Pope J.E.,Summit Pain Alliance |
Deer T.R.,Center for Pain Relief |
Amirdelfan K.,IPM Medical Group |
McRoberts W.P.,Holy Cross Hospital |
Azeem N.,Mayo Medical School
Current Neuropharmacology | Year: 2016
Background: Intrathecal drug delivery has undergone a revitalization following a better understanding of this delivery route and its pharmacokinetics. Driven by patient safety and outcomes, clinicians are motivated to rethink the traditional spinal infusion pump patient selection criteria and indications. We review the current understanding of the pharmacology of commonly employed intrathecal agents and the clinical relevance. Methods: Search strategies for data acquisition included Medline database, PubMed, Google scholar, along with international and national professional meeting content, with key words including pharmacology of opioids, intrathecal therapy, ziconotide, pharmacokinetics, and intrathecal drug delivery. The search results were limited to the English language. Results: Over 300 papers were identified. The literature was condensed and digested to evaluate the most commonly used medications in practice, sto serve as a foundation for review. We review on-label medications: ziconotide and morphine, and off label medications including fentanyl, sufentail, and hydromorphine. Conclusion: Intrathecal therapy has level-one evidence for use for malignant pain and nonmalignant pain, with continued cost savings and improved safety. To most effectively serve our patients, a clear appreciation for the pharmacology of these commonly employed medication is paramount. © 2016 Bentham Science Publishers.
Deer T.R.,Center for Pain Relief |
Grigsby E.,Napa Pain Institute |
Weiner R.L.,Dallas Neurosurgical and Spine Associates |
Wilcosky B.,801 Brewster |
Kramer J.M.,Spinal Modulation
Neuromodulation | Year: 2013
Objective The article aims to study the safety and effectiveness of dorsal root ganglion (DRG) stimulation with a new device in the treatment of chronic pain. Design This is a prospective, single-arm, pilot study. Setting Four clinical centers were used as setting for this study. Patients Ten (10) patients with chronic intractable pain of the trunk and/or limbs were included. Intervention A trial period of DRG stimulation was studied. Two to four leads, each with four electrical contacts, were inserted using a minimally invasive epidural approach and steered toward the lateral epidural space, near the DRG. Leads were attached to an external trial stimulator and stimulation therapy was provided for three to seven days. Outcome Measures Pain reduction using a visual analog scale, subject and physician-rated improvement, adverse event (AE) rates, device programming settings, and medication utilization was evaluated at baseline and at prospective follow-up time points during stimulation. Results On average, there was a 70% reduction in pain following stimulation (p = 0.0007). Eight of the nine patients experienced a clinically meaningful (>30%) reduction in pain, and seven of the nine reduced their pain medication utilization. Pain relief in specific anatomical regions such as the leg, back, and foot was also observed. No device-related AEs were reported. Conclusions These initial results suggest that stimulation of the DRG can reduce pain in those patients suffering from chronic pain. DRG stimulation may offer several potential benefits over other neuromodulation techniques, including the ability to target difficult-to-reach anatomies such as the low back and foot. © 2012 International Neuromodulation Society.
Hayek S.M.,University Hospitals and Outcomes Research Consortium |
Deer T.R.,Center for Pain Relief |
Pope J.E.,Napa Pain Institute |
Panchal S.J.,National Institute of Pain |
Patel V.,ACMI Pain Care
Pain Physician | Year: 2011
Background: Intrathecal drug infusion therapy is usually considered when spinal-acting analgesics or antispasmodics administered via the oral or transdermal routes fail to control patients' pain or are associated with unacceptable side effects. The intrathecal administration of centrally acting agents bypasses the blood-brain-barrier resulting in much higher cerebrospinal fluid (CSF) concentrations while using reduced amounts of medication to achieve equipotent doses. The intrathecal approach is associated with higher rates of satisfactory pain relief and lower rates of treatment failures and technical complications compared to the epidural route. A paucity of randomized controlled trials (RCTs) has led to concern regarding proper use, selection criteria, and safety of these devices. Cost effectiveness and comparative therapies have now also become a focus of discussion. Objective: The purpose of this systematic review is to evaluate and update the available evidence for the efficacy and safety of intrathecal infusions used in long-term management (> 6 months) of chronic pain. This paper will not focus on intrathecal administration for spasticity or movement disorders. Study Design: A systematic review of intrathecal infusion through implanted drug delivery devices for chronic pain. Methods: Literature search through EMBASE, Medline, Cochrane databases, and systematic reviews as well as peer-reviewed non-indexed journals from 1980 to December 2010. Studies are assessed using the Agency for Healthcare Research and Quality (AHRQ) criteria for observational studies and the Cochrane Musculoskeletal Review Group criteria for randomized trials. The level of evidence was determined using 5 levels of evidence, ranging from Level I to III with 3 subcategories in Level II, based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). Outcome Measures: The primary outcome measure for chronic non-cancer is pain relief (short-term relief ≤ one-year and long-term > one-year), whereas it is 3 months for cancer. Secondary outcome measures of improvement in functional status, psychological status, return to work, and reduction in opioid intake. Results: The level of evidence for this systematic review of non-cancer pain studies meeting the inclusion criteria of continuous use of an intrathecal drug delivery system (IDDS) for at least 12 months duration with at least 25 patients in the cohort, is Level II-3 based on USPSTF criteria. The level of evidence for this systemic review for cancer-related pain studies meeting the inclusion criteria of continuous use of IDDS for at least 3 months duration with at least 25 patients in the cohort is Level II-2 based on USPSTF criteria. Conclusion: Based on the available evidence, the recommendation for intrathecal infusion systems for cancer-related pain is moderate recommendation based on the high quality of evidence and the recommendation is limited to moderate based on the moderate quality of evidence from non-randomized studies for non-cancer related pain.
Interventional spine and pain procedures in patients on antiplatelet and anticoagulant medications: Guidelines From the American Society of Regional Anesthesia and Pain Medicine, the European Society of Regional Anaesthesia and Pain Therapy, the American Academy of Pain Medicine, the International Neuromodulation Society, the North American Neuromodulation Society, and the World Institute of Pain
Narouze S.,Western Reserve Hospital |
Benzon H.T.,Northwestern University |
Provenzano D.A.,Pain Diagnostics and Interventional Care |
Buvanendran A.,Rush University Medical Center |
And 4 more authors.
Regional Anesthesia and Pain Medicine | Year: 2015
Interventional spine and pain procedures cover a far broader spectrum than those for regional anesthesia, reflecting diverse targets and goals. When surveyed, interventional pain and spine physicians attending the American Society of Regional Anesthesia and Pain Medicine (ASRA) 11th Annual Pain Medicine Meeting exhorted that existing ASRA guidelines for regional anesthesia in patients on antiplatelet and anticoagulant medications were insufficient for their needs. Those surveyed agreed that procedure-specific and patient-specific factors necessitated separate guidelines for pain and spine procedures. In response, ASRA formed a guidelines committee. After preliminary review of published complication reports and studies, committee members stratified interventional spine and pain procedures according to potential bleeding risk as low-, intermediate-, and high-risk procedures. The ASRA guidelines were deemed largely appropriate for the low- and intermediate-risk categories, but it was agreed that the high-risk targets required an intensive look at issues specific to patient safety and optimal outcomes in pain medicine. The latest evidence was sought through extensive database search strategies and the recommendations were evidence-based when available and pharmacology-driven otherwise. We could not provide strength and grading of these recommendations as there are not enough well-designed large studies concerning interventional pain procedures to support such grading. Although the guidelines could not always be based on randomized studies or on large numbers of patients from pooled databases, it is hoped that they will provide sound recommendations and the evidentiary basis for such recommendations. © 2015 by American Society of Regional Anesthesia and Pain Medicine.
Vaisman J.,Pain and Wellness Center |
Markley H.,New England Regional Headache Center |
Ordia J.,Pain and Wellness Center |
Deer T.,Center for Pain Relief
Neuromodulation | Year: 2012
Introduction: This is a retrospective case series of five patients with intractable trigeminal autonomic cephalalgia (TAC) who were implanted with a supraorbital/supratrochlear neuromodulation system. Objectives: The aim of this Institutional Review Board-approved study was to investigate the percentage of pain relief, treatment response, pain level, work status, medication intake, implantation technique, lead placement, programming information, and device use. Results: Trial stimulation led to implantation of all five patients. All patients reported improvement in their functional status in regard to activities of daily living. The device was revised in two patients due to skin erosion. It was later reimplanted in both patients due to worsening of symptoms, again with good pain relief. The device was explanted in two other patients because of the need to perform a magnetic resonance imaging or implant an automatic implantable cardioverter defibrillator. The follow-up of the patients ranged between 18 months and 36 months, with a mean of 25.2 months. There was no change in work status. Following the implant, the Visual Analog Scale score was reduced to a mean of 1.6 from an initial mean score of 8.9. Three patients were completely weaned off opioid medications, while two patients continued to take opioid at a lower dosage. All patients experienced a decrease of the adjuvant neuropathic drugs. Conclusion: Supraorbital/supratrochlear nerve stimulation appears to be a promising modality for the treatment of patients with intractable TAC. © 2012 International Neuromodulation Society.
Deer T.R.,Center for Pain Relief |
Deer T.R.,West Virginia University |
Kapural L.,Cleveland Clinic
Pain Physician | Year: 2010
Background and Objectives: Lumbar canal stenosis is a common source of chronic low back and leg pain. Minimally Invasive Lumbar Decompression (mild® ) is a new minimally invasive treatment for pain relief from symptomatic central lumbar canal stenosis. The procedure involves limited percutaneous laminotomy and thinning of the ligamentum flavum in order to increase the critical diameter of the stenosed spinal canal. The objective of this technical report is to evaluate the acute safety of the mild procedure. Methods: Manual and electronic chart survey was conducted by 14 treating physicians located in 9 U.S. states on 90 consecutive patients who underwent the mild procedure. Patients within local geographical practice areas were selected in keeping with product Instructions For Use. Those patients requiring lumbar decompression via tissue resection at the perilaminar space, within the interlaminar space and at the ventral aspect of the lamina were treated. Data collected included any complications and/or adverse events occurring during or immediately following the procedure prior to discharge. Results: Of 90 procedures reviewed, there were no major adverse events or complications related to the devices or procedure. No incidents of dural puncture or tear, blood transfusion, nerve injury, epidural bleeding, or hematoma were observed. Limitations: Data were not specifically collected; however, regardless of difficulty, in this series none of the procedures were aborted and none resulted in adverse events. Efficacy parameters were not collected in this safety survey. Conclusions: This review demonstrates the acute safety of the mild procedure with no report of significant or unusual patient complications. To establish complication frequency and longer-term safety profile associated with the treatment, additional studies are currently being conducted. Survey data on file at Vertos Medical, Inc.
Abejon D.,Hospital Universitario Puerta Of Hierro Majadahonda |
Deer T.,Center for Pain Relief |
Verrills P.,Metro Spinal Clinic Research
Neuromodulation | Year: 2011
Introduction: Subcutaneous stimulation (peripheral nerve field stimulation) is a novel neuromodulation modality that has increased in its utilization during the last 10 years. It consists of introducing a lead in the subdermal level to stimulate the small nerve fibers in that layer. Unlike other neuromodulation techniques including direct peripheral nerve stimulation, spinal cord stimulation, or deep brain stimulation, the precise target is not identified. Materials and Methods: To date, there is no clear guideline on the appropriate depth or a method to achieve reproducibility of the appropriate depth to place these leads. From clinical experience, we have found that when electrodes are placed in a layer that is too superficial, stimulation is often painful or lacks efficacy. Further, if they are too deep, the patient may not feel adequate paresthesia or get uncomfortable stimulation including, in some circumstances, muscle contractions. Results: In this small series, we demonstrate a novel concept using a radiofrequency stimulation probe to identify the appropriate depth to place the lead. Reproducibility of results will add clarity to the accumulating data and hopefully increase the chances of adequate stimulation coverage and pain relief. © 2011 International Neuromodulation Society.
Deer T.R.,Center for Pain Relief |
Kim C.K.,Center for Pain Relief |
Bowman R.G.,Center for Pain Relief |
Ranson M.T.,Center for Pain Relief |
Yee B.S.,Center for Pain Relief
Pain Physician | Year: 2012
Background: Symptomatic lumbar spinal stenosis (LSS) patients often suffer from multiple etiologies, and patient symptoms must be differentiated and identified as either neurogenic claudication, radicular pain, or both. The most common symptom associated with LSS is neurogenic claudication, which has been reported to occur in 91% to 100% of the LSS patient population. Neurogenic claudication symptoms are described as pain radiating to the lower extremities that begins and worsens as the patient ambulates. Neurogenic claudication symptoms worsen over time and can eventually result in significant life-altering functional limitations. Symptomatic LSS patients may also suffer from radicular pain, which is a persistent pain transmitted through neural pathways, and is associated with inflammation of the exiting nerve root. Objective: To assess patient safety, pain reduction, and functional status of patients treated with percutaneous lumbar decompression. Study Design: Single-center, prospective clinical study of 46 consecutive patients with neurogenic claudication symptoms related to lumbar spinal stenosis. Setting: US interventional pain management practice. Methods: From March 2010 to January 2011, 46 LSS patients suffering from neurogenic claudication underwent mild percutaneous lumbar decompression. Of these, 12-week, 6-month and one-year followup was available for 35 patients. Outcome Assessment: Visual Analog Scale (VAS), Oswestry Disability Index (ODI), and Zurich Claudication Questionnaire (ZCQ). Outcomes were assessed at baseline, 12-week, 6-month and one-year follow-up. Results: One-year follow-up patients in this study experienced statistically and clinically significant improvement in physical function, as well as reduction of pain intensity. The initial improvement in these patients, which was significant, was sustained through one year, with no significant differences among the interim follow-up visit periods. These results demonstrate early improvement following treatment with a high degree of durability over time. There were no serious device or procedure-related complications reported in this study. Limitations: Single-center study with no control group. Conclusions: In this study, the mild procedure was shown to be safe. In addition, patients experienced significant improvement in mobility and reduction of pain one year after the procedure. One-year outcomes were not significantly different from interim results, indicating that the significant improvement following treatment, occurring as early as 12 weeks, was maintained through one year. This high degree of consistency over time indicates the durability of percutaneous lumbar decompression in the treatment of neurogenic claudication in symptomatic LSS.
Wallace M.S.,University of California at San Diego |
Rauck R.L.,Wake forest University |
Deer T.,Center for Pain Relief
Clinical Journal of Pain | Year: 2010
Background: Ziconotide is a nonopioid intrathecal analgesic used to manage moderate to severe chronic pain. Although ziconotide is approved in the United States for intrathecal monotherapy only, it is often used in combination with other intrathecal drugs in clinical practice. Objectives: The need exists for a critical assessment of the currently available published literature on ziconotide combination therapy. This review summarizes and evaluates the publications from preclinical and clinical peer-reviewed experiments that have investigated the safety and effectiveness of ziconotide in combination with a variety of other drugs. Methods/Results: Eleven relevant publications were identified through a systematic search of multiple databases. Discussion: In preclinical studies, additive or synergistic antinociceptive effects were discovered when ziconotide was used in combination with morphine, clonidine, or baclofen; however, no additional antinociceptive effects were observed when bupivacaine was added to ziconotide therapy. Safety data from animal studies revealed that ziconotide did not exacerbate morphine-induced respiratory depression, or clonidine-induced hypotension or bradycardia; however, ziconotide did potentiate morphine-induced hypotension and inhibition of gastrointestinal tract motility. Results from 2 open-label trials indicated that combination ziconotide and morphine therapy produced greater analgesia than was produced by the use of either drug alone. Preliminary support for the use of ziconotide in combination with morphine, baclofen, or hydromorphone was provided by case studies. Conclusions: Although clinical and preclinical studies provide some support for the use of ziconotide in combination with morphine, hydromorphone, clonidine, or baclofen, strong evidence-based data are limited. Controlled, long-term clinical trials are warranted. © 2010 by Lippincott Williams & Wilkins.
Pope J.E.,Center for Pain Relief |
Deer T.R.,Center for Pain Relief
Neuromodulation | Year: 2015
Introduction Intrathecal drug delivery is a well-defined strategy to treat malignant and nonmalignant pain. Ziconotide is a well-studied intrathecal medicine option that has many attractive qualities, as it is non-granulomagenic, overdose or underdose is not associated with cardiopulmonary compromise or death, and is a non-opoid analgesic. However, it has had slow adoption into pain care algorithms because it has been historically plagued with the connotation of having a narrow therapeutic window and a low sustainability rate. We introduce a novel dosing strategy to improve patient outcomes and sustainability. Methods Patients were identified as being an intrathecal candidate and trialed with ziconotide based on the current standard of care. Patient demographics, diagnosis, previous treatment failures, and pre-implant visual analog scale (VAS) scores were recorded. Once the trial was deemed successful, based on the dual bolusing strategy, the patient underwent device implantation. Consecutive patients were prospectively followed. Ziconotide was then initiated with a flex dosing strategy, weighted during nocturnal dosing. Outcome endpoints included: reduction in VAS, side effects, durability of therapy, and systemic opioid use prior to implant and at last visit were noted (calculated to daily morphine equivalents). Primary endpoint was tolerability of ziconotide at three months following new dosing strategy. No industry support or funding was obtained for this project. Results All enrolled patients met the endpoint of the study of tolerability of ziconotide at three months. Numbers declined to 75% of patients at four months, and 70% of patients at six months. The discontinuing side-effects were most commonly urinary retention and visual hallucinations. There were no serious adverse events and no unresolved complications reported. Numerical rating scale (NRS) decreased on average from 9.06 to 1.8. Opioid reduction in morphine equivalents averaged 91.5% Discussion The efficacy and tolerability of monotherapy ziconotide may be improved by using a weighted bolus flex dosing strategy as compared with slow continuous infusions. Conclusion We present a novel strategy to deliver ziconotide using a unique continuous infusion flex dosing strategy. Further randomized, prospective, higher-powered studies are needed to critically evaluate the conclusions suggested by this limited prospective case series. © 2015 International Neuromodulation Society.