Diaphragm Pacing: A Safety, Appropriateness, Financial Neutrality, and Efficacy Analysis of Treating Chronic Respiratory Insufficiency.

OBJECTIVES: This study aimed to evaluate the safety and applicability of treating chronic respiratory insufficiency with diaphragm pacing relative to mechanical ventilation. MATERIALS AND METHODS: A literature review and analysis were conducted using the safety, appropriateness, financial neutrality, and efficacy principles. RESULTS: Although mechanical ventilation is clearly indicated in acute respiratory failure, diaphragm pacing improves life expectancy, increases quality of life, and reduces complications in patients with chronic respiratory insufficiency. CONCLUSION: Diaphragm pacing should be given more consideration in appropriately selected patients with chronic respiratory insufficiency.

Effectiveness and Safety of Intrathecal Ziconotide: Final Results of the Patient Registry of Intrathecal Ziconotide Management (PRIZM).

BACKGROUND AND OBJECTIVES: The Patient Registry of Intrathecal Ziconotide Management evaluated the long-term effectiveness and safety of intrathecal ziconotide. METHODS: The study was a prospective, multicenter observational study of intrathecal ziconotide in US clinical practice. Patients were adults with severe chronic pain that warranted intrathecal therapy. Ziconotide was initiated as the single agent in the pump; however, other intrathecal medications were permitted. The primary efficacy outcome was ≥30% reduction in numeric pain rating scale score from baseline at week 12. A secondary outcome was patient global impression of change. Adverse events were solicited at each visit. RESULTS: The registry enrolled 93 patients. Seventy-four and 28 patients completed 12 weeks and 18 months of treatment, respectively. In the overall patient population, 17.4% had ≥30% pain reduction from baseline at week 12, with a mean reduction in pain of 10.9%. At month 18, 38.5% of patients had ≥30% pain reduction from baseline, with a mean pain reduction of 24.7%. Patient-rated improvement was reported in 67% of patients at week 12 and 71% at month 18. Almost all patients experienced adverse events, the most common of which were nausea (25.8%), confusional state (22.6%), and dizziness (20.4%). CONCLUSIONS: Final study analyses showed that intrathecal ziconotide provided clinically meaningful pain relief in 17.4% and 38.5% of patients at week 12 and month 18, respectively. At these same time points, patient-rated improvement was reported in at least two-thirds of patients. The safety profile was consistent with that listed in the ziconotide prescribing information.

Effectiveness and Safety of Intrathecal Ziconotide: Interim Analysis of the Patient Registry of Intrathecal Ziconotide Management (PRIZM).

BACKGROUND: The Patient Registry of Intrathecal Ziconotide Management (PRIZM) evaluated long-term effectiveness, safety, and tolerability of intrathecal ziconotide treatment in clinical practice. METHODS: Patient Registry of Intrathecal Ziconotide Management was an open-label, long-term, multicenter, observational study of adult patients with severe chronic pain. This interim analysis (data through July 10, 2015) of ziconotide as the first vs. not first intrathecal agent in pump included change from baseline in the Numeric Pain Rating Scale (NPRS; primary efficacy measure) and Patient Global Impression of Change (PGIC) scores. RESULTS: Enrollment closed at 93 patients; data collection was ongoing at the time of this interim analysis. Fifty-one patients (54.8%) received ziconotide as the first agent in pump (FIP+), whereas 42 (45.2%) did not (FIP-). Mean (SD) baseline NPRS scores were 7.4 (1.9) and 7.9 (1.6) in FIP+ and FIP- patients, respectively. Mean (SEM) percentage changes in NPRS scores were -29.4% (5.5%) in FIP+ patients (n = 26) and +6.4% (7.7%) in FIP- patients (n = 17) at month 6 and -34.4% (9.1%) in FIP+ patients (n = 14) and -3.4% (10.2%) in FIP- patients (n = 9) at month 12. Improvement from baseline, measured by PGIC score, was reported in 69.2% of FIP+ (n = 26) and 35.7% of FIP- (n = 14) patients at month 6 and 85.7% of FIP+ (n = 7) and 71.4% of FIP- (n = 7) patients at month 12. The most common adverse events (≥ 10% of patients overall as of the data cut) were nausea (19.6% vs. 7.1% of FIP+ vs. FIP- patients, respectively), confusional state (9.8% vs. 11.9%), and dizziness (13.7% vs. 7.1%). CONCLUSIONS: Greater improvements in efficacy outcomes were observed when ziconotide was initiated as first-line intrathecal therapy vs. not first intrathecal agent in pump. The adverse event profile was consistent with the ziconotide prescribing information.

Percutaneous Peripheral Nerve Stimulation for the Treatment of Chronic Low Back Pain: Two Clinical Case Reports of Sustained Pain Relief.

As the leading cause of disability among U.S. adults, chronic low back pain (LBP) is one of the most prevalent and challenging musculoskeletal conditions. Neuromodulation provides an opportunity to reduce or eliminate the use of opioids to treat chronic LBP, but the cost and invasiveness of existing methods have limited its broad adoption, especially earlier in the treatment continuum. The present case report details the results of a novel method of short-term percutaneous peripheral nerve stimulation (PNS) in 2 subjects with chronic LBP. At the end of the 1-month therapy, stimulation was discontinued and the leads were withdrawn. PNS produced clinically significant improvements in pain (62% average reduction in Brief Pain Inventory Question #5, average pain), and functional outcomes (73% reduction in disability, Oswestry Disability Index; 83% reduction in pain interference, Brief Pain Inventory). Both subjects reduced nonopioid analgesic use by 83%, on average, and the one subject taking opioids ceased using all opioids. The only adverse event was minor skin irritation caused by a topical dressing. The clinically significant improvements were sustained at least 4 months after start of therapy (79% average reduction in pain; both reported minimal disability; 100% reduction in opioids; 74% reduction nonopioids). The results reveal the utility of this novel, short-term approach and its potential as a minimally invasive neuromodulation therapy for use earlier in the treatment continuum to produce sustained pain relief and reduce or eliminate the need for analgesic medications, including opioids, as well as more expensive and invasive surgical or therapeutic alternatives.

The Application of Failure Modes and Effects Analysis Methodology to Intrathecal Drug Delivery for Pain Management.

OBJECTIVE: This study aimed to utilize failure modes and effects analysis (FMEA) to transform clinical insights into a risk mitigation plan for intrathecal (IT) drug delivery in pain management. METHODS: The FMEA methodology, which has been used for quality improvement, was adapted to assess risks (i.e., failure modes) associated with IT therapy. Ten experienced pain physicians scored 37 failure modes in the following categories: patient selection for therapy initiation (efficacy and safety concerns), patient safety during IT therapy, and product selection for IT therapy. Participants assigned severity, probability, and detection scores for each failure mode, from which a risk priority number (RPN) was calculated. Failure modes with the highest RPNs (i.e., most problematic) were discussed, and strategies were proposed to mitigate risks. RESULTS: Strategic discussions focused on 17 failure modes with the most severe outcomes, the highest probabilities of occurrence, and the most challenging detection. The topic of the highest-ranked failure mode (RPN = 144) was manufactured monotherapy versus compounded combination products. Addressing failure modes associated with appropriate patient and product selection was predicted to be clinically important for the success of IT therapy. CONCLUSIONS: The methodology of FMEA offers a systematic approach to prioritizing risks in a complex environment such as IT therapy. Unmet needs and information gaps are highlighted through the process. Risk mitigation and strategic planning to prevent and manage critical failure modes can contribute to therapeutic success.

Infection Rates of Electrical Leads Used for Percutaneous Neurostimulation of the Peripheral Nervous System.

BACKGROUND: Percutaneous neurostimulation of the peripheral nervous system involves the insertion of a wire "lead" through an introducing needle to target a nerve/plexus or a motor point within a muscle. Electrical current may then be passed from an external generator through the skin via the lead for various therapeutic goals, including providing analgesia. With extended use of percutaneous leads sometimes greater than a month, infection is a concern. It was hypothesized that the infection rate of leads with a coiled design is lower than for leads with a noncoiled cylindrical design. METHODS: The literature was retrospectively reviewed for clinical studies of percutaneous neurostimulation of the peripheral nervous system of greater than 2 days that included explicit information on adverse events. The primary endpoint was the number of infections per 1,000 indwelling days. RESULTS: Forty-three studies were identified that met inclusion criteria involving coiled (n = 21) and noncoiled (n = 25) leads (3 studies involved both). The risk of infection with noncoiled leads was estimated to be 25 times greater than with coiled leads (95% confidence interval [CI] 2 to 407, P = 0.006). The infection rates were estimated to be 0.03 (95% CI 0.01 to 0.13) infections per 1,000 indwelling days for coiled leads and 0.83 (95% CI 0.16 to 4.33) infections per 1,000 indwelling days for noncoiled leads (P = 0.006). CONCLUSIONS: Percutaneous leads used for neurostimulation of the peripheral nervous system have a much lower risk of infection with a coiled design compared with noncoiled leads: approximately 1 infection for every 30,000 vs. 1,200 indwelling days, respectively.

Interventions in chronic pain management. 1. Update on important definitions in pain management.

UNLABELLED: This self-directed learning module highlights definitions used in pain management. It is part of the chapter on chronic pain management in the Self-Directed Physiatric Education Program for practitioners in physical medicine and rehabilitation. Terms that describe pain and narcotic use that are frequently used and misused are reviewed. Complex regional pain syndrome criteria are presented. Mechanisms, criteria, and potential problems for practitioners to become certified in various areas of pain management are discussed. OVERALL ARTICLE OBJECTIVE: To define common terminology used in pain management, complex regional pain syndrome, and the criteria for pain management certification.

Interventions in chronic pain management. 2. Diagnosis of cervical and thoracic pain syndromes.

UNLABELLED: This self-directed learning module highlights approaches to the investigation of common cervical and thoracic conditions. It is part of the chapter on chronic pain management in the Self-Directed Physiatric Education Program for practitioners in physical medicine and rehabilitation. The differential diagnosis of cervical and thoracic syndromes as well as cervicogenic headache is reviewed. The need for a comprehensive history and physical examination is emphasized. Indications for diagnostic tests including magnetic resonance imaging, computed tomography scan, bone scan, diskography, radiographs, diagnostic injections, and electrodiagnostic studies are discussed with the idea that testing should be performed and interpreted with the specific clinical presentation in mind. OVERALL ARTICLE OBJECTIVE: To discuss the differential diagnoses for and investigation of common cervical and thoracic conditions and cervicogenic headache.

Interventions in chronic pain management. 3. Evaluation and management of lumbar pain syndromes.

UNLABELLED: This self-directed learning module highlights approaches to the investigation of selected lumbar spine conditions. It is part of the chapter on chronic pain management in the Self-Directed Physiatric Education Program for practitioners in physical medicine and rehabilitation. The first objective explores the diagnostic evaluation for groin and buttock pain in a 66-year-old man with pain during ambulation. The second objective describes the unique challenges of managing the adolescent with low back pain. OVERALL ARTICLE OBJECTIVE: To review evaluation and management strategies for selected lumbar pain syndromes.

Interventions in chronic pain management. 4. Monitoring progress and compliance in chronic pain management.

UNLABELLED: This self-directed learning module highlights the monitoring of progress and compliance in chronic pain management. It is part of the chapter on chronic pain in the Self-Directed Physiatric Education Program for practitioners in physical medicine and rehabilitation. Specifically, the first module focuses on the use of pain rating scales to monitor progress, and the second and third learning objectives focus on evaluating abuse potential and interpreting drug screens. The fourth objective discusses issues pertaining to closure of a workers' compensation complaint, including when to declare that a patient meets the requirements for the designation maximal medical improvement. OVERALL ARTICLE OBJECTIVE: To discuss monitoring of a patient's progress and compliance by describing how pain rating scales are used, what screening procedures are available to help identify patients at risk for drug abuse, and what the basis is for declaring a patient as having reached maximal medical improvement.

Interventions in chronic pain management. 5. Approaches to medication and lifestyle in chronic pain syndromes.

UNLABELLED: This self-directed learning module first reviews the importance of weight management and smoking cessation in the treatment of axial low back pain and then describes the use of medication in complex regional pain syndrome and trigeminal neuralgia. It is part of the chapter on chronic pain in the Self-Directed Physiatric Education Program for practitioners in physical medicine and rehabilitation. The first objective explores the correlation of tobacco usage and obesity with lower back pain. The second objective reviews the option for medication management in patients with complex regional pain syndromes. The third objective examines the management of trigeminal neuralgia in a patient with multiple sclerosis. OVERALL ARTICLE OBJECTIVE: To discuss the importance of addressing obesity and smoking cessation in patients with low back pain and medication usage in trigeminal neuralgia and complex regional pain syndromes.

Interventions in chronic pain management. 6. Interventional approaches to chronic pain management.

UNLABELLED: This self-directed learning module highlights strategies for interventional treatments for chronic pain disorders. It is part of the chapter on chronic pain in the Self-Directed Physiatric Education Program for practitioners in physical medicine and rehabilitation. Specifically, the first module reviews an interventional protocol for recalcitrant buttock and hip pain. The protocol includes hip and spinal injections, neuroablative lesioning, and percutaneous epidural neuroplasty. The second module reviews implantable treatments (spinal cord stimulation, implantable pumps) for intractable pain. OVERALL ARTICLE OBJECTIVE: To discuss interventional pain management approaches in the treatment of chronic pain disorders.

First-ever guidelines for spinal cord injuries.

How spinal cord injuries (SCI) are managed--especially in the critical early stages--has a profound effect on a patient's outcome. The publication of the first comprehensive SCI treatment guidelines is an important step in standardizing evidence-based care.

Intrathecal baclofen therapy: an update.

Intrathecal administration of baclofen is a well-established technique for modulating hypertonia secondary to upper motor neuron pathology. Despite the nearly 2 decades of widespread clinical use, this intervention presents many challenges to even experienced clinicians. The purpose of this clinical review is to describe some of the intricacies and subtleties of this treatment strategy. This narrative provides an overview of 3 topics: (1) an alternative methodology for intrathecal baclofen trials; (2) an algorithmic approach to troubleshooting intrathecal delivery systems; and (3) the utility of neurophysiologic assessments within various phases of intrathecal baclofen therapy.