Maximal Analgesic Effect Attained by the Use of Objective Neurophysiological Measurements With Closed-Loop Spinal Cord Stimulation.

Objectives: Spinal cord stimulation (SCS) has been challenged by the lack of neurophysiologic data to guide therapy optimization. Current SCS programming by trial-and-error results in suboptimal and variable therapeutic effects. A novel system with a physiologic closed-loop feedback mechanism using evoked-compound action potentials enables the optimization of physiologic neural dose by consistently and accurately activating spinal cord fibers.

Pacific Spine and Pain Society (PSPS) Evidence Review of Surgical Treatments for Lumbar Degenerative Spinal Disease: A Narrative Review.

Introduction: Interventional treatment options for the lumbar degenerative spine have undergone a significant amount of innovation over the last decade. As new technologies emerge, along with the surgical specialty expansion, there is no manuscript that utilizes a review of surgical treatments with evidence rankings from multiple specialties, namely, the interventional pain and spine communities. Through the Pacific Spine and Pain Society (PSPS), the purpose of this manuscript is to provide a balanced evidence review of available surgical treatments.

Prospective Six-Month Analysis of Multiarea Burst Spinal Cord Stimulation: Correlating Intraoperative Neuromonitoring With Postoperative Programming and Clinical Outcomes.

Introduction: DeRidder burst spinal cord stimulation (SCS) has shown superior relief from overall pain to traditional tonic neurostimulation therapies and a reduction in back and leg pain. However, nearly 80% of patients have two or more noncontiguous pain areas. This affects the ability to effectively program stimulation and deliver long-term efficacy of the therapy.

Neurophysiological outcomes that sustained clinically significant improvements over 3 years of physiologic ECAP-controlled closed-loop spinal cord stimulation for the treatment of chronic pain.

Introduction: A novel, spinal cord stimulation (SCS) system with a physiologic closed-loop (CL) feedback mechanism controlled by evoked compound action potentials (ECAPs) enables the optimization of physiologic neural dose and the accuracy of the stimulation, not possible with any other commercially available SCS systems. The report of objective spinal cord measurements is essential to increase the transparency and reproducibility of SCS therapy. Here, we report a cohort of the EVOKE double-blind randomized controlled trial treated with CL-SCS for 36 months to evaluate the ECAP dose and accuracy that sustained the durability of clinical improvements.

Early Functional Outcomes in Low Back Pain Subjects with a Novel Interspinous Fusion Device: REFINE Study 6-Month Results.

Purpose: Lumbar interlaminar decompression with interspinous fixation is an established safe and effective treatment for spinal stenosis. Early maintenance of improvements in pain intensity and function are critical for durability of symptom relief. The purpose of this study was to investigate the efficacy of minimally invasive treatments for low back pain during the early period after treatment and their utility in setting the course for longer term success.

ECAP-controlled closed-loop versus open-loop SCS for the treatment of chronic pain: 36-month results of the EVOKE blinded randomized clinical trial.

Introduction: The evidence for spinal cord stimulation (SCS) has been criticized for the absence of blinded, parallel randomized controlled trials (RCTs) and limited evaluations of the long-term effects of SCS in RCTs. The aim of this study was to determine whether evoked compound action potential (ECAP)-controlled, closed-loop SCS (CL-SCS) is associated with better outcomes when compared with fixed-output, open-loop SCS (OL-SCS) 36 months following implant.

Methods: The EVOKE study was a multicenter, participant-blinded, investigator-blinded, and outcome assessor-blinded, randomized, controlled, parallel-arm clinical trial that compared ECAP-controlled CL-SCS with fixed-output OL-SCS.

Anticipating and preventing complications in spinal cord stimulator implantation.

Introduction: Spinal cord stimulation is considered a minor elective procedure. The inherent goal is to provide safe, reliable, effective treatment with mitigation of known potential risk of adverse events.

Areas Covered: This is a comprehensive literature review evaluating the most prevalent complications encountered with SCS implantation.

Regional Coverage Differences With Single- and Multi-Area Burst Spinal Cord Stimulation for Treatment of Chronic Pain.

Introduction: Burst spinal cord stimulation (SCS) has shown superior relief from overall pain and a reduction in back and leg pain compared with traditional tonic neurostimulation therapies. However, nearly 80% of patients have two or more noncontiguous pain areas. This can provide challenges in effectively programming stimulation and long-term therapy efficacy.

A Prospective, Observational, Open-Label, Non-Randomized, Multicenter Study Measuring Functional Outcomes in a Novel Interspinous Fusion Device in Subjects with Low Back Pain: REFINE Study.

Introduction: Lumbar degenerative disease and the accompanying pain and dysfunction affect a significant number of patients in the USA and around the world. As surgery and innovation are moving towards minimally invasive treatments, this study looks to explore interspinous fixation as a standalone posterior approach to treat lumbar degenerative disc disease in the presence of neurogenic claudication and spinal stenosis.

Methods: This study was approved by an institutional review board (IRB) and is actively enrolling in a single-arm, multicenter, prospective, open-label fashion.

Clinical Longevity of 106,462 Rechargeable and Primary Cell Spinal Cord Stimulators: Real World Study in the Medicare Population.

Introduction: Spinal cord stimulators (SCS) are available with either primary cell (PC) or rechargeable cell (RC) batteries. Although RC systems are proposed to have a battery longevity upward of nine years, in comparison with four years for PC systems, there are few studies of longevity of SCS in the real world.

Materials And Methods: This was an observational, nonrandomized, retrospective study of Medicare beneficiaries who received neurostimulator implants in the outpatient hospital.

Transfixation of the Sacroiliac Joint: Biomechanical Stability of a Dual-Implant Minimally Invasive Procedure.

Background: Despite minimally invasive techniques for sacroiliac joint fixation, clinical challenges remain. The investigators hypothesized the studied technique will transfix the sacroiliac joint to a level comparable to the intact sacroiliac joint.

Objectives: The study objective was to determine the dynamic stability of a square inter-joint implant using a triangular notch in opposing bone segments spanning the joint space.

A Prospective Multicenter Case Series Utilizing Intraoperative Neuromonitoring With Evoked Compound Action Potentials to Confirm Spinal Cord Stimulation Lead Placement.

Objectives: The use of intraoperative neuromonitoring (IONM) has been adapted to address issues of safety and proper lead positioning in spinal cord stimulation. This multicenter case series seeks to incorporate the use of evoked compound action potential (ECAP) and late response (LR) recording and compare it with the results obtained with IONM, specifically electromyography (EMG), for the confirmation of lead placement. This study aimed to establish a correlation between ECAPs, LR, and EMG and publish human recordings of ECAPs and LR during their use with IONM.

Durability of Clinical and Quality-of-Life Outcomes of Closed-Loop Spinal Cord Stimulation for Chronic Back and Leg Pain: A Secondary Analysis of the Evoke Randomized Clinical Trial.

Importance: Chronic pain is debilitating and profoundly affects health-related quality of life. Spinal cord stimulation (SCS) is a well-established therapy for chronic pain; however, SCS has been limited by the inability to directly measure the elicited neural response, precluding confirmation of neural activation and continuous therapy. A novel SCS system measures the evoked compound action potentials (ECAPs) to produce a real-time physiological closed-loop control system.

Improving the Management of Patients with Osteoporosis Undergoing Spinal Fusion: The Need for a Bone Mineral Density-Matched Interbody Cage.

With an increasingly aging population globally, a confluence has emerged between the rising prevalence of degenerative spinal disease and osteoporosis. Fusion of the anterior spinal column remains the mainstay surgical intervention for many spinal degenerative disorders. However, decreased vertebral bone mineral density (BMD), quantitatively measured by dual x-ray absorptiometry (DXA), complicates treatment with surgical interbody fusion as weak underlying bone stock increases the risk of post-operative implant-related adverse events, including cage subsidence.

Passive Recharge Burst Spinal Cord Stimulation Provides Sustainable Improvements in Pain and Psychosocial Function: 2-year Results From the TRIUMPH Study.

Study Design: Prospective, international, multicenter, single-arm, post-market study.

Objective: The aim of this study was to assess long-term safety and effectiveness of spinal cord stimulation using a passive recharge burst stimulation design for chronic intractable pain in the trunk and/or limbs. Herein we present 24-month outcomes from the TRIUMPH study (NCT03082261).

Burst spinal cord stimulation can attenuate pain and its affective components in chronic pain patients with high psychological distress: results from the prospective, international TRIUMPH study.

Background Context: Psychological characteristics such as catastrophizing and depression have been shown to negatively impact outcome prognosis after spinal interventions.

Purpose: To evaluate whether high psychological distress, defined as clinically elevated levels of catastrophizing and depression, is associated with poorer outcomes after spinal cord stimulation utilizing a passive recharge burst stimulation design. This proprietary waveform may uniquely attenuate the emotional aspects of chronic pain given its affects on the medial pain pathway projecting to the dorsal anterior cingulate cortex and anterior insula.

A Retrospective, Single-Center, Quantitative Analysis of Adverse Events in Patients Undergoing Spinal Stenosis with Neurogenic Claudication Using a Novel Percutaneous Direct Lumbar Decompression Strategy.

Introduction: Low-back pain with accompanying neurogenic claudication is a common diagnosis in pain and spine centers around the world, with an evolving algorithm of treatment. One option for the treatment of neurogenic claudication by decompressive strategies centers on percutaneous direct decompressive techniques. Although commonly employed in clinical practice, there have been no formal investigations looking at safety of percutaneous direct decompression without the use of an epidurogram and relying on osteal landmarks.

Multicenter Retrospective Review of Safety and Efficacy of a Novel Minimally Invasive Lumbar Interspinous Fusion Device.

Introduction: Several treatment options exist for those with spinal stenosis, as well as degenerative changes. This series evaluates the use of an interspinous fixation (ISF) device as performed by interventional pain physicians.

Methods: This is a retrospective analysis identifying 32 patients with the diagnosis of lumbar degenerative disc disease with secondary diagnosis of lumbar spinal stenosis being treated with ISF with Aurora Spine Zip Interspinous Spacer.

Peripherally Induced Reconditioning of the Central Nervous System: A Proposed Mechanistic Theory for Sustained Relief of Chronic Pain with Percutaneous Peripheral Nerve Stimulation.

Peripheral nerve stimulation (PNS) is an effective tool for the treatment of chronic pain, although its efficacy and utilization have previously been significantly limited by technology. In recent years, purpose-built percutaneous PNS devices have been developed to overcome the limitations of conventional permanently implanted neurostimulation devices. Recent clinical evidence suggests clinically significant and sustained reductions in pain can persist well beyond the PNS treatment period, outcomes that have not previously been observed with conventional permanently implanted neurostimulation devices.

Prospective Analysis Utilizing Intraoperative Neuromonitoring for the Evaluation of Inter-Burst Frequencies.

Background: Intraoperative neuromonitoring (IONM) for spinal cord stimulation (SCS) uses electromyography (EMG) responses to determine myotomal coverage as a marker for dermatomal coverage.

Objective: These responses can be utilized to evaluate the effects of stimulation platforms on the nervous system.

Methods: Eight patients were tested at inter-burst frequencies of 10 Hz, 20 Hz, 30 Hz, and 40 Hz using DeRidder Burst stimulation to determine the amplitude of onset of post-synaptic signal generation.