The Polyanalgesic Consensus Conference (PACC)®: Intrathecal Drug Delivery Guidance on Safety and Therapy Optimization When Treating Chronic Noncancer Pain.

INTRODUCTION: The International Neuromodulation Society convened a multispecialty group of physicians and scientists based on expertise with international representation to establish evidence-based guidance on intrathecal drug delivery in treating chronic pain. This Polyanalgesic Consensus Conference (PACC)® project, created more than two decades ago, intends to provide evidence-based guidance for important safety and efficacy issues surrounding intrathecal drug delivery and its impact on the practice of neuromodulation. 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. Section leaders supervised literature searches of MEDLINE, BioMed Central, Current Contents Connect, Embase, International Pharmaceutical Abstracts, Web of Science, Google Scholar, and PubMed from 2017 (when PACC® last published guidelines) to the present. Identified studies were graded using the United States Preventive Services Task Force criteria for evidence and certainty of net benefit. Recommendations are based on the strength of evidence or consensus when evidence is scant. RESULTS: The PACC® examined the published literature and established evidence- and consensus-based recommendations to guide best practices. Additional guidance will occur as new evidence is developed in future iterations of this process. CONCLUSIONS: The PACC® recommends best practices regarding intrathecal drug delivery to improve safety and efficacy. The evidence- and consensus-based recommendations should be used as a guide to assist decision-making when clinically appropriate.

Outcomes of a Multicenter, Prospective, Crossover, Randomized Controlled Trial Evaluating Subperception Spinal Cord Stimulation at ≤1.2 kHz in Previously Implanted Subjects.

OBJECTIVE: The WHISPER randomized controlled trial (RCT) evaluates safety and clinical effectiveness of subperception spinal cord stimulation (SCS) at ≤1.2 kHz in subjects previously implanted with an SCS system for treatment of chronic, neuropathic pain. METHODS: WHISPER is a prospective, multicenter RCT with a crossover design sponsored by Boston Scientific, Marlborough, MA (ClinicalTrials.gov: NCT02314000). Eligible subjects were randomized (N = 140) to receive subperception or supraperception for three months and then crossed over to receive the alternative. Upon completion of crossover period, subjects who preferred subperception were followed up to one year. Overall pain, quality-of-life, and other outcomes were collected in the study. The primary endpoint was the overall pain responder rate (≥50% improvement from baseline) with no increase in medications. Secondary endpoints consisted of pain scores, physical disability, quality of life, and treatment preference. RESULTS: The study met its primary endpoint and demonstrated noninferiority between supraperception and subperception in a prespecified cohort of 70 randomized subjects (Interim Analysis). Thirty-nine percent of subjects with subperception settings and 29% with supraperception settings had a greater than or equal to 50% reduction in their overall pain scores with no increase in average daily medication at three-months post-activation as compared with baseline. Further assessment of all participating study subjects (N = 140) revealed similar results. Subjects were previously implanted 3.8 ± 2 years and had a disability score (Oswestry Disability Index) of 70.2 ± 11.4 at study start. Of the randomized subjects that completed the End of Period 2 Visit, 93 (66%) preferred subperception SCS and their mean overall pain reduced from 7.3 ± 1.1 (N = 89) at baseline to 4.0 ± 2.1 (N = 80) at 12-months post-activation. Post hoc analysis also demonstrated that multiple options provide superior outcomes, as supported by a 74% increase in the responder rate when subjects could choose their most effective option (47%) compared with supraperception alone (27%). DISCUSSION: Subperception SCS at ≤1.2 kHz is safe and effective in subjects with extreme physical disability and previously implanted for chronic pain. Further, by providing study participants with different waveform options, increased pain relief was achieved.

A practical guide to recognize, assess, treat and evaluate (RATE) primary care patients with chronic pain.

The management of patients with chronic pain is one of the most important issues In medicine and public health. Chronic pain conditions cause substantial suffering for patients, their significant others and society over years and even decades and increases healthcare utilization resources including the cost of medical care, loss of productivity and provision of disability services. Primary care providers are at the frontline in the identification and management of patients with chronic pain, as the majority of patients enter the healthcare system through primary care and are managed by primary care providers. Due to the complexity of chronic pain and the range of issues involved, the accurate diagnosis of the causes of pain and the formulation of effective treatment plans presents significant challenges in the primary care setting. In this review, we use the classification of pain types based on pathophysiology as the template to guide the assessment, treatment, and monitoring of patients with chronic pain conditions. We outline key methods that can be used to efficiently and accurately diagnose the putative pathophysiological mechanisms underlying chronic pain conditions and describe how this information should be used to tailor the treatment plan to meet the patient's needs. We discuss methods to evaluate patients and the impact of treatment plans over a series of consultations, with a particular focus on strategies to improve the patient's ability to self-manage their pain and related symptoms and perform daily functions despite persistent pain. Finally, we introduce the mnemonic RATE (Recognize, Assess, Treat, and Evaluate) as a general strategy that healthcare providers can use to aid their management of patients presenting with chronic pain.

Management Strategies for Spinal Cord Injury Pain Updated for the Twenty-First Century.

Traumatic spinal cord injury (SCI) often results in several life-altering impairments, including paralysis, sensory loss, and neurogenic bowel/bladder dysfunction. Some of these SCI-related conditions can be accommodated with compensatory strategies. Perhaps no SCI-associated condition is more troublesome and recalcitrant to the treating physiatrist than chronic neuropathic pain. In addition to the expected challenges in treating any chronic pain condition, treatment of SCI-related pain has the added difficulty of disruption of normal neural pathways that subserve pain transmission and attenuation. This article reviews selected treatment strategies for SCI-associated neuropathic pain.

Intracranial hypertension after spinal cord injury and suboptimal cervical fusion.

Idiopathic intracranial hypertension (IIH), also known as pseudotumor cerebri, is a syndrome of increased intracranial pressure. Secondary causes have been associated with IIH, but the pathogenesis is poorly understood, and most cases are idiopathic. We present a case of IIH after suboptimal surgical stabilization of a traumatic C5 spinal cord injury, American Spinal Injury Association Impairment Scale grade A. The patient underwent a posterior arthrodesis and fusion to stabilize the spine, and his symptoms gradually resolved. To our knowledge, we present the first reported case of intracranial hypertension after a traumatic spinal cord injury and failed surgical stabilization.

Practical considerations and patient selection for intrathecal drug delivery in the management of chronic pain.

Chronic pain continues to pose substantial and growing challenges for patients, caregivers, health care professionals, and health care systems. By the time a patient with severe refractory pain sees a pain specialist for evaluation and management, that patient has likely tried and failed several nonpharmacologic and pharmacologic approaches to pain treatment. Although relegated to one of the interventions of "last resort", intrathecal drug delivery can be useful for improving pain control, optimizing patient functionality, and minimizing the use of systemic pain medications in appropriately selected patients. Due to its clinical and logistical requirements, however, intrathecal drug delivery may fit poorly into the classic pain clinic/interventional model and may be perceived as a "critical mass" intervention that is feasible only for large practices that have specialized staff and appropriate office resources. Potentially, intrathecal drug delivery may be more readily adopted into larger practices that can commit the necessary staff and resources to support patients' needs through the trialing, initiation, monitoring, maintenance, and troubleshooting phases of this therapy. Currently, two agents - morphine and ziconotide - are approved by the United States Food and Drug Administration for long-term intrathecal delivery. The efficacy and safety profiles of morphine have been assessed in long-term, open-label, and retrospective studies of >400 patients with chronic cancer and noncancer pain types. The efficacy and safety profiles of ziconotide have been assessed in three double-blind, placebo-controlled trials of 457 patients, and safety has been assessed in 1,254 patients overall, with severe chronic cancer, noncancer, and acquired immunodeficiency syndrome pain types. Both agents are highlighted as first-line intrathecal therapy for the management of neuropathic or nociceptive pain. The purpose of this review is to discuss practical considerations for intrathecal drug delivery, delineate criteria for the identification and selection of candidates for intrathecal drug delivery, and consider which agent may be more appropriate for individual patients.

'In the Moment': An Analysis of Facilitator Impact During a Quality Improvement Process.

Facilitators frequently act 'in the moment' - deciding if, when and how to intervene into group process discussions. This paper offers a unique look at how facilitators impacted eleven primary care teams engaged in a 12-week quality improvement (QI) process. Participating in a federally funded QI trial, primary care practices in New Jersey and Pennsylvania formed practice-based teams comprised of physicians, nurses, administrative staff, and patients. External facilitators met with each team to help them identify and implement changes aimed at improving the organization, work relationships, office functions, and patient care. Audio-recordings of the meetings and descriptive field notes were collected. These qualitative data provided information on how facilitators acted 'in the moment' and how their interventions impacted group processes over time. Our findings reveal that facilitators impacted groups in multiple ways throughout the QI process, rather than through a linear progression of stages or events. We present five case examples that show what acting 'in the moment' looked like during the QI meetings and how these facilitator actions/interventions impacted the primary care teams. These accounts provide practical lessons learned and insights into effective facilitation that may encourage others in their own facilitation work and offer beneficial strategies to facilitators in other contexts.