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.

Defining the Boundaries of Patient Perception in Spinal Cord Stimulation Programming.

Objectives: Recent developments in spinal cord stimulation (SCS) programming have initiated new modalities of imperceptible stimulation. However, the boundaries of sensory perception are not well defined. The BEnchtop NEuromodulation Following endIng of Trial study aimed to create a map of perceptual threshold responses across a broad range of SCS parameters and programming to inform subperception therapy design.

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.

Multiphase Spinal Cord Stimulation in Participants With Chronic Back or Leg Pain: Results of the BENEFIT-02 Randomized Clinical Trial.

Objective: This study aimed to assess the safety and effectiveness of a new charge-distributed multiphase stimulation paradigm during an extended spinal cord stimulation (SCS) trial.

Materials And Methods: This prospective, multicenter, randomized, single-blind, feasibility study included participants with chronic low back and/or leg pain and baseline numerical rating scale (NRS) for overall pain intensity ≥6. After a successful commercial SCS trial, participants were randomized to multiphase SCS therapy A (approximately 600-1500 Hz) or B (approximately 300-600 Hz), delivered via an investigational external pulse generator and existing leads during an 11-to-12-day testing period.

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.

A Real-World Analysis of High-Frequency 10 kHz Spinal Cord Stimulation for the Treatment of Painful Diabetic Peripheral Neuropathy.

Background: Diabetes is one of the most prevalent chronic health conditions and diabetic neuropathy one of its most prevalent and debilitating complications. While there are treatments available for painful diabetic peripheral neuropathy (pDPN), their effectiveness is limited.

Method: This retrospective, multi-center, real-world review assessed pain relief and functional improvements for consecutive patients with diabetic neuropathy aged ≥18 years of age who were permanently implanted with a high-frequency (10 kHz) spinal cord stimulation (SCS) device.

Allogeneic mesenchymal precursor cells treatment for chronic low back pain associated with degenerative disc disease: a prospective randomized, placebo-controlled 36-month study of safety and efficacy.

Background Context Purpose: Evaluate the safety and efficacy of a single intradiscal injection of STRO-3+ adult allogeneic mesenchymal precursor cells (MPCs) combined with hyaluronic acid (HA) in subjects with chronic low back pain (CLBP) associated with degenerative disc disease (DDD) through 36-month follow-up.

Study Design/setting: A multicenter, randomized, controlled study conducted at 13 clinical sites (12 in the United States and 1 in Australia).

Subject Sample: A total of 100 subjects with chronic low back pain associated with moderate DDD (modified Pfirrmann score of 3-6) at one level from L1 to S1 for at least 6 months and failing 3 months of conservative treatment, including physical therapy were randomized in a 3:3:2:2 ratio to receive 6 million MPCs with HA, 18 million MPCs with HA, HA vehicle control, or saline control (placebo) treatment.

10-kHz Spinal Cord Stimulation for Chronic Postsurgical Pain: Results From a 12-Month Prospective, Multicenter Study.

Background: Chronic postsurgical pain (CPSP) can be caused by peripheral nerve injury (PNI) resulting from surgical procedures and has a significant neuropathic component. This prospective, single-arm study was conducted to document the effectiveness of 10-kHz spinal cord stimulation (10-kHz SCS) as a treatment for patients with CPSP.

Methods: Subjects with CPSP who were refractory to conventional medical interventions and reported pain scores of ≥5 cm on a 10-cm VAS underwent trial stimulations lasting up to 14 days.

The MIST Guidelines: The Lumbar Spinal Stenosis Consensus Group Guidelines for Minimally Invasive Spine Treatment.

Background: Lumbar spinal stenosis (LSS) can lead to compression of neural elements and manifest as low back and leg pain. LSS has traditionally been treated with a variety of conservative (pain medications, physical therapy, epidural spinal injections) and invasive (surgical decompression) options. Recently, several minimally invasive procedures have expanded the treatment options.

DRG FOCUS: A Multicenter Study Evaluating Dorsal Root Ganglion Stimulation and Predictors for Trial Success.

Introduction: Dorsal root ganglion stimulation (DRGS) is a powerful tool in the treatment of chronic, neuropathic pain. The premise of DRGS is similar to that of conventional spinal cord stimulation (cSCS), however, there is more variability in how it can be utilized. While it is this variability that likely gives it its versatility, DRGS is not as straightforward to implement as cSCS.

The Neurostimulation Appropriateness Consensus Committee (NACC) Recommendations for Infection Prevention and Management.

Introduction: The use of neurostimulation for pain has been an established therapy for many decades and is a major tool in the arsenal to treat neuropathic pain syndromes. Level I evidence has recently been presented to substantiate the therapy, but this is balanced against the risk of complications of an interventional technique.

Methods: The Neurostimulation Appropriateness Consensus Committee (NACC) of the International Neuromodulation Society convened an international panel of well published and diverse physicians to examine the best practices for infection mitigation and management in patients undergoing neurostimulation.

Results From the Partnership for Advancement in Neuromodulation Registry: A 24-Month Follow-Up.

Objective: This longitudinal, clinical outcome study was a multicenter, prospective, observational, registry with a 24-month assessment of patients implanted with spinal cord stimulation (SCS) systems for the management of chronic pain of the trunk and/or limbs.

Methods: On informed consent and institutional review board approval, 614 patients from 39 sites were enrolled within 30 days following permanent SCS system implantation. Medication usage, patient-reported pain relief (PRP), categorical ratings of pain relief, pain disability index scores (PDI), quality of life (QoL), and patient satisfaction were assessed at enrollment, 3-, 6-, 12-, 18-, and 24-month postimplant.

Prospective, Multicenter, Randomized, Double-Blinded, Partial Crossover Study to Assess the Safety and Efficacy of the Novel Neuromodulation System in the Treatment of Patients With Chronic Pain of Peripheral Nerve Origin.

Introduction: Currently available central nervous system treatment strategies are often insufficient in management of peripheral neuropathic pain, prompting a resurgence of neuromodulation focused on peripheral pain. A new peripheral nerve stimulation device was investigated in a prospective, randomized, double blind, crossover study, looking specifically at efficacy and safety, with Food and Drug Administration oversight.

Methods: Prospective, multicenter, randomized, double-blind, partial crossover study to assess safety and efficacy.

The appropriate use of neurostimulation: new and evolving neurostimulation therapies and applicable treatment for chronic pain and selected disease states. Neuromodulation Appropriateness Consensus Committee.

Introduction: The International Neuromodulation Society (INS) has determined that there is a need to provide an expert consensus that defines the appropriate use of neuromodulation technologies for appropriate patients. The Neuromodulation Appropriateness Consensus Committee (NACC) was formed to give guidance to current practice and insight into future developments.

Methods: The INS executive board selected members of the international scientific community to analyze scientific evidence for current and future innovations and to use clinical experience to fill in any gaps in information.

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.

An innovative case report detailing the successful treatment of post-thoracotomy syndrome with peripheral nerve field stimulation.

Introduction: The detrimental effects of post-thoracotomy pain syndrome is experienced worldwide; however, an effective treatment regimen remains elusive.

Methods: We report a case of post-thoracotomy pain syndrome effectively treated with peripheral nerve field stimulation (PNfS).

Results: In the presented case, the patient underwent permanent placement of the PSfS device after a successful trial period.

Case report: successful epiradicular peripheral nerve stimulation of the C2 dorsal root ganglion for postherpetic neuralgia.

Background: Postherpetic neuralgia (PHN) is the most common complication following an acute varicella zoster virus infection. PHN often results in a chronic severe pain condition refractory to conservative pain management treatments. Peripheral nerve stimulation over the affected spinal nerve root may be an effective treatment option for patients with intractable PHN.

Reliability and validity of the Global Pain Scale with chronic pain sufferers.

Background: Many pain scales exist today; however, a comprehensive, easy-to-analyze test has yet to be available to evaluate a patient's pain and understand the sociocultural, cognitive, and affective factors contributing to a patient's overall pain experience. Many scales have attempted to create an all-encompassing pain assessment but remain incomplete in their assessment of pain and the contributing aspects of pain.

Objective: To present the Global Pain Scale (GPS) as an alternative to current pain assessments and evaluate the reliability and construct validity of the GPS.

Sacral nerve stimulation as a treatment modality for intractable neuropathic testicular pain.

Chronic testicular pain, or "chronic orchalgia," is defined as testicular pain 3 months or longer in duration that significantly interferes with the daily activities of the patient. For patients failing to respond to conservative treatment, microsurgical denervation of the spermatic cord, epididymectomy, and vasovasostomy have all shown a degree of relief. However, these are all invasive procedures and no treatment has proven efficacy when these options fail.