The Polyanalgesic Consensus Conference (PACC)®: Updates on Clinical Pharmacology and Comorbidity Management in Intrathecal Drug Delivery for Cancer Pain.

Introduction: The International Neuromodulation Society convened a multispecialty group of physicians based on expertise with international representation to establish evidence-based guidance on using intrathecal drug delivery in chronic pain treatment. This Polyanalgesic Consensus Conference (PACC)® project's scope is to provide evidence-based guidance for clinical pharmacology and best practices for intrathecal drug delivery for cancer pain.

Materials And Methods: Authors were chosen on the basis of their clinical expertise, familiarity with the peer-reviewed literature, research productivity, and contributions to the neuromodulation literature.

The Neurostimulation Appropriateness Consensus Committee (NACC)®: Recommendations for Spinal Cord Stimulation Long-Term Outcome Optimization and Salvage Therapy.

Introduction: The International Neuromodulation Society (INS) has recognized a need to establish best practices for optimizing implantable devices and salvage when ideal outcomes are not realized. This group has established the Neurostimulation Appropriateness Consensus Committee (NACC)® to offer guidance on matters needed for both our members and the broader community of those affected by neuromodulation devices.

Materials And Methods: The executive committee of the INS nominated faculty for this NACC® publication on the basis of expertise, publications, and career work on the issue.

Evidence-based consensus guidelines on patient selection and trial stimulation for spinal cord stimulation therapy for chronic non-cancer pain.

Spinal cord stimulation (SCS) has demonstrated effectiveness for neuropathic pain. Unfortunately, some patients report inadequate long-term pain relief. Patient selection is emphasized for this therapy; however, the prognostic capabilities and deployment strategies of existing selection techniques, including an SCS trial, have been questioned.

A Clinical Evaluation of the Accuracy of an Intrathecal Drug Delivery Device.

Introduction: Implantable intrathecal drug delivery (ITDD) devices are used to treat severe pain and spasticity refractory to conventional medical management. Although off-label medications and drug admixtures are commonly used in clinical practice and recommended by international guidelines, manufacturers state that this practice can result in device failure. The impact of off-label drugs and drug combinations on pump accuracy has hitherto never been assessed.

Is Europe also facing an opioid crisis?-A survey of European Pain Federation chapters.

Background: There is considerable public interest in whether Europe is facing an opioid crisis comparable to the one in the United States and the contribution of opioid prescriptions for pain to a potential opioid crisis.

Methods: A task force of the European Pain Federation (EFIC) conducted a survey with its national chapter representatives on trends of opioid prescriptions and of drug-related emergency departments and substance use disorder treatment admissions and of deaths as proxies of opioid-related harms over the last 20 years.

Results: Data from 25 European countries were received.

Persistent Spinal Pain Syndrome: A Proposal for Failed Back Surgery Syndrome and ICD-11.

Objective: For many medical professionals dealing with patients with persistent pain following spine surgery, the term Failed back surgery syndrome (FBSS) as a diagnostic label is inadequate, misleading, and potentially troublesome. It misrepresents causation. Alternative terms have been suggested, but none has replaced FBSS.

European* clinical practice recommendations on opioids for chronic noncancer pain - Part 1: Role of opioids in the management of chronic noncancer pain.

Background: Opioid use for chronic non-cancer pain (CNCP) is complex. In the absence of pan-European guidance on this issue, a position paper was commissioned by the European Pain Federation (EFIC).

Methods: The clinical practice recommendations were developed by eight scientific societies and one patient self-help organization under the coordination of EFIC.

Research design considerations for randomized controlled trials of spinal cord stimulation for pain: Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials/Institute of Neuromodulation/International Neuromodulation Society recommendations.

Spinal cord stimulation (SCS) is an interventional nonpharmacologic treatment used for chronic pain and other indications. Methods for evaluating the safety and efficacy of SCS have evolved from uncontrolled and retrospective studies to prospective randomized controlled trials (RCTs). Although randomization overcomes certain types of bias, additional challenges to the validity of RCTs of SCS include blinding, choice of control groups, nonspecific effects of treatment variables (eg, paresthesia, device programming and recharging, psychological support, and rehabilitative techniques), and safety considerations.

Analgesic Efficacy of "Burst" and Tonic (500 Hz) Spinal Cord Stimulation Patterns: A Randomized Placebo-Controlled Crossover Study.

Objectives: The aim of this study was to compare the efficacy in reducing pain intensity in adult subjects suffering from chronic back and leg pain of burst (BST) and tonic sub-threshold stimulation at 500 Hz (T500) vs. sham stimulation delivered by a spinal cord stimulation (SCS) device capable of automated postural adjustment of current intensity.

Materials And Methods: A multicentre randomized double-blind, three-period, three-treatment, crossover study was undertaken at two centers in the United Kingdom.

Systematic review and meta-analysis of placebo/sham controlled randomised trials of spinal cord stimulation for neuropathic pain.

The aims of this review were to systematically identify the current evidence base of placebo (or "sham") randomised controlled trials (RCTs) of spinal cord stimulation (SCS) for neuropathic pain and to undertake a meta-analysis to investigate the effectiveness of SCS when compared with a placebo comparator arm. Electronic databases were searched from inception until January 2019 for RCTs of SCS using a placebo/sham control. Searches identified 8 eligible placebo-controlled randomised trials of SCS for neuropathic pain.

A Randomized Controlled Trial of Subcutaneous Nerve Stimulation for Back Pain Due to Failed Back Surgery Syndrome: The SubQStim Study.

Objectives: To compare the effectiveness of peripheral nerve stimulation utilizing a subcutaneous lead implant technique-subcutaneous nerve stimulation (SQS) plus optimized medical management (SQS + OMM arm) vs. optimized medical management alone (OMM arm) in patients with back pain due to failed back surgery syndrome.

Patients And Methods: Patients were recruited from 21 centers, in Europe, Israel, and Australia.

The Neurostimulation Appropriateness Consensus Committee (NACC) Safety Guidelines for the Reduction of Severe Neurological Injury.

Introduction: Neurostimulation involves the implantation of devices to stimulate the brain, spinal cord, or peripheral or cranial nerves for the purpose of modulating the neural activity of the targeted structures to achieve specific therapeutic effects. Surgical placement of neurostimulation devices is associated with risks of neurologic injury, as well as possible sequelae from the local or systemic effects of the intervention. The goal of the Neurostimulation Appropriateness Consensus Committee (NACC) is to improve the safety of neurostimulation.

The Polyanalgesic Consensus Conference (PACC): Recommendations on Intrathecal Drug Infusion Systems Best Practices and Guidelines.

Introduction: Pain treatment is best performed when a patient-centric, safety-based philosophy is used to determine an algorithmic process to guide care. Since 2007, the International Neuromodulation Society has organized a group of experts to evaluate evidence and create a Polyanalgesic Consensus Conference (PACC) to guide practice.

Methods: The current PACC update was designed to address the deficiencies and innovations emerging since the previous PACC publication of 2012.

Quantifying dimensions of physical behavior in chronic pain conditions.

Background: Chronic pain, defined as persistent or recurrent pain lasting longer than 3 months, is a frequent condition affecting an important percent of population worldwide. Pain chronicity can be caused by many different factors and is a frequent component of many neurological disorders. An important aspect for clinical assessment and design of effective treatment and/or rehabilitation strategies is to better understand the impact of pain on domains of functioning in everyday life.

Comparison of the Effects of Intermittent Boluses to Simple Continuous Infusion on Patients' Global Perceived Effect in Intrathecal Therapy for Pain: A Randomized Double-Blind Crossover Study.

Objective: Intrathecal drug delivery (ITDD) is commonly used for intractable pain management. A paucity of good-quality studies in chronic noncancer patients and concerns over increased dosages have focused interest on different modes of administration. The aim of this international multicenter randomized double-blind crossover trial was to compare the efficacy of the same daily dose of drugs administered by intermittent boluses vs simple continuous infusion.

Parameters of Spinal Cord Stimulation and Their Role in Electrical Charge Delivery: A Review.

Objective: All spinal cord stimulation (SCS) parameters (amplitude, pulse width, frequency) influence the interaction of stimulation with the nervous system and impact the delivery of charge. Regardless of the stimulation pattern, there are certain crucial elements related to dose, and a basic fundamental knowledge of the parameters used to administer the therapy is fundamentally important.

Methods: This paper reviews basic concepts of energy delivery in neurostimulation (amplitude, pulse width, and frequency) and introduces the concept of the duty cycle and charge per sec as another way to characterize stimulation patterns.

Complications of Spinal Cord Stimulation and Peripheral Nerve Stimulation Techniques: A Review of the Literature.

Objective: Spinal cord and peripheral neurostimulation techniques have been practiced since 1967 for the relief of pain, and some techniques are also used for improvement in organ function. Neuromodulation has recognized complications, although very rarely do these cause long-term morbidity. The aim of this article is to present a review of complications observed in patients treated with neurostimulation techniques.

The appropriate use of neurostimulation: avoidance and treatment of complications of neurostimulation therapies for the treatment of chronic pain. Neuromodulation Appropriateness Consensus Committee.

Introduction: The International Neuromodulation Society (INS) has determined that there is a need for guidance regarding safety and risk reduction for implantable neurostimulation devices. The INS convened an international committee of experts in the field to explore the evidence and clinical experience regarding safety, risks, and steps to risk reduction to improve outcomes.

Methods: The Neuromodulation Appropriateness Consensus Committee (NACC) reviewed the world literature in English by searching MEDLINE, PubMed, and Google Scholar to evaluate the evidence for ways to reduce risks of neurostimulation therapies.

The appropriate use of neurostimulation of the spinal cord and peripheral nervous system for the treatment of chronic pain and ischemic diseases: the Neuromodulation Appropriateness Consensus Committee.

Introduction: The Neuromodulation Appropriateness Consensus Committee (NACC) of the International Neuromodulation Society (INS) evaluated evidence regarding the safety and efficacy of neurostimulation to treat chronic pain, chronic critical limb ischemia, and refractory angina and recommended appropriate clinical applications.

Methods: The NACC used literature reviews, expert opinion, clinical experience, and individual research. Authors consulted the Practice Parameters for the Use of Spinal Cord Stimulation in the Treatment of Neuropathic Pain (2006), systematic reviews (1984 to 2013), and prospective and randomized controlled trials (2005 to 2013) identified through PubMed, EMBASE, and Google Scholar.

Assessment of physical activity of patients with chronic pain.

Objectives: To define the key terms and concepts relating physical activity to chronic pain; to provide a brief overview of the various methods of assessment of physical activity; to review the current literature about physical activity and chronic pain; and to identify needs for future research.

Materials And Methods: A narrative review based on results of a PubMed search (to May 2011) and the references of recent systematic reviews.

Results: Many methods exist for measuring physical activity.

Refractory Chronic Pain Screening Tool (RCPST): a feasibility study to assess practicality and validity of identifying potential neurostimulation candidates.

Objective: 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.

Design: Consecutive outpatients were screened in two centers (United Kingdom and United States).

Best practices for intrathecal drug delivery for pain.

Objective: 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.

Methods: 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.

Conclusions: Intrathecal drug delivery is a valuable alternative drug delivery system for many patients with severe chronic or end-of-life pain.