Intrathecal Baclofen Therapy in Patients With Multiple Sclerosis: Improved Outcomes and Reduced Costs Through Identification of Catheter Malfunction.

INTRODUCTION: Two patients previously implanted with intrathecal Baclofen (ITB) pumps for management of intractable spasticity due to multiple sclerosis (MS) were referred to our center for ongoing management of their spasticity. Initial evaluation of these patients revealed high levels of spasticity in the presence of ITB doses 10 times the average daily dose of our other MS patients. CLINICAL FACTS: High doses of ITB required frequent clinical visits and result in high drug and procedure costs. Both patients' daily doses were greater than 1000 mcg/day resulting in clinical visits every 1-2 months with drug and procedure costs ranging from 16 to 23 thousand dollars annually based on Medicare national average pricing for physician's office. Of the 59 MS patients receiving ITB therapy at our institution, the mean, median, and mode daily doses for ITB are 184, 115, and 159 mcg/day, respectively. The high ITB doses in these patients and poor spasticity control raised suspicion for pump/catheter malfunction and prompted immediate troubleshooting. FINDINGS: One patient's catheter was found to be disconnected from the pump and the other's catheter tip was outside the intrathecal space. In both cases, the patients were not receiving the therapy. After pump/catheter replacement, both patients received excellent clinical benefits from ITB at significantly lower daily doses. This reduction in dose resulted in decreased frequency of medication refills (twice annually) which resulted in decreased cost of care (12-19 thousand dollars savings annually per patient). DISCUSSION: These cases illustrate the need for early ITB pump troubleshooting to identify catheter problems, improve efficacy, and avoid unnecessary healthcare costs.

Intrathecal therapy for pain in cancer patients.

PURPOSE OF REVIEW: Intrathecal drug delivery systems (IDDS) for cancer pain remain little employed despite a high level of efficiency even though the technique is widely recommended. This review aims to summarize recent advances in IDDS for cancer patients. RECENT FINDINGS: The respective roles of catheter positioning, volume and flow rate in diffusion of intrathecal treatments, as well as the individual roles of blood pressure, heart rate, and amplitude of the respiratory movements in cerebrospinal fluid (CSF) treatment dispersion, are now well established. Models are available using MRI data. Morphine has long been the gold standard in first line treatment, but recent publications conclude that ziconotide has largely proven its efficiency and that adverse effects are controllable. Four recent publications have evaluated cohorts of cancer patients treated by IDDS in 315 patients. All found a great efficiency of intrathecal treatment for cancer pain. Technical innovations include new catheters and anchorage devices for easier placement and a lower rate of complication. Three-dimensional (3D) CT scan appears to be a noninvasive technique for the diagnosis of catheter complications. Ultrasound should be used to locate pump septum for refill. SUMMARY: All recent recommendations highlight the efficiency of IDDS and propose to use it sooner.

Advanced Innovations for Pain.

Chronic pain represents one of the most important public health problems in terms of both the number of patients afflicted and health care costs. Most patients with chronic pain are treated with medications as the mainstay of therapy, and yet most medically treated patients continue to report ongoing pain. Additionally, adverse effects from pain medications represent a major challenge for clinicians and patients. Spinal cord stimulation and intrathecal drug delivery systems are well-established techniques that have been utilized for over 25 years. Intrathecal drug delivery systems have proven efficacy for a wide variety of intractable pain conditions and fewer adverse effects than systemic medical therapy in patients with refractory cancer-related pain. Spinal cord stimulation is cost-effective and provides improved pain control compared with medical therapy in patients with a variety of refractory pain conditions including complex regional pain syndrome, painful diabetic neuropathy, and chronic radiculopathy. Patients who have intractable pain that has not responded to reasonable attempts at conservative pain care measures should be referred to a qualified interventional pain specialist to determine candidacy for the procedures discussed in this article.

Epidural steroids for spinal pain and radiculopathy: a narrative, evidence-based review.

PURPOSE OF REVIEW: Epidural steroid injections (ESIs) are the most commonly performed intervention in pain clinics across the USA and worldwide. In light of the growing use of ESIs, a recent spate of highly publicized infectious complications, and increasing emphasis on cost-effectiveness, the utility of ESI has recently come under intense scrutiny. This article provides an evidence-based review of ESIs, including the most up-to-date information on patient selection, comparison of techniques, efficacy, and complications. RECENT FINDINGS: The data strongly suggest that ESIs can provide short-term relief of radicular symptoms but are less convincing for long-term relief, and mixed regarding cost-effectiveness. Although some assert that transforaminal ESIs are more efficacious than interlaminar ESIs, and that fluoroscopy can improve treatment outcomes, the evidence to support these assertions is limited. SUMMARY: The cost-effectiveness of ESI is the subject of great debate, and similar to efficacy, the conclusions one draws appear to be influenced by specialty. Because of the wide disparities regarding indications and utilization, it is likely that indiscriminate use is cost-ineffective, but that judicious use in well-selected patients can decrease healthcare utilization. More research is needed to better refine selection criteria for ESI, and to determine which approach, what dose, and how many injections are optimal.

[Procedural pain assessment after spinal injections of corticosteroid]. / Douleur induite: complication méconnue des infiltrations péridurales aux corticoïdes chez l'adulte.

BACKGROUND: Spinal injections of corticosteroid are commonly performed by rheumatologists in their daily practice but little is known about the frequency, the intensity and the management of procedural pain observed in these osteoarticular injections in daily practice. AIM: To evaluate the prevalence and intensity of pain caused by spinal injections. METHODS: In this observational prospective study, data were collected over 6 months, for up to 44 procedures (corticosteroid spinal injection). Evaluation of the pain was evaluated immediately before and after the injection using Huskisson's visual analogue scale (VAS). Statistical analysis was carried out in order to compare patients who had suffered from pain whilst undergoing the procedure to those who had not. RESULTS: Data were analyzed for 17 patients (12 female, mean age 53.6 ± 10.5 years). Over 50% of patients experienced procedural pain. Significant predictive factors of genesis of the procedural pain were the young age (p=0.022) and the intensity of the initial pain (p < 0.001), while the existence of a co morbidity is rather a protective factor (p = 0.006). Others factors such us sex, origin, level of studies, socioeconomic conditions, didn't seem to have of effect on the procedural pain. CONCLUSION: Most patients undergoing spinal injections suffer from procedural pain. Specific research and guidelines for the management of procedural pain related to rheumatologic care should be established to improve the quality of care provided by physicians.

Respiratory failure following delayed intrathecal morphine pump refill: a valuable, but costly lesson.

BACKGROUND: Spinal analgesia, mediated by opioid receptors, requires only a fraction of the opioid dose that is needed systemically. By infusing a small amount of opioid into the cerebrospinal fluid in close proximity to the receptor sites in the spinal cord, profound analgesia may be achieved while sparing some of the side effects due to systemic opioids. Intraspinal drug delivery (IDD) has been increasingly used in patients with intractable chronic pain, when these patients have developed untoward side effects with systemic opioid usage. The introduction of intrathecal opioids has been considered one of the most important breakthroughs in pain management in the past three decades. A variety of side effects associated with the long-term usage of IDD have been recognized. Among them, respiratory depression is the most feared. OBJECTIVE: To describe a severe adverse event, i.e., respiratory failure, following delayed intrathecal morphine pump refill. CASE REPORT: A 65-year-old woman with intractable chronic low back pain, due to degenerative disc disease, and was referred to our clinic for an intraspinal drug delivery evaluation, after failing to respond to multidisciplinary pain treatment. Following a psychological evaluation confirming her candidacy, she underwent an outpatient patient-controlled continuous epidural morphine infusion trial. The infusion trial lasted 12 days and was beneficial in controlling her pain. The patient reported more than 90% pain reduction with improved distance for ambulation. She subsequently consented and was scheduled for permanent intrathecal morphine pump implantation. The intrathecal catheter was inserted at right paramedian L3-L4, with catheter tip advanced to L1, confirmed under fluoroscopy. Intrathecal catheter placement was confirmed by positive CSF flow and by myelogram. A non-programmable Codman 3000 constant-flow rate infusion pump was placed in the right mid quandrant between right rib cage and right iliac crest. The intrathecal infusion consisted of preservative free morphine, delivering 1.0 mg /day. Over the following 6 months, the dosage was gradually titrated up to 4 mg/day with satisfactory pain control without significant side effects. However, the patient was not able to return to the clinic for pump refill until 12 days later than the previously scheduled pump-refill date. Her pump was accessed and was noted to be empty. Her intrathecal pump was refilled with preservative free morphine, delivering 4 mg/day (the same daily dose as her previous refill). However, on the night of pump refill, 10 hours after the pump refill, the patient was found to be unresponsive by her family members. 911 was called. Upon arriving, paramedics found her in respiratory failure, with shallow breathing at a rate of 5/min, pulse oxymetry showing oxygen saturation about 55-58%. She was emergently intubated on site and rushed to local hospital ER. The on call physician for our clinic was immediately contacted, and advised the administration of intravenous Naloxone. Her respiratory effort improved dramatically after receiving a total of 0.6 mg IV Naloxone IV over 25 minutes. Her intrathecal pump was immediately accessed by clinic on call physician and the remainder of the medication in the catheter space was aspirated. The pump infusate was immediately diluted with preservative free normal saline, to deliver preservative free morphine at 1mg/day. She was transferred to the intensive care unit and extubated the next morning. She recovered fully without any sequelae. CONCLUSION: Loss of opioid tolerance due to delayed pump refill may subject patients to the development of severe respiratory depression. Meticulous approach should be employed when refilling pumps in these patients when their pumps are completely empty. To our knowledge, this is the first reported case of this type.

Practice choices and challenges in the current intrathecal therapy environment: an online survey.

OBJECTIVE: The objective of this study was to evaluate current practice characteristics, treatment choices, clinical experiences, and economic concerns associated with intrathecal therapy. DESIGN: Health care professionals in the United States, who were known to actively use intrathecal therapy in their practices, were recruited to participate in an online survey; contact information was obtained via Internet searches, university Websites, association memberships, industry databases, and personal contacts. Survey responses were summarized descriptively. RESULTS: Of the 329 practitioners who were contacted, 87 participated in the survey. Most participants specialized in anesthesiology (77.0%), worked in a private practice or private hospital (74.7%), and had been practicing pain management for more than 10 years (64.4%). Morphine was the most frequently used opioid for the initiation of intrathecal therapy (80.7% of practitioners), and 81.9% had used ziconotide in their practice. Most practitioners (63.9%) had treated at least one patient who developed a granuloma, and 66.0% of those practitioners had a patient experience permanent or temporary neurological injury due to a granuloma. Fewer than half of practitioners were satisfied with reimbursement from private insurance companies (25.3%) or workers compensation (34.9%), and 90.5% believed reimbursement rates for filling, refilling, and programming patient pumps are not adequate to cover practice costs. The majority of practitioners (56.6%) use fewer pumps in their practices because of reimbursement issues. CONCLUSIONS: Intrathecal pain management practices continue to evolve as the options for treatment increase, and the body of applicable scientific literature grows; however, economic considerations can influence clinical decisions and may interfere with treatment choice and patient access to therapy.

Safety assessment of intradiscal gene transfer: a pilot study.

BACKGROUND: Several recent in vitro and in vivo studies have reported the beneficial properties of gene delivery of therapeutic factors to the intervertebral disc, as a potential treatment strategy for degenerative disc disease; however, to date, no studies have assessed the safety and toxicity of the practical application of this treatment modality. PURPOSE: To assess the safety of inappropriately dosed or misdirected gene delivery to the spinal column in an in vivo model. STUDY DESIGN: The potential toxicity of gene therapy to the spinal column was assessed in this pilot study by monitoring clinical and histological changes in the spinal cord after intradural injections of an adenoviral vector containing the complementary deoxyribonucleic acid (cDNA) for potentially therapeutic factors in the treatment of degenerative disc disease. METHODS: Fourteen New Zealand White rabbits were divided into experimental groups to receive an intradural injection (<10 microL) of saline alone or saline in combination with recombinant transforming growth factor beta1 (TGF-beta1) or an adenoviral vector containing the cDNA for either TGF-beta1 (at previously established therapeutic or elevated concentrations) or bone morphogenic protein-2 (BMP-2). Animals were monitored clinically and spinal cords were harvested for histological analysis. RESULTS: No neurological deficits developed in any of the animals receiving injections of saline alone or saline in combination with the therapeutic dose of Ad-TGF-beta1, Ad-BMP-2, or with recombinant TGF-beta1. However, animals receiving a higher concentration of Ad-TGF-beta1 developed bilateral lower extremity paralysis with significant histological changes. CONCLUSIONS: Inappropriately dosed or directed gene delivery to the spinal column may result in significant complications. However, with appropriate dosing, a therapeutic window may exist where the potential benefits of gene therapy in the treatment of degenerative disc disease outweigh its risks.