Robert Levy - Academia.edu (original) (raw)

Papers by Robert Levy

Research paper thumbnail of Intracranial neurostimulation for pain control: a review

Pain physician

Intracranial neurostimulation for pain relief is most frequently delivered by stimulating the mot... more Intracranial neurostimulation for pain relief is most frequently delivered by stimulating the motor cortex, the sensory thalamus, or the periaqueductal and periventricular gray matter. The stimulation of these sites through MCS (motor cortex stimulation) and DBS (deep brain stimulation) has proven effective for treating a number of neuropathic and nociceptive pain states that are not responsive or amenable to other therapies or types of neurostimulation. Prospective randomized clinical trials to confirm the efficacy of these intracranial therapies have not been published. Intracranial neurostimulation is somewhat different than other forms of neurostimulation in that its current primary application is for the treatment of medically intractable movement disorders. However, the increasing use of intracranial neurostimulation for the treatment of chronic pain, especially for pain not responsive to other neuromodulation techniques, reflects the efficacy and relative safety of these intr...

Research paper thumbnail of Response to letter to the editor

Research paper thumbnail of Polyanalgesic Consensus Conference--2012: consensus on diagnosis, detection, and treatment of catheter-tip granulomas (inflammatory masses)

Neuromodulation : journal of the International Neuromodulation Society

Continuous intrathecal infusion of drugs to treat chronic pain and spasticity has become a standa... more Continuous intrathecal infusion of drugs to treat chronic pain and spasticity has become a standard part of the algorithm of care. The use of opioids has been associated with noninfectious inflammatory masses at the tip of the intrathecal catheter, which can result in neurologic complications. The Polyanalgesic Consensus Conference is a meeting of a group of well-published and experienced practitioners; the purpose of the meeting is to update the standard of care for intrathecal therapies to reflect current knowledge gleaned from literature and clinical experience. An exhaustive literature search was performed, and information from this search was provided to panel members. Analysis of the published literature was coupled with the clinical experience of panel participants to form recommendations regarding intrathecal inflammatory masses or granulomas. The panel has made recommendations for the prevention, diagnosis, and management of intrathecal granulomas. The use of chronic infusi...

Research paper thumbnail of Practice Choices and Challenges in the Current Intrathecal Therapy Environment: An Online Survey

Pain Medicine, 2009

Objective. The objetive of this study was to evaluate current practice characteristics, treatment... more Objective. The objetive of this study was to evaluate current practice characteristics, treatment choices, clinical experiences, and economic concerns associated with intrathecal therapy.

Research paper thumbnail of Systematic Safety Review and Meta-Analysis of Procedural Experience Using Percutaneous Access to Treat Symptomatic Lumbar Spinal Stenosis

Pain Medicine, 2012

This systematic safety review reports multicenter safety results of symptomatic lumbar spinal ste... more This systematic safety review reports multicenter safety results of symptomatic lumbar spinal stenosis (LSS) patients treated with percutaneous lumbar decompression. All percutaneous lumbar decompression institutional review board-approved study patients, as well as a retrospective safety survey, were included in this review. All study centers followed the same widely accepted and standardized procedure for percutaneous decompression and utilized the same criteria when observing and reporting device- or procedure-related adverse events. In addition to safety data, Oswestry Disability Index scores were used to document baseline functional disability, and visual analog scale values defined the intensity of baseline back and leg pain. Treatment outcomes of patients who reached 1-year follow-up were also included. Of the 373 patients included in this safety review, there were no reports of major device- or procedure-related adverse events, and there were no mortalities. Major complications were defined as any device- or procedure-related event that required intervention, including events such as incidental durotomy, epidural hematoma, infection, or bleeding that required transfusion. One-year efficacy data showed statistically significant improvement in pain and mobility, further supporting the excellent safety profile of percutaneous lumbar decompression. In this safety review, percutaneous lumbar decompression proved to be a safe procedure. Compared with other more invasive lumbar decompression techniques, percutaneous lumbar decompression has demonstrated significantly better safety. This high level of safety is particularly vital for the rapidly growing elderly LSS patient population with increased treatment risks related to comorbid medical issues.

Research paper thumbnail of Polyanalgesic Consensus Conference 2007: Recommendations for the Management of Pain by Intrathecal (Intraspinal) Drug Delivery: Report of an Interdisciplinary Expert Panel

Neuromodulation: Technology at the Neural Interface, 2007

Background. Expert panels of physicians and nonphysicians in the field of intrathecal therapies c... more Background. Expert panels of physicians and nonphysicians in the field of intrathecal therapies convened in 2000 and 2003 to make recommendations for the rational use of intrathecal analgesics based on the preclinical and clinical literature known up to those times. An expert panel of physicians convened in 2007 to update previous recommendations and to form guidelines for the rational use of intrathecal opioid and nonopioid agents. Methods. A review of preclinical and clinical published relevant studies from 2000 to 2006 was undertaken and disseminated to a convened expert panel of physicians and nonphysicians. Focused discussions were held on the rational use of intrathecal agents and a survey asking questions regarding intrathecal therapies management was given to the panelists. Results. The panelists, after review of the literature from 2000 to 2006 and discussion, created an updated algorithm for the rational use of intrathecal opioid and nonopioid agents in patients with nonmalignant and end-of-life pain. Of note is that the panelists felt that ziconotide, based on new and relevant literature and experience, should be updated to a line one intrathecal drug.

Research paper thumbnail of Implementing the SAFE Principles for the Development of Pain Medicine Therapeutic Algorithms That Include Neuromodulation Techniques

Neuromodulation: Technology at the Neural Interface, 2009

Currently accepted chronic pain treatment algorithms have positioned therapies according to level... more Currently accepted chronic pain treatment algorithms have positioned therapies according to levels of invasiveness and up-front costs. After reviewing updated literature on efficacy and cost outcomes of care for patients with chronic pain that include interventional implantable technologies, we offer a new model of thinking when formulating algorithms of care that might include more invasive and costly interventions such as spinal cord stimulation, the SAFE principles. These SAFE principles include "safety," "appropriateness," "fiscal neutrality," and "efficacy."

Research paper thumbnail of Future Trends in the Development of Local Drug Delivery Systems: Intraspinal, Intracerebral, and Intraparenchymal Therapies

Neuromudulation: Technology at the Neural Interface, 2002

Due to successful use of intrathecal drug delivery in the management of refractory pain and spast... more Due to successful use of intrathecal drug delivery in the management of refractory pain and spasticity, new agents and indications are now being investigated. Preclinical studies of neurotrophic factors, molecules necessary for neuroneal survival and development, suggest that these agents may be beneficial for patients with neurologic disorders. Because neurotrophic factors do not cross the blood-brain barrier following systemic administration, local delivery routes, including intrathecal, intracerebroventrical, and intraparenchymal routes, are being studied; research is being conducted on intrathecal delivery for amyotrophic lateral sclerosis (ALS), intracerebroventricular delivery for Parkinson's disease and Alzheimer's disease, and intrahippocampal delivery for seizure disorders. Treatment of other neurologic disorders, such as brain tumors and HIV-related viral infections, also may be optimized by methods of local drug delivery, including intratumoral and intraparenchymal administration of potentially effective agents. Intraspinal, intratumoral, and intraparenchymal routes of administration are speculated to become critical components of treatment for a variety of neurological indications.

Research paper thumbnail of Future Directions for Intrathecal Pain Management: A Review and Update From the Interdisciplinary Polyanalgesic Consensus Conference 2007

Neuromodulation: Technology at the Neural Interface, 2008

Background. Expert panels of physicians and nonphysicians, all expert in intrathecal (IT) therapi... more Background. Expert panels of physicians and nonphysicians, all expert in intrathecal (IT) therapies, convened in the years 2000 and 2003 to make recommendations for the rational use of IT analgesics, based on the preclinical and clinical literature known up to those times, presentations of the expert panels, discussions on current practice and standards, and the result of sur veys of physicians using IT agents. An expert panel of physicians and nonphysicians has convened in 2007 to update information known regarding IT therapies and to update information on new and novel opioid and nonopioid analgesic compounds that might show promise for IT use. Methods. A review of preclinical and clinical published relevant studies from 2000 to 2006 was undertaken and disseminated to a convened expert panel of physicians and nonphysicians to discuss new and novel analgesic agents for IT use. Results. The panelists identified several agents that were worthy of future studies for the clinical and rational use of IT agents that are presented in this article. Conclusions. A list of nonopioid IT analgesics, including gabapentin , adenosine , octreotide , the χ -conopeptide, Xen2174 , the conopeptide, neurotensis 1 agonist, CGX-1160 , the ω -conotoxin, AM-336 , and physostigmine , were identified as worthy of future research by the panelists.

Research paper thumbnail of Management of Intrathecal Catheter-Tip Inflammatory Masses: An Updated 2007 Consensus Statement From An Expert Panel

Neuromodulation: Technology at the Neural Interface, 2008

Background. Expert panel of physicians and nonphysicians, all expert in intrathecal (IT) therapie... more Background. Expert panel of physicians and nonphysicians, all expert in intrathecal (IT) therapies, convened in the years 2000 and 2003 to make recommendations for the rational use of IT analgesics based on the preclinical and clinical literature known up to those times, presentations of the expert panel, discussions on current practice and standards, and the result of sur veys of physicians using IT agents. An expert panel of physicians and convened in 2007 to review previous recommendations and to form recommendations for the rational use of IT agents as they pertain to new scientific and clinical information regarding the etiology, prevention and treatment for IT granuloma. Method. A review of preclinical and clinical literature from 2000 to 2006 was undertaken and disseminated to an expert panel of physicians. Focused discussions concerning the rational use of IT agents and its relationship to the etiology of, prevention of, and treatment of IT granuloma were held. Results. This report presents here new knowledge of the etiology of catheter tip granuloma and guidelines for its prevention and treatment.

Research paper thumbnail of NANS Training Requirements for Spinal Cord Stimulation Devices: Selection, Implantation, and Follow-up

Neuromodulation: Technology at the Neural Interface, 2009

Research paper thumbnail of Polyanalgesic Consensus Conference 2012: Recommendations for the Management of Pain by Intrathecal (Intraspinal) Drug Delivery: Report of an Interdisciplinary Expert Panel

Neuromodulation: Technology at the Neural Interface, 2012

Introduction: Targeted intrathecal drug infusion to treat moderate to severe chronic pain has bec... more Introduction: Targeted intrathecal drug infusion to treat moderate to severe chronic pain has become a standard part of treatment algorithms when more conservative options fail. This therapy is well established in the literature, has shown efficacy, and is an important tool for the treatment of both cancer and noncancer pain; however, it has become clear in recent years that intrathecal drug delivery is associated with risks for serious morbidity and mortality.

Research paper thumbnail of Best Practices for Intrathecal Drug Delivery for Pain

Neuromodulation: Technology at the Neural Interface, 2014

The objective of this study was to identify best practices and provide guidance to clinicians to ... more The objective of this study was to identify best practices and provide guidance to clinicians to ensure safety and optimize intrathecal drug delivery for chronic intractable pain. Twelve experienced pain medicine practitioners-eight anesthesiologists, one neurosurgeon, one physiatrist, one clinical psychologist, and one advanced practice registered nurse-from the United States, Australia, and Europe gathered to identify and publish consensus on best practices in three areas related to safe intrathecal therapy for pain: safety and monitoring, patient and device management, and patient selection and trialing. Intrathecal drug delivery is a valuable alternative drug delivery system for many patients with severe chronic or end-of-life pain. While device-related complications (mostly with catheters) and surgical-site infections can occur, the main therapy-related safety issues associated with intrathecal drug delivery arise primarily with inadequate patient monitoring (e.g., respiratory depression), inflammatory mass (e.g., high doses and concentrations of opioids), wound healing, dosing errors (e.g., medication concentration and pump programming), pump fills or refills (e.g., pocket fills), and interaction with concomitant systemic medications (e.g., opioids and benzodiazepines). Many of the reported adverse events and complications of intrathecal drug delivery can be prevented by adequate clinician training, implementation of best practices, and experience. In adopting the therapy, patients must be apprised of its risks and benefits. Physicians and patients must partner to achieve both safety and effectiveness.

Research paper thumbnail of Polyanalgesic consensus conference 2003: an update on the management of pain by intraspinal drug delivery— report of an expert panel

Journal of Pain and Symptom Management, 2004

Intraspinal drug infusion using fully implantable pump and catheter systems is a safe and effecti... more Intraspinal drug infusion using fully implantable pump and catheter systems is a safe and effective therapy for selected patients with chronic pain. The options for this approach are increasing, as drugs that are commercially available for systemic administration are adapted to this use and other drugs that are in development specifically for intraspinal administration become available. In 2000 a Polyanalgesic Consensus Conference was organized to evaluate the existing literature and develop guidelines for drug selection. The major outcome of this effort, an algorithm for drug selection, was based on the best available evidence at the time. Rapid changes have occurred in the science and practice of intraspinal infusion and a Polyanalgesic Consensus Conference 2003 was organized to pursue the following goals: 1) to review the literature on intraspinal drug infusion since 1999, 2) to revise the 2000 drug-selection algorithm, 3) to develop guidelines for optimizing drug dosage and concentration, 4) to create a process for documenting minimum evidence supporting the use of a drug for intraspinal infusion, and 5) to clarify issues pertaining to compounding of drugs. Based on the best available evidence and expert opinion, consensus recommendations were developed in all these areas. The panel's conclusions may provide a foundation for clinical practice and a rational basis for new research.

Research paper thumbnail of Refractory Chronic Pain Screening Tool (RCPST): A Feasibility Study to Assess Practicality and Validity of Identifying Potential Neurostimulation Candidates

Pain Medicine, 2014

An international panel of pain specialists (anesthesiology, neurology, neurosurgery, and psycholo... more An international panel of pain specialists (anesthesiology, neurology, neurosurgery, and psychology) and research methodologists developed a screening tool to identify patients who may be suitable for spinal cord stimulation (SCS)--the Refractory Chronic Pain Screening Tool (RCPST) prototype. We describe a feasibility study to explore practicality and validity of this prototype. Consecutive outpatients were screened in two centers (United Kingdom and United States). Sixty chronic pain adults without satisfactory pain relief despite treatment were assessed using RCPST (by pain specialist without expertise in neurostimulation) and then evaluated by two pain specialists experienced in SCS implantation and management to determine whether the patient should be referred for SCS. To maintain blinding, the participating physicians did not inform each other or the patient of assessment outcome. Sensitivity and specificity of the RCPST prototype were calculated using implanters' judgment as "gold standard." The average age of patients was 47.7 years; 53% were female. Fifty-seven patients completed the study (one withdrew consent, two lost to follow-up). The pain specialists agreed the prototype was easy to use and took <10 minutes to complete. Implanter agreement was moderate (Kappa: 0.63, 95% confidence interval: 0.35-0.91). The prototype had low sensitivity (40%, 19-61%) and moderate specificity (78%, 65-92%). Using the same questionnaire with a modified decision algorithm, new prototypes were generated with range of high sensitivity (80-100%) and specificity (89-97%) values. The RCPST aims to identify patients that should be referred for consideration for neurostimulation. The final implant decision requires appropriate neurological diagnostic workup, psychological assessment, and trial stimulation. RCPST was considered practical for routine clinical practice and contained appropriate questions. Sensitivity needs to be improved. A future study should select and validate the ideal RCPST prototype.

Research paper thumbnail of Intracranial neurostimulation for pain control: a review

Pain physician

Intracranial neurostimulation for pain relief is most frequently delivered by stimulating the mot... more Intracranial neurostimulation for pain relief is most frequently delivered by stimulating the motor cortex, the sensory thalamus, or the periaqueductal and periventricular gray matter. The stimulation of these sites through MCS (motor cortex stimulation) and DBS (deep brain stimulation) has proven effective for treating a number of neuropathic and nociceptive pain states that are not responsive or amenable to other therapies or types of neurostimulation. Prospective randomized clinical trials to confirm the efficacy of these intracranial therapies have not been published. Intracranial neurostimulation is somewhat different than other forms of neurostimulation in that its current primary application is for the treatment of medically intractable movement disorders. However, the increasing use of intracranial neurostimulation for the treatment of chronic pain, especially for pain not responsive to other neuromodulation techniques, reflects the efficacy and relative safety of these intr...

Research paper thumbnail of Response to letter to the editor

Research paper thumbnail of Polyanalgesic Consensus Conference--2012: consensus on diagnosis, detection, and treatment of catheter-tip granulomas (inflammatory masses)

Neuromodulation : journal of the International Neuromodulation Society

Continuous intrathecal infusion of drugs to treat chronic pain and spasticity has become a standa... more Continuous intrathecal infusion of drugs to treat chronic pain and spasticity has become a standard part of the algorithm of care. The use of opioids has been associated with noninfectious inflammatory masses at the tip of the intrathecal catheter, which can result in neurologic complications. The Polyanalgesic Consensus Conference is a meeting of a group of well-published and experienced practitioners; the purpose of the meeting is to update the standard of care for intrathecal therapies to reflect current knowledge gleaned from literature and clinical experience. An exhaustive literature search was performed, and information from this search was provided to panel members. Analysis of the published literature was coupled with the clinical experience of panel participants to form recommendations regarding intrathecal inflammatory masses or granulomas. The panel has made recommendations for the prevention, diagnosis, and management of intrathecal granulomas. The use of chronic infusi...

Research paper thumbnail of Practice Choices and Challenges in the Current Intrathecal Therapy Environment: An Online Survey

Pain Medicine, 2009

Objective. The objetive of this study was to evaluate current practice characteristics, treatment... more Objective. The objetive of this study was to evaluate current practice characteristics, treatment choices, clinical experiences, and economic concerns associated with intrathecal therapy.

Research paper thumbnail of Systematic Safety Review and Meta-Analysis of Procedural Experience Using Percutaneous Access to Treat Symptomatic Lumbar Spinal Stenosis

Pain Medicine, 2012

This systematic safety review reports multicenter safety results of symptomatic lumbar spinal ste... more This systematic safety review reports multicenter safety results of symptomatic lumbar spinal stenosis (LSS) patients treated with percutaneous lumbar decompression. All percutaneous lumbar decompression institutional review board-approved study patients, as well as a retrospective safety survey, were included in this review. All study centers followed the same widely accepted and standardized procedure for percutaneous decompression and utilized the same criteria when observing and reporting device- or procedure-related adverse events. In addition to safety data, Oswestry Disability Index scores were used to document baseline functional disability, and visual analog scale values defined the intensity of baseline back and leg pain. Treatment outcomes of patients who reached 1-year follow-up were also included. Of the 373 patients included in this safety review, there were no reports of major device- or procedure-related adverse events, and there were no mortalities. Major complications were defined as any device- or procedure-related event that required intervention, including events such as incidental durotomy, epidural hematoma, infection, or bleeding that required transfusion. One-year efficacy data showed statistically significant improvement in pain and mobility, further supporting the excellent safety profile of percutaneous lumbar decompression. In this safety review, percutaneous lumbar decompression proved to be a safe procedure. Compared with other more invasive lumbar decompression techniques, percutaneous lumbar decompression has demonstrated significantly better safety. This high level of safety is particularly vital for the rapidly growing elderly LSS patient population with increased treatment risks related to comorbid medical issues.

Research paper thumbnail of Polyanalgesic Consensus Conference 2007: Recommendations for the Management of Pain by Intrathecal (Intraspinal) Drug Delivery: Report of an Interdisciplinary Expert Panel

Neuromodulation: Technology at the Neural Interface, 2007

Background. Expert panels of physicians and nonphysicians in the field of intrathecal therapies c... more Background. Expert panels of physicians and nonphysicians in the field of intrathecal therapies convened in 2000 and 2003 to make recommendations for the rational use of intrathecal analgesics based on the preclinical and clinical literature known up to those times. An expert panel of physicians convened in 2007 to update previous recommendations and to form guidelines for the rational use of intrathecal opioid and nonopioid agents. Methods. A review of preclinical and clinical published relevant studies from 2000 to 2006 was undertaken and disseminated to a convened expert panel of physicians and nonphysicians. Focused discussions were held on the rational use of intrathecal agents and a survey asking questions regarding intrathecal therapies management was given to the panelists. Results. The panelists, after review of the literature from 2000 to 2006 and discussion, created an updated algorithm for the rational use of intrathecal opioid and nonopioid agents in patients with nonmalignant and end-of-life pain. Of note is that the panelists felt that ziconotide, based on new and relevant literature and experience, should be updated to a line one intrathecal drug.

Research paper thumbnail of Implementing the SAFE Principles for the Development of Pain Medicine Therapeutic Algorithms That Include Neuromodulation Techniques

Neuromodulation: Technology at the Neural Interface, 2009

Currently accepted chronic pain treatment algorithms have positioned therapies according to level... more Currently accepted chronic pain treatment algorithms have positioned therapies according to levels of invasiveness and up-front costs. After reviewing updated literature on efficacy and cost outcomes of care for patients with chronic pain that include interventional implantable technologies, we offer a new model of thinking when formulating algorithms of care that might include more invasive and costly interventions such as spinal cord stimulation, the SAFE principles. These SAFE principles include "safety," "appropriateness," "fiscal neutrality," and "efficacy."

Research paper thumbnail of Future Trends in the Development of Local Drug Delivery Systems: Intraspinal, Intracerebral, and Intraparenchymal Therapies

Neuromudulation: Technology at the Neural Interface, 2002

Due to successful use of intrathecal drug delivery in the management of refractory pain and spast... more Due to successful use of intrathecal drug delivery in the management of refractory pain and spasticity, new agents and indications are now being investigated. Preclinical studies of neurotrophic factors, molecules necessary for neuroneal survival and development, suggest that these agents may be beneficial for patients with neurologic disorders. Because neurotrophic factors do not cross the blood-brain barrier following systemic administration, local delivery routes, including intrathecal, intracerebroventrical, and intraparenchymal routes, are being studied; research is being conducted on intrathecal delivery for amyotrophic lateral sclerosis (ALS), intracerebroventricular delivery for Parkinson's disease and Alzheimer's disease, and intrahippocampal delivery for seizure disorders. Treatment of other neurologic disorders, such as brain tumors and HIV-related viral infections, also may be optimized by methods of local drug delivery, including intratumoral and intraparenchymal administration of potentially effective agents. Intraspinal, intratumoral, and intraparenchymal routes of administration are speculated to become critical components of treatment for a variety of neurological indications.

Research paper thumbnail of Future Directions for Intrathecal Pain Management: A Review and Update From the Interdisciplinary Polyanalgesic Consensus Conference 2007

Neuromodulation: Technology at the Neural Interface, 2008

Background. Expert panels of physicians and nonphysicians, all expert in intrathecal (IT) therapi... more Background. Expert panels of physicians and nonphysicians, all expert in intrathecal (IT) therapies, convened in the years 2000 and 2003 to make recommendations for the rational use of IT analgesics, based on the preclinical and clinical literature known up to those times, presentations of the expert panels, discussions on current practice and standards, and the result of sur veys of physicians using IT agents. An expert panel of physicians and nonphysicians has convened in 2007 to update information known regarding IT therapies and to update information on new and novel opioid and nonopioid analgesic compounds that might show promise for IT use. Methods. A review of preclinical and clinical published relevant studies from 2000 to 2006 was undertaken and disseminated to a convened expert panel of physicians and nonphysicians to discuss new and novel analgesic agents for IT use. Results. The panelists identified several agents that were worthy of future studies for the clinical and rational use of IT agents that are presented in this article. Conclusions. A list of nonopioid IT analgesics, including gabapentin , adenosine , octreotide , the χ -conopeptide, Xen2174 , the conopeptide, neurotensis 1 agonist, CGX-1160 , the ω -conotoxin, AM-336 , and physostigmine , were identified as worthy of future research by the panelists.

Research paper thumbnail of Management of Intrathecal Catheter-Tip Inflammatory Masses: An Updated 2007 Consensus Statement From An Expert Panel

Neuromodulation: Technology at the Neural Interface, 2008

Background. Expert panel of physicians and nonphysicians, all expert in intrathecal (IT) therapie... more Background. Expert panel of physicians and nonphysicians, all expert in intrathecal (IT) therapies, convened in the years 2000 and 2003 to make recommendations for the rational use of IT analgesics based on the preclinical and clinical literature known up to those times, presentations of the expert panel, discussions on current practice and standards, and the result of sur veys of physicians using IT agents. An expert panel of physicians and convened in 2007 to review previous recommendations and to form recommendations for the rational use of IT agents as they pertain to new scientific and clinical information regarding the etiology, prevention and treatment for IT granuloma. Method. A review of preclinical and clinical literature from 2000 to 2006 was undertaken and disseminated to an expert panel of physicians. Focused discussions concerning the rational use of IT agents and its relationship to the etiology of, prevention of, and treatment of IT granuloma were held. Results. This report presents here new knowledge of the etiology of catheter tip granuloma and guidelines for its prevention and treatment.

Research paper thumbnail of NANS Training Requirements for Spinal Cord Stimulation Devices: Selection, Implantation, and Follow-up

Neuromodulation: Technology at the Neural Interface, 2009

Research paper thumbnail of Polyanalgesic Consensus Conference 2012: Recommendations for the Management of Pain by Intrathecal (Intraspinal) Drug Delivery: Report of an Interdisciplinary Expert Panel

Neuromodulation: Technology at the Neural Interface, 2012

Introduction: Targeted intrathecal drug infusion to treat moderate to severe chronic pain has bec... more Introduction: Targeted intrathecal drug infusion to treat moderate to severe chronic pain has become a standard part of treatment algorithms when more conservative options fail. This therapy is well established in the literature, has shown efficacy, and is an important tool for the treatment of both cancer and noncancer pain; however, it has become clear in recent years that intrathecal drug delivery is associated with risks for serious morbidity and mortality.

Research paper thumbnail of Best Practices for Intrathecal Drug Delivery for Pain

Neuromodulation: Technology at the Neural Interface, 2014

The objective of this study was to identify best practices and provide guidance to clinicians to ... more The objective of this study was to identify best practices and provide guidance to clinicians to ensure safety and optimize intrathecal drug delivery for chronic intractable pain. Twelve experienced pain medicine practitioners-eight anesthesiologists, one neurosurgeon, one physiatrist, one clinical psychologist, and one advanced practice registered nurse-from the United States, Australia, and Europe gathered to identify and publish consensus on best practices in three areas related to safe intrathecal therapy for pain: safety and monitoring, patient and device management, and patient selection and trialing. Intrathecal drug delivery is a valuable alternative drug delivery system for many patients with severe chronic or end-of-life pain. While device-related complications (mostly with catheters) and surgical-site infections can occur, the main therapy-related safety issues associated with intrathecal drug delivery arise primarily with inadequate patient monitoring (e.g., respiratory depression), inflammatory mass (e.g., high doses and concentrations of opioids), wound healing, dosing errors (e.g., medication concentration and pump programming), pump fills or refills (e.g., pocket fills), and interaction with concomitant systemic medications (e.g., opioids and benzodiazepines). Many of the reported adverse events and complications of intrathecal drug delivery can be prevented by adequate clinician training, implementation of best practices, and experience. In adopting the therapy, patients must be apprised of its risks and benefits. Physicians and patients must partner to achieve both safety and effectiveness.

Research paper thumbnail of Polyanalgesic consensus conference 2003: an update on the management of pain by intraspinal drug delivery— report of an expert panel

Journal of Pain and Symptom Management, 2004

Intraspinal drug infusion using fully implantable pump and catheter systems is a safe and effecti... more Intraspinal drug infusion using fully implantable pump and catheter systems is a safe and effective therapy for selected patients with chronic pain. The options for this approach are increasing, as drugs that are commercially available for systemic administration are adapted to this use and other drugs that are in development specifically for intraspinal administration become available. In 2000 a Polyanalgesic Consensus Conference was organized to evaluate the existing literature and develop guidelines for drug selection. The major outcome of this effort, an algorithm for drug selection, was based on the best available evidence at the time. Rapid changes have occurred in the science and practice of intraspinal infusion and a Polyanalgesic Consensus Conference 2003 was organized to pursue the following goals: 1) to review the literature on intraspinal drug infusion since 1999, 2) to revise the 2000 drug-selection algorithm, 3) to develop guidelines for optimizing drug dosage and concentration, 4) to create a process for documenting minimum evidence supporting the use of a drug for intraspinal infusion, and 5) to clarify issues pertaining to compounding of drugs. Based on the best available evidence and expert opinion, consensus recommendations were developed in all these areas. The panel's conclusions may provide a foundation for clinical practice and a rational basis for new research.

Research paper thumbnail of Refractory Chronic Pain Screening Tool (RCPST): A Feasibility Study to Assess Practicality and Validity of Identifying Potential Neurostimulation Candidates

Pain Medicine, 2014

An international panel of pain specialists (anesthesiology, neurology, neurosurgery, and psycholo... more An international panel of pain specialists (anesthesiology, neurology, neurosurgery, and psychology) and research methodologists developed a screening tool to identify patients who may be suitable for spinal cord stimulation (SCS)--the Refractory Chronic Pain Screening Tool (RCPST) prototype. We describe a feasibility study to explore practicality and validity of this prototype. Consecutive outpatients were screened in two centers (United Kingdom and United States). Sixty chronic pain adults without satisfactory pain relief despite treatment were assessed using RCPST (by pain specialist without expertise in neurostimulation) and then evaluated by two pain specialists experienced in SCS implantation and management to determine whether the patient should be referred for SCS. To maintain blinding, the participating physicians did not inform each other or the patient of assessment outcome. Sensitivity and specificity of the RCPST prototype were calculated using implanters' judgment as "gold standard." The average age of patients was 47.7 years; 53% were female. Fifty-seven patients completed the study (one withdrew consent, two lost to follow-up). The pain specialists agreed the prototype was easy to use and took <10 minutes to complete. Implanter agreement was moderate (Kappa: 0.63, 95% confidence interval: 0.35-0.91). The prototype had low sensitivity (40%, 19-61%) and moderate specificity (78%, 65-92%). Using the same questionnaire with a modified decision algorithm, new prototypes were generated with range of high sensitivity (80-100%) and specificity (89-97%) values. The RCPST aims to identify patients that should be referred for consideration for neurostimulation. The final implant decision requires appropriate neurological diagnostic workup, psychological assessment, and trial stimulation. RCPST was considered practical for routine clinical practice and contained appropriate questions. Sensitivity needs to be improved. A future study should select and validate the ideal RCPST prototype.