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Charleston, WV, United States

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. Source


Deer T.R.,Center for Pain Relief | Grigsby E.,Napa Pain Institute | Weiner R.L.,Dallas Neurosurgical and Spine Associates | 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. Source


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. Source


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. Source


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. Source

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