral decubiti during the past 18 monthsdboth now wellhealed. As part of the work-up for MS, he received a lumbar puncture after which he experienced a significant spinal headache. His past treatments for spasticity have included oral baclofen, which was discontinued at a dose of 40 mg/day because of sedation, and injection of moderately high-dose botulinum toxin into the key leg muscle will little noticeable improvement. He currently is taking 24 mg/d of tizanadine and 6 mg/d of diazepam, which he tolerates well but still does not adequately control his symptoms. On inspection, he demonstrates a typical “wind-swept” appearance of his legs, with flexion at the bilateral hips and knees and equinovarus at both ankles. Although the patient demonstrates little ability to actively move his lower extremity muscles, surprisingly his legs can be somewhat straightened passively with effort. All lower extremity muscles consistently demonstrated Modified Ashworth scores of 3 on examination. You are unsure whether passive end range of motion limitation at the hips, knees, and ankles is caused by contracture or spasticity. Ultimately, you feel the patient would benefit from placement of an intrathecal baclofen (ITB) pump. It so happens that one of your practice partners, who also provides spasticity management, overhears you presenting the case to your office scheduler to set a date and time for the standard ITB trial, before pump placement. Your partner asks gently, “Why don’t you just move directly to pump placement in this case? What purpose is the trial serving?” How would you answer your partner’s inquiry? Supporting a trial as usual is Gerald S. Bilsky, MD, and supporting the option of foregoing the trial is Michael Saulino, MD, PhD.

Poster 359: Safety and Performance Evaluation of ReWalk Reciprocating Gait Orthosis

cadence, stride length, gait cycle duration, double support, single support, stance duration, step duration prosthesis, step duration normal, swing duration prosthesis, swing duration normal, symmetry stance, symmetry step duration, symmetry double support, symmetry swing), out of which significant differences were found in velocity, step duration, and cadence. The velocity with unweighted prosthesis is 74.4 m/min, with 0.30 kg is 61.38 m/min and with 0.5 kg is 57.66 m/min. PCI increased with increase in weight of prosthesis. When comparing prosthetic limb with normal limb, there was no significant difference in other kinematic gait parameters. Conclusions: The study is ongoing, and initial data show that a small increase in prosthetic weight does not alter kinematic parameters, but PCI and velocity showed significant difference. The recent trend to provide light weight prosthesis for transtibial amputee may not be the optimum weight to get the best possible performance. Hence, instead of light-weight prosthesis, an optimal weight one would be more suitable for Indian population given the cost constraint.