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Leonardo Kapural,1 Janus Patel,2 Jason Charles Rosenberg,3 Sean Li,4 Kasra Amirdelfan,5 Marshall Bedder6,7 1Carolinas Pain Institute, Winston Salem, NC, USA; 2Atrium Health, Wake Forest Baptist Pain Center-Premier, Winston Salem, NC, USA; 3South Carolina Pain and Spine Specialists, Murrels Inlet, SC, USA; 4National Spine and Pain Centers, Shrewsbury, NJ, USA; 5IPM Medical Group, Walnut Creek, CA, USA; 6Department of Surgery, Pain Medicine Service, Charlie Norwood Veterans Administration Medical Center, Augusta, GA, USA; 7Department of Psychiatry and Health Behavior, Addiction Medicine Service, Wellstar/Medical College of Georgia, Augusta, GA, USACorrespondence: Leonardo Kapural, Carolinas Pain Institute, Winston-Salem, NC, 27103, USA, Email lkapuralmd@gmail.comBackground: Many of the current treatments for chronic neuropathic pain have variable effectiveness and known side effects. Given the prevalence of this type of intractable pain (3– 17% of general population), additional therapeutic non-invasive approaches are desired. Magnetic Peripheral Nerve Stimulation (mPNS) delivered at 0.5Hz provides an effective pain relief without side effects. The objective of this randomized, controlled, multi-site clinical trial was to compare long-term safety and efficacy of mPNS in patients with chronic, intractable, post-traumatic or post-surgical neuropathic pain to comprehensive Conventional Medical Management (CMM).Methods: A total of 65 patients with post-traumatic, post-surgical neuropathy were treated within a multicenter, randomized, clinical trial comparing the safety and effectiveness of mPNS + CMM to CMM alone. Patients were randomized 1:1 and followed through 90 days. The primary endpoint is a proportion of responders, 50% or greater reduction in pain at Day 90. The secondary endpoints included the European Quality of Life 5 Dimensions 3 Level (EQ-5D-3L) and Patient Global Impression of Change (PGIC).Results: At 3 months, 71% of subjects were considered responders (> 50% pain relief) in the mPNS + CMM group vs 13% of subjects in the CMM group. The mPNS + CMM group had a mean reduction in VAS scores at Day 90 of 3.8 points (> 50% reduction), while CMM showed less than a 1-point (0.7 point) mean reduction or ~10% reduction (p < 0.0001). The EQ-5D-3L score increased in the mPNS + CMM study group, whereas the CMM group showed no improvement in EQ-5D-3L at Day 90. PGIC responder rates were 80.6% and 4.3% at Day 90 for mPNS + CMM and CMM groups, respectively.Conclusion: mPNS + CMM was superior to CMM in a randomized prospective study when used for treatment of post-traumatic, post-surgical neuropathy. Due to the lack of other effective non-invasive treatments for neuropathic pain, mPNS should be considered much earlier in the treatment algorithm.Keywords: neuropathic pain, noninvasive, cost effective, pain relief, neuropathy

Dawood Sayed,1 Timothy R Deer,2,3 Vinicius Tieppo Francio,1 Christopher M Lam,1 Kamil Sochacki,4 Nasir Hussain,5 Tristan E Weaver,5 Jay Karri,6,7 Vwaire Orhurhu,8,9 Natalie Holmes Strand,10 Jacqueline Soicher Weisbein,11 Jonathan M Hagedorn,12 Ryan S D’Souza,12 Ryan R Budwany,2 Ahish Chitneni,13 Kasra Amirdelfan,14 Michael J Dorsi,15 Dan TD Nguyen,16 Christopher Bovinet,17 Alaa Abd-Elsayed18 1Anesthesiology and Pain Medicine, The University of Kansas Medical Center, Kansas City, KS, USA; 2Pain Services, Spine and Nerve Center of the Virginias, Charleston, WV, USA; 3Anesthesiology and Pain Medicine, West Virginia University School of Medicine, Charleston, WV, USA; 4Department of Anesthesiology and Perioperative Medicine, Rutgers Robert Wood Johnson, New Brunswick, NJ, USA; 5Anesthesiology, the Ohio State University Wexner Medical Center, Columbus, OH, USA; 6Department of Orthopedic Surgery, University of Maryland School of Medicine, Baltimore, MD, USA; 7Department of Anesthesiology, University of Maryland School of Medicine, Baltimore, MD, USA; 8Department of Anesthesiology, University of Pittsburgh Medical Center, Williamsport, PA, USA; 9Pain Medicine, MVM Health, East Stroudsburg, PA, USA; 10Anesthesiology and Pain Medicine, Mayo Clinic, Phoenix, AZ, USA; 11Interventional Pain Management, Napa Valley Orthopaedic Medical Group, Napa, CA, USA; 12Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN, USA; 13Department of Rehabilitation & Regenerative Medicine, New York Presbyterian – Columbia & Cornell, New York, NY, USA; 14Director of Clinical Research, Boomerang Healthcare, Walnut Creek, CA, USA; 15Neurosurgery, University of California Los Angeles, Los Angeles, CA, USA; 16Neuroradiology & Pain Solutions of Oklahoma, Edmond, OK, USA; 17The Spine Center of SE Georgia, Brunswick, GA, USA; 18Anesthesiology, University of Wisconsin, Madison, WI, USACorrespondence: Dawood Sayed, Anesthesiology and Pain Medicine, The University of Kansas Medical Center, Kansas City, KS, USA, Tel +1 785-550-5800, Email dsayed@kumc.eduAbstract: Clinical management of sacroiliac disease has proven challenging from both diagnostic and therapeutic perspectives. Although it is widely regarded as a common source of low back pain, little consensus exists on the appropriate clinical management of sacroiliac joint pain and dysfunction. Understanding the biomechanics, innervation, and function of this complex load bearing joint is critical to formulating appropriate treatment algorithms for SI joint disorders. ASPN has developed this comprehensive practice guideline to serve as a foundational reference on the appropriate management of SI joint disorders utilizing the best available evidence and serve as a foundational guide for the treatment of adult patients in the United States and globally.Keywords: sacroiliac joint, sacroiliitis, chronic pain, best practices, radiofrequency ablation, sacroiliac joint fusion

Dawood Sayed,1 Timothy Ray Deer,2 Jonathan M Hagedorn,3 Asim Sayed,4 Ryan S D’Souza,3 Christopher M Lam,1 Nasir Khatri,5 Zohra Hussaini,1 Scott G Pritzlaff,6 Newaj Mohammad Abdullah,7 Vinicius Tieppo Francio,1 Steven Michael Falowski,8 Yussr M Ibrahim,9 Mark N Malinowski,10 Ryan R Budwany,2 Natalie Holmes Strand,11 Kamil M Sochacki,12 Anuj Shah,13 Tyler M Dunn,11 Morad Nasseri,14 David W Lee,15 Leonardo Kapural,16 Marshall David Bedder,17,18 Erika A Petersen,19 Kasra Amirdelfan,20 Michael E Schatman,21,22 Jay Samuel Grider23 1Department of Anesthesiology and Pain Medicine, The University of Kansas Medical Center, Kansas City, KS, USA; 2Pain Services, Spine and Nerve Center of the Virginias, Charleston, WV, USA; 3Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN, USA; 4Podiatry/Surgery, Susan B. Allen Memorial Hospital, El Dorado, KS, USA; 5Interventional Pain Medicine, Novant Spine Specialists, Charlotte, NC, USA; 6Department of Anesthesiology and Pain Medicine, University of California, Davis, Sacramento, CA, USA; 7Department of Anesthesiology, University of Utah, Salt Lake City, UT, USA; 8Neurosurgery, Neurosurgical Associates of Lancaster, Lancaster, PA, USA; 9Pain Medicine, Northern Light Eastern Maine Medical Center, Bangor, ME, USA; 10OhioHealth Neurological Physicians, OhioHealth, Columbus, OH, USA; 11Anesthesiology and Pain Medicine, Mayo Clinic, Phoenix, AZ, USA; 12Department of Anesthesiology and Perioperative Medicine, Rutgers Robert Wood Johnson, New Brunswick, NJ, USA; 13Department of Physical Medicine and Rehabilitation, Detroit Medical Center, Detroit, MI, USA; 14Interventional Pain Medicine / Neurology, Boomerang Healthcare, Walnut Creek, CA, USA; 15Pain Management Specialist, Fullerton Orthopedic, Fullerton, CA, USA; 16Carolinas Pain Institute, Winston Salem, NC, USA; 17Chief of Pain Medicine Service, Augusta VAMC, Augusta, GA, USA; 18Associate Professor and Director, Addiction Medicine Fellowship Program, Department Psychiatry and Health Behavior, Medical College of Georgia at Augusta University, Augusta, GA, USA; 19Department of Neurosurgery, University of Arkansas for Medical Sciences, Little Rock, AR, USA; 20Director of Clinical Research, Boomerang Healthcare, Walnut Creek, CA, USA; 21Department of Anesthesiology, Perioperative Care & Pain Medicine, NYU Grossman School of Medicine, New York, NY, USA; 22Department of Population Health – Division of Medical Ethics, NYU Grossman School of Medicine, New York, NY, USA; 23Anesthesiology, Division of Pain Medicine, University of Kentucky College of Medicine, Lexington, KY, USACorrespondence: Dawood Sayed, Anesthesiology and Pain Medicine, the University of Kansas Medical Center, Kansas City, KS, USA, Tel +1 785-550-5800, Email dsayed@kumc.eduIntroduction: Painful diabetic neuropathy (PDN) is a leading cause of pain and disability globally with a lack of consensus on the appropriate treatment of those suffering from this condition. Recent advancements in both pharmacotherapy and interventional approaches have broadened the treatment options for PDN. There exists a need for a comprehensive guideline for the safe and effective treatment of patients suffering from PDN.Objective: The SWEET Guideline was developed to provide clinicians with the most comprehensive guideline for the safe and appropriate treatment of patients suffering from PDN.Methods: The American Society of Pain and Neuroscience (ASPN) identified an educational need for a comprehensive clinical guideline to provide evidence-based recommendations for PDN. A multidisciplinary group of international experts developed the SWEET guideline. The world literature in English was searched using Medline, EMBASE, Cochrane CENTRAL, BioMed Central, Web of Science, Google Scholar, PubMed, Current Contents Connect, Meeting Abstracts, and Scopus to identify and compile the evidence for diabetic neuropathy pain treatments (per section as listed in the manuscript) for the treatment of pain. Manuscripts from 2000-present were included in the search process.Results: After a comprehensive review and analysis of the available evidence, the ASPN SWEET guideline was able to rate the literature and provide therapy grades for most available treatments for PDN utilizing the United States Preventive Services Task Force criteria.Conclusion: The ASPN SWEET Guideline represents the most comprehensive review of the available treatments for PDN and their appropriate and safe utilization.Keywords: diabetes, painful diabetic neuropathy, neuropathy, spinal cord stimulation, chronic pain, diabetic neuropathy

Angela Leitner,1 Erin Hanson,1 Nicole Soliday,1 Peter Staats,2 Robert Levy,3 Jason Pope,4 Jan W Kallewaard,5,6 Daniel Doleys,7 Sean Li,2 Jacqueline Weisbein,8 Kasra Amirdelfan,9 Lawrence Poree10 1Saluda Medical Pty Ltd, Artarmon, New South Wales, Australia; 2National Spine and Pain Centers, Shrewsbury, NJ, USA; 3Departments of Neurosurgery and Clinical Research, Anesthesia Pain Care Consultants, Tamarac, FL, USA; 4Evolve Restorative Center, Santa Rosa, CA, USA; 5Department of Anaesthesiology and Pain Management, Rijnstate Hospital, Arnhem, the Netherlands; 6Department of Anesthesiology and Pain Medicine, Amsterdam University Medical Centre, Amsterdam, the Netherlands; 7Pain and Rehabilitation Institute, Birmingham, AL, USA; 8Napa Valley Orthopaedic Medical Group, Napa, CA, USA; 9Boomerang Healthcare, Walnut Creek, CA, USA; 10Department of Anesthesia and Perioperative Care, University of California at San Francisco, San Francisco, CA, USACorrespondence: Angela Leitner, Saluda Medical, Ground Floor, 407 Pacific Hwy, Artarmon, NSW, 2064, Australia, Email angela.leitner@saludamedical.comBackground: Spinal cord stimulation (SCS) is an established chronic pain treatment, but the effectiveness of traditional, open-loop paradigms has been plagued by variable sustainability in a real-world setting. A new approach, utilizing evoked compound action potential (ECAP) controlled closed-loop (CL) SCS, continuously monitors spinal cord activation and automatically adjusts the stimulation amplitude of every pulse, maintaining stimulation at the prescribed ECAP level through this continual feedback mechanism. Recent studies demonstrated the long-term safety and efficacy of ECAP-controlled CL-SCS. Here, we report the design of a prospective, multicenter, single-arm feasibility study to characterize clinical outcomes in a real-world chronic pain population utilizing ECAP-controlled CL-SCS. Objective neurophysiological measurements such as device performance and patient therapy compliance, will be analyzed against baseline biopsychosocial assessments, to explore the clinical utility of these objective physiologic biomarkers in patient phenotyping.Methods: This study will enroll up to 300 subjects with chronic, intractable trunk and/or limb pain in up to 25 United States investigation sites. Subjects meeting eligibility criteria will undergo a trial procedure and a permanent implant following a successful trial. Neurophysiological measurements (measured in-clinic and continuously during home use) and clinical outcomes including pain, quality-of-life, psychological, emotional, and functional assessments will be collected at baseline, trial end, and up to 24-months post-implantation.Discussion: Associations between objective neurophysiological data, clinical evaluation and patient-reported outcomes may have important clinical and scientific implications. They may provide novel insights about the chronic pain pathophysiology, its modulation during CL-SCS, and identification of pain phenotypes and/or mechanisms associated with treatment response during SCS trials and long-term therapy. Data from the ECAP study could lead to improvements in diagnosis, assessment, patient identification and management of chronic pain. It could also provide the foundation for development of a new SCS treatment approach customized by the patient’s pain phenotype, unique neurophysiology, and disease severity.Keywords: chronic pain, closed-loop, evoked compound action potentials, spinal cord stimulation

Kenneth B Chapman,1– 3 Dawood Sayed,4 Tim Lamer,5 Corey Hunter,6 Jacqueline Weisbein,7 Kiran V Patel,1– 3 David Dickerson,8,9 Jonathan M Hagedorn,10 David W Lee,11 Kasra Amirdelfan,12 Timothy Deer,13 Krishnan Chakravarthy14,15 1The Spine & Pain Institute of New York, New York, NY, USA; 2Department of Anesthesiology, Zucker School of Medicine at Hofstra Northwell, Manhasset, NY, USA; 3Department of Anesthesiology, NYU Langone Medical Center, New York, NY, USA; 4Department of Anesthesiology, The University of Kansas Medical Center (KUMC), Kansas City, KS, USA; 5Department of Anesthesiology and Perioperative Medicine, Division of Pain Medicine, Mayo Clinic, Rochester, MN, USA; 6Ainsworth Institute of Pain Management, New York, NY, USA; 7Napa Valley Orthopedic Medical Group, Napa, CA, USA; 8Department of Anesthesiology, Critical Care and Pain Medicine, NorthShore University Health System, Evanston, IL, USA; 9Department of Anesthesia & Critical Care, University of Chicago, Chicago, IL, USA; 10iSpine Pain Physicians, Maple Grove, MN, USA; 11Fullerton Orthopedic Surgery Medical Group, Fullerton, CA, USA; 12IPM Medical Group, Inc., Walnut Creek, CA, USA; 13The Spine and Nerve Center of the Virginias, Charleston, WV, USA; 14Department of Anesthesiology and Pain Medicine, University of California San Diego Health Sciences, San Diego, CA, USA; 15VA San Diego Healthcare System, San Diego, CA, USACorrespondence: Kenneth B Chapman, NYU Langone Medical Center, Zucker School of Medicine at Hofstra/Northwell, Pain Medicine at Staten Island University Hospital, 1360 Hylan Boulevard, Staten Island, NY, 10305, USA, Email chapmanken@spinepainny.comAbstract: With continued innovations in neuromodulation comes the need for evolving reviews of best practices. Dorsal root ganglion stimulation (DRG-S) has significantly improved the treatment of complex regional pain syndrome (CRPS), and it has broad applicability across a wide range of other conditions. Through funding and organizational leadership by the American Society for Pain and Neuroscience (ASPN), this best practices consensus document has been developed for the selection, implantation, and use of DRG stimulation for the treatment of chronic pain syndromes. This document is composed of a comprehensive narrative literature review that has been performed regarding the role of the DRG in chronic pain and the clinical evidence for DRG-S as a treatment for multiple pain etiologies. Best practice recommendations encompass safety management, implantation techniques, and mitigation of the potential complications reported in the literature. Looking to the future of neuromodulation, DRG-S holds promise as a robust intervention for otherwise intractable pain.Keywords: dorsal root ganglion, neurostimulation, chronic pain, best practice, guidelines

Dawood Sayed,1 Jay Grider,2 Natalie Strand,3 Jonathan M Hagedorn,4 Steven Falowski,5 Christopher M Lam,1 Vinicius Tieppo Francio,6 Douglas P Beall,7 Nestor D Tomycz,8 Justin R Davanzo,9 Rohit Aiyer,10 David W Lee,11 Hemant Kalia,12,13 Soun Sheen,13 Mark N Malinowski,14,15 Michael Verdolin,16 Shashank Vodapally,17 Alexios Carayannopoulos,18– 20 Sameer Jain,21 Nomen Azeem,22,23 Reda Tolba,24,25 George C Chang Chien,26,27 Priyanka Ghosh,28 Anthony J Mazzola,29 Kasra Amirdelfan,30 Krishnan Chakravarthy,31,32 Erika Petersen,33 Michael E Schatman,34,35 Timothy Deer36 1Department of Anesthesiology and Pain Medicine, The University of Kansas Medical Center, Kansas City, KS, USA; 2University of Kentucky, Lexington, KY, USA; 3Interventional Pain Management, Mayo Clinic, Scottsdale, AZ, USA; 4iSpine Pain Physicians, Maple Grove, MN, USA; 5Functional Neurosurgery, Neurosurgical Associates of Lancaster, Lancaster, PA, USA; 6Department of Rehabilitation Medicine, University of Kansas Medical Center, Kansas City, KS, USA; 7Comprehensive Specialty Care, Edmond, OK, USA; 8AHN Neurosurgery, Allegheny General Hospital, Pittsburgh, PA, USA; 9AHN Neurosurgery, Forbes Hospital, Monroeville, PA, USA; 10Interventional Pain Management and Pain Psychiatry, Henry Ford Health System, Detroit, MI, USA; 11Physical Medicine & Rehabilitation and Pain Medicine, Fullerton Orthopedic Surgery Medical Group, Fullerton, CA, USA; 12Rochester Regional Health System, Rochester, NY, USA; 13Department of Physical Medicine & Rehabilitation, University of Rochester, Rochester, NY, USA; 14Adena Spine Center, Adena Health System, Chillicothe, OH, USA; 15Ohio University Heritage College of Osteopathic Medicine, Athens, OH, USA; 16Anesthesiology and Pain Medicine, Pain Consultants of San Diego, San Diego, CA, USA; 17Physical Medicine and Rehabilitation, Michigan State University, East Lansing, MI, USA; 18Department of Physical Medicine and Rehabilitation, Rhode Island Hospital, Newport Hospital, Lifespan Physician Group, Providence, RI, USA; 19Comprehensive Spine Center at Rhode Island Hospital, Newport Hospital, Providence, RI, USA; 20Neurosurgery, Brown University, Providence, RI, USA; 21Interventional Pain Management, Pain Treatment Centers of America, Little Rock, AR, USA; 22Department of Neurology, University of South Florida, Tampa, FL, USA; 23Florida Spine & Pain Specialists, Riverview, FL, USA; 24Pain Management, Cleveland Clinic, Abu Dhabi, United Arab Emirates; 25Anesthesiology, Cleveland Clinic Lerner College of Medicine, Cleveland, OH, USA; 26Pain Management, Ventura County Medical Center, Ventura, CA, USA; 27Center for Regenerative Medicine, University Southern California, Los Angeles, CA, USA; 28Remedy Medical Group, San Francisco, CA, USA; 29Mount Sinai Health System, New York City, NY, USA; 30IPM Medical Group, Inc., Walnut Creek, CA, USA; 31Division of Pain Medicine, Department of Anesthesiology, University of California San Diego, San Diego, CA, USA; 32Va San Diego Healthcare, San Diego, CA, USA; 33Department of Neurosurgery, University of Arkansas for Medical Science, Little Rock, AR, USA; 34Department of Anesthesiology, Perioperative Care, and Pain Medicine, NYU Grossman School of Medicine, New York, New York, USA; 35Department of Population Health - Division of Medical Ethics, NYU Grossman School of Medicine, New York, New York, USA; 36The Spine and Nerve Center of the Virginias, Charleston, WV, USACorrespondence: Dawood Sayed, The University of Kansas Health System, 3901 Rainbow Blvd, Kansas City, KS, 66160, USA, Tel +1 913-588-5521, Email dsayed@kumc.eduIntroduction: Painful lumbar spinal disorders represent a leading cause of disability in the US and worldwide. Interventional treatments for lumbar disorders are an effective treatment for the pain and disability from low back pain. Although many established and emerging interventional procedures are currently available, there exists a need for a defined guideline for their appropriateness, effectiveness, and safety.Objective: The ASPN Back Guideline was developed to provide clinicians the most comprehensive review of interventional treatments for lower back disorders. Clinicians should utilize the ASPN Back Guideline to evaluate the quality of the literature, safety, and efficacy of interventional treatments for lower back disorders.Methods: The American Society of Pain and Neuroscience (ASPN) identified an educational need for a comprehensive clinical guideline to provide evidence-based recommendations. Experts from the fields of Anesthesiology, Physiatry, Neurology, Neurosurgery, Radiology, and Pain Psychology developed the ASPN Back Guideline. The world literature in English was searched using Medline, EMBASE, Cochrane CENTRAL, BioMed Central, Web of Science, Google Scholar, PubMed, Current Contents Connect, Scopus, and meeting abstracts to identify and compile the evidence (per section) for back-related pain. Search words were selected based upon the section represented. Identified peer-reviewed literature was critiqued using United States Preventive Services Task Force (USPSTF) criteria and consensus points are presented.Results: After a comprehensive review and analysis of the available evidence, the ASPN Back Guideline group was able to rate the literature and provide therapy grades to each of the most commonly available interventional treatments for low back pain.Conclusion: The ASPN Back Guideline represents the first comprehensive analysis and grading of the existing and emerging interventional treatments available for low back pain. This will be a living document which will be periodically updated to the current standard of care based on the available evidence within peer-reviewed literature.Keywords: back pain, intervention, clinical guideline, spinal cord stimulation, minimally invasive spine procedure, lumbar disorder, epidural steroid injection, radiofrequency ablation

Dawood Sayed,1 Ramana K Naidu,2,3 Kiran V Patel,4 Natalie H Strand,5 Pankaj Mehta,6 Christopher M Lam,1 Vinicius Tieppo Francio,7 Samir Sheth,8 Anthony Giuffrida,9 Brian Durkin,10 Nasir Khatri,11 Shashank Vodapally,12 Christopher O James,13 Benjamin D Westerhaus,9 Adam Rupp,7 Newaj M Abdullah,14 Kasra Amirdelfan,15 Erika A Petersen,16 Douglas P Beall,17 Timothy R Deer18 1Department of Anesthesiology and Pain Medicine, The University of Kansas Medical Center, Kansas City, KS, USA; 2Anesthesiology, California Orthopedics & Spine, Marin, CA, USA; 3Pain Management, MarinHealth Medical Center, Marin, CA, USA; 4Interventional Pain Management/ Anesthesiology, The Spine & Pain Institute of New York, New York City, NY, USA; 5Interventional Pain Management, Mayo Clinic, Scottsdale, AZ, USA; 6Clinical Research, Pain Specialists of Austin, Austin, TX, USA; 7Department of Rehabilitation Medicine, University of Kansas Medical Center, Kansas City, KS, USA; 8Interventional Pain Management, Sutter Health, Roseville, CA, USA; 9Cantor Spine Center, Paley Orthopedic and Spine Institute, Fort Lauderdale, FL, USA; 10Pain Institute of Long Island, Port Jefferson, NY, USA; 11Interventional Pain Medicine, Novant Health, Charlotte, NC, USA; 12Physical Medicine and Rehabilitation, Michigan State University, East Lansing, MI, USA; 13Department of Physical Medicine and Rehabilitation, University of Kentucky, Lexington, KY, USA; 14Pain Medicine and Anesthesiology, University of Utah, Salt Lake City, UT, USA; 15Clinical Research, IPM Medical Group, Inc, Walnut Creek, CA, USA; 16Department of Neurosurgery, University of Arkansas for Medical Science, Little Rock, AR, USA; 17Comprehensive Specialty Care, Edmond, OK, USA; 18The Spine and Nerve Center of the Virginias, Charleston, WV, USACorrespondence: Dawood Sayed, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS, 66160, USA, Tel +1 913-588-5521, Email dsayed1@yahoo.comAbstract: Chronic low back pain is a worldwide leading cause of pain and disability. Degenerative disc disease has been the presumptive etiology in the majority of cases of chronic low back pain (CLBP). More recent study and treatments have discovered that the vertebral endplates play a large role in CLBP in a term defined as vertebrogenic back pain. As the vertebral endplates are highly innervated via the basivertebral nerve (BVN), this has resulted in a reliable target in treating patients suffering from vertebrogenic low back pain (VLBP). The application of BVN ablation for patients suffering from VLBP is still in its early stages of adoption and integration into spine care pathways. BVN ablation is grounded in a solid foundation of both pre-clinical and clinical evidence. With the emergence of this therapeutic option, the American Society of Pain and Neuroscience (ASPN) identified the need for formal evidence-based guidelines for the proper identification and selection of patients for BVN ablation in patients with VLBP. ASPN formed a multidisciplinary work group tasked to examine the available literature and form best practice guidelines on this subject. Based on the United States Preventative Task Force (USPSTF) criteria for grading evidence, gives BVN ablation Level A grade evidence with high certainty that the net benefit is substantial in appropriately selected individuals.Keywords: back pain, vertebrogenic pain, lumbar degenerative disc, radiofrequency ablation, basivertebral nerve, guidelines

Dawood Sayed, 1 Kasra Amirdelfan, 2 Ramana K Naidu, 3 Oluwatodimu R Raji, 4 Steven Falowski 5 1The University of Kansas Medical Center, Kansas City, KS, USA; 2IPM Medical Group, Walnut Creek, CA, USA; 3California Orthopedics & Spine, Larkspur, CA, USA; 4Medical Device Development, San Francisco, CA, USA; 5Neurosurgical Associates of Lancaster, Lancaster, PA, USACorrespondence: Oluwatodimu R RajiThe Taylor Collaboration Attn: Richard Raji, 450 Stanyan Street, San Francisco, CA, 94117, USATel +1 510 570 7741Email richardraji@mdevdev.comPurpose: The purpose of this study was to assess the stabilizing effect of a posterior joint fixation technique using a novel cortical allograft implant in unilateral and bilateral fixation constructs. We hypothesize that fixation would reduce the joint’s range of motion during flexion-extension, axial rotation, and lateral bending loads. We also hypothesize that fixation would shift the center of the instantaneous axis of rotation during the predominant flexion-extension motions towards the implant’s location, and that this shift would be correlated with the reduction in flexion-extension range of motion.Materials and Methods: Six cadaveric sacroiliac joint specimens were tested under intact, unilateral fixation, and bilateral fixation conditions. The total range of motion (ROM) of the sacroiliac joint in flexion–extension, lateral bending, and axial rotation were evaluated by an optical tracking system, in a multidirectional flexibility pure moment model, between ± 7.5 Nm applied moment loads. The centers of the instantaneous axis of rotation (cIAR) of the sacroiliac joint were evaluated during flexion-extension loading. A correlation analysis was performed between the ROM reduction in flexion-extension upon implantation and shift of the cIAR to the graft implantation site.Results: Unilateral and bilateral fixations generated sacroiliac joint ROM reductions in flexion-extension, lateral bending, and axial rotation motions. Fixation shifted the cIAR to the graft implantation site. Reduction in the total range of motion had a moderate correlation with the shift of the cIAR.Conclusion: Our novel posterior approach presents a multifaceted mechanism for stabilizing the joint: first, by the reduction of the total range of motion in all planes of motion; second, by shifting the centers of the instantaneous axis of rotation towards the implant’s location in the predominant plane of motion, ensuring little to no motion at the implantation site, thus promoting fusion in this region.Keywords: range of motion, arthrodesis, allograft, distraction interference

David W Lee,1 Scott Pritzlaff,2,3 Michael J Jung,2,3 Priyanka Ghosh,4 Jonathan M Hagedorn,5 Jordan Tate,6 Keith Scarfo,7 Natalie Strand,8 Krishnan Chakravarthy,9,10 Dawood Sayed,11 Timothy R Deer,12 Kasra Amirdelfan13 1Fullerton Orthopedic Surgery Medical Group, Fullerton, CA, 92831, USA; 2University of California, Davis; 3Division of Pain Medicine, Sacramento, CA, USA; 4ReMedy Medical Group, San Francisco, CA, USA; 5Department of Anesthesiology and Perioperative Medicine, Division of Pain Medicine, Mayo Clinic, Rochester, MN, USA; 6Alliance Spine and Pain Centers, Canton, GA, USA; 7Warren Alpert Medical School of Brown University Department of Neurosurgery - Norman Prince Spine Institute, Rhode Island Hospital, Providence, RI, USA; 8Department of Anesthesiology and Perioperative Medicine, Division of Pain Medicine, Mayo Clinic, Phoenix, AZ, USA; 9University of California, San Diego; 10Division of Pain Medicine, San Diego, CA, USA; 11University of Kansas Medical Center, Kansas City, KS, USA; 12The Spine and Nerve Center of the Virginias, Inc., Charleston, WV, USA; 13IPM Medical Group, Inc., Walnut Creek, CA, USACorrespondence: David W LeeFullerton Orthopedic Surgery Medical Group, 680 Langsdorf Dr Suite 103, Fullerton, CA, 92831, USATel +1 714-879-0050Email lee.davidw@gmail.comAbstract: Radiofrequency neurotomy (RFN), also known as radiofrequency ablation (RFA), is a common interventional procedure used to treat pain from an innervated structure. RFN has historically been used to treat chronic facet-joint mediated pain. The use of RFN has more recently expanded beyond facet-joint mediated pain to peripherally innervated targets. In addition, there has also been the emergence of different radiofrequency modalities, including pulsed and cooled RFN. The use of RFN has been particularly important where conservative and/or surgical measures have failed to provide pain relief. With the emergence of this therapeutic option and its novel applications, the American Society of Pain and Neuroscience (ASPN) identified the need for formal evidence-based guidance. The authors formed a multidisciplinary work group tasked to examine the latest evidence-based medicine for the various applications of RFN, including cervical, thoracic, lumbar spine; posterior sacroiliac joint pain; hip and knee joints; and occipital neuralgia. Best practice guidelines, evidence and consensus grading were provided for each anatomical target.Keywords: radiofrequency neurotomy, radiofrequency ablation, pulsed ablation, cooled ablation, sacroiliac joint neurotomy, peripheral joint neurotomy, occipital neuralgia, chronic pain

Ramana K Naidu,1 Rahul Chaturvedi,2 Alyson M Engle,3 Pankaj Mehta,4 Brian Su,1 Krishnan Chakravarthy,5 Kasra Amirdelfan,6 Jeffrey Henn,7 Dawood Sayed,8 Jay Grider,9 Timothy Deer3 1California Orthopedics & Spine, Larkspur, CA, USA; 2School of Medicine, University of California – San Diego, San Diego, CA, USA; 3The Spine & Nerve Centers of the Virginias, Charleston, WV, USA; 4Pain Specialists of America, Killeen, TX, USA; 5Department of Anesthesiology, University of California – San Diego, San Diego, CA, USA; 6Integrated Pain Management, Walnut Creek, CA, USA; 7Joint Implant Surgeons of Florida, Fort Myers, FL, USA; 8Department of Anesthesiology, University of Kansas Medical Center, Kansas City, KS, USA; 9Department of Anesthesiology, University of Kentucky, Lexington, KY, USACorrespondence: Ramana K Naidu Email ramonaidu@me.comBackground: The discipline of interventional pain management has changed significantly over the past decade with an expected greater evolution in the next decade. Not only have the number of procedures increased, some of the procedures that were created for spine surgeons are becoming more facile in the hands of the interventional pain physician. Such change has outpaced academic institutions, societies, and boards. When a pain physician is in the credentialing process for novel procedure privileges, it can leave the healthcare system in a challenging situation with little to base their decision upon.Methods: This paper was developed by a consensus working group from the American Society of Pain and Neuroscience from various disciplines. The goal was to develop processes and resources to aid in the credentialing process.Results: These guidelines from the American Society of Pain and Neuroscience provide background information to help facilities create a process to appropriately credential physicians on novel procedures. They are not intended to serve as a standard or legal precedent.Conclusion: This paper serves as a guide for facilities to credential physicians on novel procedures.Keywords: interventional pain management, interventional spine care, credentialing, guidelines

Kasra Amirdelfan,1 Mindy Hong,2 Bobby Tay,3 Surekha Reddy,4 Vinay Reddy,4 Michael Yang,5 Krishn Khanna,3 Prasad Shirvalkar,6 Christopher Abrecht,7 Amitabh Gulati8 1IPM Medical Group, Walnut Creek, CA, USA; 2Hinge Health, San Francisco, CA, USA; 3Department of Orthopaedic Surgery, University of California San Francisco, San Francisco, CA, USA; 4Spine and Nerve Diagnostic Center, Roseville, CA, USA; 5Summit Pain Alliance, Santa Rosa, CA, USA; 6UCSF Weill Institute of Neurosciences University of California San Francisco, San Francisco, CA, USA; 7Department of Anesthesia and Perioperative Care, University of California San Francisco, San Francisco, CA, USA; 8Memorial Sloan Kettering Cancer Center, New York, NY, USACorrespondence: Amitabh GulatiMemorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USATel +1 212 639-2000Email amitabhgulati@gmail.comPurpose: This study aims to examine high-frequency impulse therapy (HFIT) impact on pain and function among patients undergoing care for chronic low back pain (CLBP).Methods: A pilot randomized-controlled trial of HFIT system versus sham was conducted across 5 orthopedic and pain center sites in California, USA. Thirty-six patients seeking clinical care for CLBP were randomized. Primary outcome was function measured by the Six Minute Walk Test (6MWT). Secondary outcomes were function (Timed Up and Go [TUG] and Oswestry Disability Index [ODI]), pain (Numerical Rating Scale [NRS]), quality of life (Patient Global Impression of Change [PGIC]), and device use. Patients were assessed at baseline and every week for 4 weeks of follow-up. Mann–Whitney U-test was used to analyze changes in each outcome. Repeated measures ANOVA was used to assess the effect of treatment over time.Results: The average age of subjects was 53.9 ± 15.7 (mean ± SD) years, with 12.1 ± 8.8 years of chronic low back pain. Patients who received an HFIT device had a significantly higher 6MWT score at weeks 2 [Cohen’s d (95% CI): 0.33 (0.02, 0.61)], 3 [0.32 (0.01, 0.59)] and 4 [0.31 (0.01, 0.60)], respectively, as compared to their baseline scores (p < 0.05). Patients in the treatment group had significantly lower TUG scores at week 3 [0.30 (0.04, 0.57)] and significantly lower NRS scores at weeks 2 [0.34 (0.02, 0.58)] and 4 [0.41 (0.10, 0.67)] (p < 0.05).Conclusion: A larger-scale RCT can build on the findings of this study to test whether HFIT is effective in reducing pain and improving function in CLBP patients. This study shows encouraging evidence of functional improvement and reduction in pain in subjects who used HFIT. The efficacy and minimally invasive nature of HFIT is anticipated to substantially improve the management of CLBP patients.Keywords: HFIT, pain, chronic pain, neuromodulation, noninvasive treatment

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. We aimed to identify neurophysiologic dose metrics and their ranges that resulted in clinically meaningful treatment responses., Materials and Methods: Subjects from 3 clinical studies (n = 180) with baseline back and leg pain ≥60 mm visual analog scale and physical function in the severe to crippled category were included. Maximal analgesic effect (MAE) was operationally defined as the greatest percent reduction in pain intensity or as the greatest cumulative responder score (minimal clinically important differences [MCIDs]) obtained within the first 3 months of SCS implant. The physiologic metrics that produced the MAE were analyzed., Results: We showed that a neural dose regimen with a high neural dose accuracy of 2.8μV and dose ratio of 1.4 resulted in a profound clinical benefit to chronic pain patients (MAE of 79 ± 1% for pain reduction and 12.5 ± 0.4 MCIDs). No differences were observed for MAE or neurophysiological dose metrics between the trial phase and post-implant MAE visit., Conclusion: For the first time, an evidence-based neural dose regimen is available for a neurostimulation intervention as a starting point to enable optimization of clinical benefit, monitoring of adherence, and management of the therapy., Competing Interests: Conflict of Interest Robert M. Levy is an uncompensated consultant for Biotronik, Abbott, Nalu, Saluda, and Mainstay Medical and has stock options from Nalu and Saluda Medical. Nagy A. Mekhail reports receiving grants from Neuros, Mesoblast, and Vivex Biologics, as well as consulting as a medical monitor for Saluda Medical, Nevro, Vivex Biologics, Mainstay, Presidio Medical, and Vertos outside the submitted work. Leonardo Kapural reports receiving grants from Nevro, Neuros, Avanos, Medtronic, Neuralace, and Xalud Therapeutics and financial support from Nevro, Avanos, and Saluda Medical outside the submitted work. Christopher A. Gilmore reports personal fees and other assistance from SPR, and personal fees from Nevro, Nalu, Biotronik, Boston Scientific, and Saluda Medical outside the submitted work. Erika A. Petersen has received research support from Mainstay, Medtronic, Neuros Medical, Nevro Corp, ReNeuron, SPR, and Saluda Medical outside the submitted work, as well as personal fees from Abbott Neuromodulation, Biotronik, Medtronic Neuromodulation, Nalu, Neuros Medical, Nevro, Presidio Medical, Saluda Medical, and Vertos outside the submitted work. She holds stock options from SynerFuse and neuro42. Jonathan H. Goree is a consultant for Saluda Medical, Abbott, and Stratus Medical outside the submitted work. He has received research support paid to the institution by SPR Therapeutics and Mainstay Medical. Jason E. Pope reports research and consulting fees from Saluda Medical during the conduct of the study; stock options from Saluda Medical; consultancy for Abbott, Medtronic, Saluda Medical, Flowonix, SpineThera, Vertos, Vertiflex, SPR Therapeutics, Tersera, Aurora, Spark, Ethos, Biotronik, Mainstay, WISE, Boston Scientific, and Thermaquil outside the submitted work; has received grant and research support from Abbott, Flowonix, Aurora, Painteq, Ethos, Muse, Boston Scientific, SPR Therapeutics, Mainstay, Vertos, AIS, and Thermaquil outside the submitted work; and is a minority shareholder of Vertos, Stimgenics, SPR Therapeutics, Painteq, Aurora, Spark, Celeri Health, Neural Integrative Solutions, Pacific Research Institute, Thermaquil, Abbott and Anesthetic Gas Reclamation. Shrif J. Costandi reports receiving grants from Saluda Medical, Vertos, Mainstay, and Vivex outside the submitted work. Jan Willem Kallewaard is an advisory board member for Boston Scientific, Medtronic, Abbott, and Saluda Medical. Simon Thomson has received consultancy fees from Boston Scientific, Mainstay Medical, and Saluda Medica outside the submitted work. He has received department research funding from the National Institute for Health Research, Boston Scientific, Saluda Medical, and Mainstay Medical. Christopher Gilligan reports consulting fees and stock options received from Mainstay, personal fees from Mainstay, Saluda Medical, Persica, and Iliad outside the submitted work, research funded by Sollis, expert witness testimony fees, and serves as Editor-in-Chief of Pain Practice. Corey W. Hunter has received consultancy fees from Saluda Medical and Genecentrix outside the submitted work. Kasra Amirdelfan reports consultancy for Medtronic, Nevro, Boston Scientific, Nalu, Presidio, Biotronik, Mesoblast, and Vivex Laboratories outside the submitted work. Steven M. Falowski reports consulting fees from Abbott, Medtronic, Saluda, VertiFlex, Vertos, Surgentec, CornerLoc, Mainstay, and Relievant outside the submitted work, has received a grant for research funding from Mainstay, Relievant, Medtronic, Abbott, VertiFlex, Saluda, Nalu, CornerLoc, Aurora, Biotronik, and Stimgenics outside the submitted work, and has an equity position in SynerFuse, Aurora Spine, Thermaquil. SPR Therapeutics, Saluda, CornerLoc, PainTEQ, Stimgenics, Anesthetic Gas Reclamation, Neural Integrative Solutions, SpineThera, and Celeri Health. Sean Li reports receiving grants and personal fees from Saluda Medical during the conduct of the study; he reports grants from Avanos, Nalu Medical, SPR Therapeutics, Averitas Pharma, Biotronik, Neuralace, Presidio, SGX Therapeutics, and PainTeq, as well as consultancy for Abbott, Avanos, Presidio, SPR Therapeutics, Averitas Pharma, Biotronik, Nalu Medical, PainTeq, and Vertos Medical outside the submitted work, as well as holding stock options for Nalu Medical and NeuroOne. Shivanand P. Lad reports personal fees from Mainstay Medical and Nevro outside the submitted work; he is a consultant for Abbott Laboratories, Boston Scientific, Higgs Boson Health, Medtronic, Minnetronix, Nevro, and Presidio Medical. Dawood Sayed reports personal fees from Abbott, Boston Scientific, Flowonix, Medtronic, Nevro, Saluda, and Vertiflex outside the submitted work, personal fees and stock options from Mainstay, SPR Therapeutics, PainTEQ, and Vertos, and stock options from Neuralace and Surgentec. Ajay Antony reports consultancy fees from Boston Scientific outside the submitted work. Timothy R. Deer reports consultancy for Axonics, Abbott, Nalu, Vertos, SpineThera, Mainstay, Cornerloc, Ethos, SPR Therapeutics, Medtronic, Boston Scientific, PainTeq, Saluda Medical, Tissue Tech, Spinal Simplicity, and Avanos outside the submitted work. Maged N. Guirguis has received consulting fees from Avanos Medical, Avertis Pharmacy, Boston Scientific, and Saluda Medical outside the submitted work, as well as research support from Boston Scientific, Neuros Medical, Nevro Corp, and Saluda Medical outside the submitted work. Aaron K. Calodney reports personal fees from Medtronic, Nevro, Stryker, PainTeq, Saluda Medical, and Boston Scientific outside the submitted work. Brian Bruel reports consultancy for Saluda Medical, Boston Scientific, Spinal Simplicity, Biotronik, TerSera, Stratus, and Neurovasis outside the submitted work. Patrick Buchanan reports consulting fees from Saluda Medical, Abbott, and PainTEQ outside the submitted work. Nicole Soliday, Rui V. Duarte, and Angela Leitner report being employees of Saluda Medical. Peter S. Staats has received consultancy fees from Medtronic, Saluda Medical, Nalu, and Biotronic outside the submitted work, and has stock options from Saluda Medical and Nalu. The remaining authors report no conflict of interest., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Preventing disc degeneration remains a clinical challenge; patients experiencing chronic lumbar discogenic pain have limited treatment options. Minimally invasive intradiscal procedures such as allogeneic nucleus pulposus (NP) injection have the potential to fill the treatment gap between failed conservative care and spine surgery., Objectives: Our study sought to evaluate the magnitude and durability of improvement in back function in patients with chronic lumbar discogenic pain followed for 6 months after a single intradiscal injection of minimally manipulated, off-the-shelf processed NP allograft (VIA Disc NP®, VIVEX Biologics, Inc.) at up to 2 vertebral levels., Study Design: Single-arm, prospective, multicenter, pilot study., Setting: Academic and private practice outpatient clinics., Methods: A total of 29 patients with symptomatic lumbar discogenic pain refractory to conservative care who had a back function score of  40-80 points on the Oswestry Disability Index (ODI), ≥ 6 on an 11-point back pain Numeric Rating Scale (NRS-11) and corresponding imaging evidence of disc degeneration were enrolled. A single dose, intradiscal injection of approximately 100 mg of NP allograft mixed with sterile saline was administered to the affected level or levels., Results: The average ODI and NRS-11 improvements between baseline and 6-months postprocedure were 54.8% (95% CI, 41.3-68.3) and 52.9% (95% CI, 34.7-71.1) respectively (P < 0.001). A minimal clinically important difference of ≥ 30% improvement over baseline was achieved in 79% (22 of 28) and 68% (19 of 28) of patients for ODI and NRS-11, respectively. At 6-months postprocedure, 64% (18 of 28) of patients had an NRS-11 score ≥ 3., Limitations: This pilot study did not employ a concurrent control group and the clinical follow-up was limited to 6 months., Conclusions: These pilot findings demonstrate the feasibility of treating patients with symptomatic lumbar disc degeneration with a single intradiscal injection of allogeneic NP to provide significant and durable improvements in back function and pain.

Background: Measures of therapeutic efficacy in pain studies have historically focused on pain scores, such as the Visual Analog Scale (VAS) or the Numeric Rating Scale. However, pain scores capture a univariate measure of a multivariate condition present in patients with chronic pain, where the pain condition can affect activities of daily living, sleep, quality of life, and mood. Hence, examining composite endpoints, which incorporate outcomes from multiple facets of pain, may allow investigators to better assess improvements in chronic pain patients with various new treatments., Objectives: This trial was designed to evaluate the performance of the Nalu™ Neurostimulation System (Nalu Medical, Inc.), a miniature implanted pulse generator (micro-IPG), in the treatment of low-back pain and leg pain with spinal cord stimulation therapy., Study Design: This was a prospective, single arm, multicenter, open-label, postmarket study that followed patients for 90 days postimplantation of the Nalu Neurostimulation System., Setting: Patients were recruited from, and treated at, 15 US-based comprehensive pain centers., Methods: Patients with chronic, intractable, neuropathic pain of the back and/or leg(s), with a VAS pain score of at least 6 at the time of screening, were included. The micro-IPG was implanted per standard clinical practice. Patient-reported outcomes (PROs), including VAS pain scores, Oswestry Disability Index (ODI), Beck Depression Inventory, quality-of-life metric (EQ-5D-5L), Patient Global Impression of Change (PGIC), and sleep disturbance Patient-reported Outcomes Measurement Information System (PROMIS) were recorded. Literature-based minimal clinically important differences (MCIDs) were used to define the MCID responder rates as well as a composite endpoint analysis., Results: Ninety-four percent (94%) of the study patients reached the MCID in at least 2 of the PROs. Five out of 6 PROs demonstrated a responder rate of > 75%. Forty-nine percent (49%) of the patients were holistic responders, meaning they responded in each of the 6 outcome measures under consideration. Overall VAS pain scores reached the MCID in 86% of the patients. PGIC demonstrated the largest MCID responder rate: 100%. The ODI score reached the MCID in 94% of the patients; the BDI score reached the MCID rate in 84% of the patients; the EQ-5D-5L score reached the MCID in 77% of the patients; and the PROMIS score reached the MCID in 67% of the patients., Limitations: While this was a multicenter, prospective study, it was also a single arm, nonrandomized trial. The 35 study patients were only followed for 90 days post micro-IPG implant., Conclusion: In the face of improving spinal cord stimulation pain outcomes, composite PROs are likely to become more common in evaluating therapeutic response. Responder rates, defined by the MCID, may help to establish composite endpoints. Since MCID was achieved across a variety of endpoints indicates that treatment with the Nalu Neurostimulation System provided a robust treatment response.

Background: The SENZA-PDN study evaluated high-frequency 10-kHz spinal cord stimulation (SCS) for the treatment of painful diabetic neuropathy (PDN). Over 24 months, 10-kHz SCS provided sustained pain relief and improved health-related quality of life. This report presents additional outcomes from the SENZA-PDN study, focusing on diabetes-related pain and quality of life outcomes., Methods: The SENZA-PDN study randomized 216 participants with refractory PDN to receive either conventional medical management (CMM) or 10-kHz SCS plus CMM (10-kHz SCS + CMM), allowing crossover after six months if pain relief was insufficient. Postimplantation assessments at 24 months were completed by 142 participants with a permanent 10-kHz SCS implant, comprising 84 initial and 58 crossover recipients. Measures included the Brief Pain Inventory for Diabetic Peripheral Neuropathy (BPI-DPN), Diabetes-Related Quality of Life (DQOL), Global Assessment of Functioning (GAF), and treatment satisfaction., Results: Over 24 months, 10-kHz SCS treatment significantly reduced pain severity by 66.9% ( P < .001; BPI-DPN) and pain interference with mood and daily activities by 65.8% ( P < .001; BPI-DPN). Significant improvements were also observed in overall DQOL score ( P < .001) and GAF score ( P < .001), and 91.5% of participants reported satisfaction with treatment., Conclusions: High-frequency 10-kHz SCS significantly decreased pain severity and provided additional clinically meaningful improvements in DQOL and overall functioning for patients with PDN. The robust and sustained benefits over 24 months, coupled with high participant satisfaction, highlight that 10-kHz SCS is an efficacious and comprehensive therapy for patients with PDN., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: EAP has received consulting fees from Abbott Laboratories, Biotronik, Boston Scientific, Medtronic Neuromodulation, Nalu Medical, Neuros Medical, Nevro Corp, Presidio Medical, Saluda, and Vertos Medical; research support from Mainstay, Medtronic Neuromodulation, Nalu Medical, Neuros Medical, Nevro Corp, ReNeuron, Saluda, and SPR; and stock options from neuro42 and SynerFuse. TGS has received research support from Nevro Corp. JAS has received research support from Boston Scientific, Nevro Corp, Saluda Medical, and Vertiflex. MJJ is an employee of Nevro Corp. DRE received a fee from Nevro Corp for the preparation of this manuscript in her capacity as an independent medical writer. JLW has received consulting fees from California Institute for Biomedical Research and Eli Lilly and research support from Nevro Corp. SMS has received research support from Nevro Corp. KA has received consulting fees from Biotronik, Medtronic, Nalu Medical, Nevro Corp, and Saluda Medical, as well as research support from Biotronik, IPM Medical Group, Nevro Corp, Saluda Medical, SPR Therapeutics, and Vivex Biologics. MNG has received consulting fees from Abbott Laboratories, Avanos Medical, Avertis Pharmacy, Boston Scientific, Nevro Corp, and Saluda Medical, as well as research support from Abbott Laboratories, Avanos Medical, Boston Scientific, Nalu Medical, Neuros Medical, Nevro Corp, and Saluda Medical. JX has received research support from the Cleveland Clinic Velosano Program, the National Institutes of Health, the Steve and Melody Golding Foundation, and Nevro Corp. CY has received research support from Nevro Corp. AN has received consulting fees from Aurora Spine, Flowonix, and Nevro Corp, as well as research support from Nevro Corp. DGP has received consulting fees from Abbott Laboratories, AIS Healthcare, Allergan, Amgen, Aurora Spine, CornerLoc, Flowonix, Lundbeck, Pajunk Medical, Saluda Medical, Spark Biomedical, and Vertos Medical; research support from Abbott Laboratories, Aurora Spine, Flowonix, Nevro Corp, and Saluda Medical; speakers’ bureau or honoraria from Abbott Laboratories, Allergan, Amgen, CornerLoc, Lundbeck, Saluda Medical, and Vertos Medical; and stock options from CornerLoc. MJC has received research support from Nevro Corp. VG has received research support from Biotronik, Medtronic, Nevro Corp, PainTEQ, SPR Therapeutics, and St. Jude. RHB has received research support from Nevro Corp. NDM has received consulting fees from Averitas, Nevro Corp, and Salix Pharmaceuticals, as well as research support from Boston Scientific and Nevro Corp. DS has received consulting fees from Abbott Laboratories, Boston Scientific, Flowonix, Medtronic, Nevro Corp, Vertiflex, and Vertos Medical, as well as research support from Abbott Laboratories, Biotronik, Nevro Corp, Vertiflex, and Vertos Medical. SPL has received consulting fees from Nevro Corp and research support from Nevro Corp. DJD has received research support from Nevro Corp, as well as funding for serving as principal investigator of a study supported by SPR Therapeutics paid to his institution. KAS has received research support from Nevro Corp. JHG has received consulting fees from Abbott Laboratories, Saluda Medical, and Stratus Medical. PWW has received research support from Nevro Corp. CEA has received consulting fees from AbbVie, Amgen, Biohaven, Clexio Biosciences, Collegium, Eli Lilly, Elsevier, Flowonix, Gene Pharma, Lundbeck, Nevro Corp, Novartis, Pfizer, SK Life Science, Teva Pharmaceutical, and Vertex, as well as research support from AbbVie, Allergan, Amgen, Daiichi Sankyo, Eli Lilly, Novartis, Teva Pharmaceutical, and Vertex Pharmaceuticals. CEN has received consulting fees from Exelixis, Neurogastrx, and Nevro Corp, as well as research support from Nevro Corp. RST has received consulting fees from Nevro Corp, Medtronic, and Saluda Medical. DLC is an employee of Nevro Corp. NAM has received consulting fees from Nevro Corp, Relievant Medsystems, Saluda Medical, Sollis Therapeutics, and Vertos Medical, as well as research support from Avanos Medical, Mesoblast, Neuros Medical, and Nevro Corp.

Introduction: Energy-reducing spinal cord stimulation (SCS) approaches have the potential to impact patient experience with rechargeable and non-rechargeable SCS devices through reducing device recharge time or enhancing device longevity. This prospective, multi-center study evaluated the safety, effectiveness, and actual energy usage of differential target multiplexed (DTM) endurance therapy, a reduced energy DTM SCS derivative., Methods: Subjects who reported an overall pain visual analog score (VAS) of ≥6/10 cm and an Oswestry Disability Index score of 21-80 out of 100 at baseline with moderate to severe chronic, intractable back and/or leg pain were eligible. Evaluation visits occurred at 1, 3, 6, and 12 months post-device activation. The primary objective was to characterize change in overall pain intensity, as measured by VAS, from baseline to 3-month visit., Results: Fifty-seven subjects enrolled at 12 US sites from November 2020 through June 2021, 35 were implanted with a rechargeable SCS device, and 27 completed the 12-month visit. Subjects experienced a 50.4% mean reduction in overall pain from baseline at the 3-month follow-up that was sustained through 12 months. Additional outcomes including changes in overall, back, and leg pain intensity, quality of life, disability, therapy satisfaction, safety, and current battery usage are shown through 12-month follow-up., Conclusion: The use of DTM endurance SCS therapy in this study resulted in reductions in pain relief through 12 months, demonstrating that energy-reducing stimulation patterns can provide clinical benefit. Clinically effective, reduced energy SCS derivatives have the potential to impact patient experience through either reduced recharge requirements or increased device longevity., (© 2024 Medtronic and The Author(s). Pain Practice published by Wiley Periodicals LLC on behalf of World Institute of Pain.)

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. Participants with chronic, intractable back and leg pain refractory to conservative therapy were enrolled between January 2017 and February 2018, with follow-up through 36 months. The primary outcome was a reduction of at least 50% in overall back and leg pain. Holistic treatment response, a composite outcome including pain intensity, physical and emotional functioning, sleep, and health-related quality of life, and objective neural activation was also assessed., Results: At 36 months, more CL-SCS than OL-SCS participants reported ≥50% reduction (CL-SCS=77.6%, OL-SCS=49.3%; difference: 28.4%, 95% CI 12.8% to 43.9%, p<0.001) and ≥80% reduction (CL-SCS=49.3%, OL-SCS=31.3%; difference: 17.9, 95% CI 1.6% to 34.2%, p=0.032) in overall back and leg pain intensity. Clinically meaningful improvements from baseline were observed at 36 months in both CL-SCS and OL-SCS groups in all other patient-reported outcomes with greater levels of improvement with CL-SCS. A greater proportion of patients with CL-SCS were holistic treatment responders at 36-month follow-up (44.8% vs 28.4%), with a greater cumulative responder score for CL-SCS patients. Greater neural activation and accuracy were observed with CL-SCS. There were no differences between CL-SCS and OL-SCS groups in adverse events. No explants due to loss of efficacy were observed in the CL-SCS group., Conclusion: This long-term evaluation with objective measurement of SCS therapy demonstrated that ECAP-controlled CL-SCS resulted in sustained, durable pain relief and superior holistic treatment response through 36 months. Greater neural activation and increased accuracy of therapy delivery were observed with ECAP-controlled CL-SCS than OL-SCS., Trial Registration Number: NCT02924129., Competing Interests: Competing interests: NM reports personal fees from Saluda Medical for acting as independent medical monitor for the EVOKE study during the conduct of the study; he reports receiving grants from Neuros and Mesoblast, as well as consulting as a medical monitor for Nevro, Vivex, Mainstay, and Vertos outside the submitted work. RL is an uncompensated consultant for Nalu, Saluda Medical, and Mainstay Medical and has stock options from Nalu and Saluda Medical obtained before 2019, not exercisable through the duration of his term as International Neuromodulation Society President and editor-in-chief of the journal Neuromodulation: Technology at the Neural Interface. TD reports personal fees from Saluda Medical during the conduct of the study; consultancy for Axonics, Abbott, Nalu, Vertos, SpineThera, Mainstay, Cornerloc, Ethos, SPR Therapeutics, Medtronic, Boston Scientific, PainTeq, Tissue Tech, Spinal Simplicity, and Avanos outside the submitted work. He is a minor equity holder for Saluda Medical, Nalu, SpineThera, Stimgenics, Vertiflex, Vertos, and Bioness and an advisory board member for Abbott, Vertos, Nalu, SPR Therapeutics, and Tissue Tech. LK reports receiving grants from Nevro, Neuros, Avanos, Medtronic, Neuralace, and Xalud Therapeutics and financial support from Nevro, Avanos, and Saluda Medical outside the submitted work. SL reports receiving grants and personal fees from Saluda Medical during the conduct of the study; he reports grants from Avanos, Boston Scientific, Nalu Medical, SPR Therapeutics, Averitas Pharma, Biotronik, SGX Therapeutics, and PainTeq, as well as consultancy for Abbott, Avanos, Boston Scientific, Nevro, SPR Therapeutics, Averitas Pharma, Biotronik, Nalu Medical, and PainTeq, outside the submitted work, as well as holding stock options for Nalu Medical. KA reports consultancy for Medtronic, Nevro, Boston Scientific, Nalu, Presidio, Biotronik, Mesoblast, Vivex Laboratories outside the submitted work. JP reports research and consulting fees from Saluda Medical during the conduct of the study; consultancy for Abbott, Medtronic, Saluda Medical, Flowonix, SpineThera, Vertos, Vertiflex, SPR Therapeutics, Tersera, Aurora, Spark, Ethos, Biotronik, Mainstay, WISE, Boston Scientific, and Thermaquil outside the submitted work; has received grant and research support from: Abbott, Flowonix, Aurora, Painteq, Ethos, Muse, Boston Scientific, SPR Therapeutics, Mainstay, Vertos, AIS, and Thermaquil outside the submitted work; and is a shareholder of Vertos, SPR Therapeutics, Painteq, Aurora, Spark, Celeri Health, Neural Integrative Solutions, Pacific Research Institute, Thermaquil, and Anesthetic Gas Reclamation. CH reports grants from Saluda Medical during the conduct of the study; consultancy fees from Genecentrix outside the submitted work. SC reports grants from Cleveland Clinic during the conduct of the study; and grants from Vertos, Mainstay, and Vivex outside the submitted work. SMF reports consulting fees from Abbott, Medtronic, Saluda, VertiFlex, Vertos, Surgentec, CornerLoc, Mainstay and Relievant outside the submitted work, has received grant for research funding from Mainstay, Relievant, Medtronic, Abbott, VertiFlex, Saluda, Nalu, CornerLoc, Aurora, Biotronik, and Stimgenics outside the submitted work, and has an equity position in SynerFuse, Aurora Spine, Thermaquil. SPR Therapeutics, Saluda, CornerLoc, PainTEQ, Stimgenics, Anesthetic Gas Reclamation, Neural Integrative Solutions, SpineThera, and Celeri Health. CG reports clinical trial funding from Saluda Medical during the conduct of the study; reports personal fees and other from SPR, and personal fees from Nevro, Nalu, Biotronik, and Boston Scientific outside the submitted work. PSS has received consultancy fees from Medtronic, Saluda Medical, Nalu, and Biotronic outside the submitted work, and has stock options from Saluda Medical and Nalu. JS reports personal fees from Nevro during the conduct of the study and personal fees from Saluda Medical and Boston Scientific outside the submitted work. TM reports research fees from Saluda Medical during the conduct of the study and personal fees from Nevro outside the submitted work. JC reports personal fees from Saluda Medical during the conduct of the study; personal fees from Abbott, Boston Scientific, Nevro, Medtronic, Mainstay, SPR Therapeutics, CornerLoc, PillNurse, Biotronik, and Vivex outside the submitted work; and stock from Mainstay, CornerLoc, and PillNurse. EP has received research support from Mainstay, Medtronic, Neuros Medical, Nevro Corp, ReNeuron, SPR, and Saluda Medical outside the submitted work, as well as personal fees from Abbott Neuromodulation, Biotronik, Medtronic Neuromodulation, Nalu, Neuros Medical, Nevro, Presidio Medical, Saluda Medical, and Vertos outside the submitted work. She holds stock options from SynerFuse and neuro42. JMH reports consulting fees from Abbott, Boston Scientific, Nevro, and Saluda Medical outside the submitted work. RR reports grants from SPR, Nalu and Nevro outside the submitted work,l fees from Presidio, and grants and personal fees from Boston Scientific and Saluda Medical outside the submitted work. JWK is an advisory board member for Boston Scientific, Medtronic, Abbott, and Saluda Medical. GB reports consulting fees from Medtronic, Boston Scientific, and Saluda Medical outside the submitted work, and has a consulting agreement and is on the advisory board for Nevro Corp, Nalu Medical Inc, Abbott, and Boston Scientific. RST reports consulting fees from Medtronic, Nevro and Saluda Medical outside the submitted work. LP reports personal fees from Saluda Medical; is a member of the data monitoring board of Saluda Medical during the conduct of the study; and reports personal consulting fees from Medtronic and Nalu outside the submitted work. Members of the EVOKE study group report being employees of Saluda Medical. No other disclosures were reported., (© American Society of Regional Anesthesia & Pain Medicine 2024. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ.)

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., Methods: 41 patients randomized to CL-SCS remained in their treatment allocation and were followed up through 36 months. Objective neurophysiological data, including measures of spinal cord activation, were analyzed. Pain relief was assessed by determining the proportion of patients with ≥50% and ≥80% reduction in overall back and leg pain., Results: The performance of the feedback loop resulted in high-dose accuracy by keeping the elicited ECAP within 4µV of the target ECAP set on the system across all timepoints. Percent time stimulating above the ECAP threshold was >98%, and the ECAP dose was ≥19.3µV. Most patients obtained ≥50% reduction (83%) and ≥80% reduction (59%) in overall back and leg pain with a sustained response observed in the rates between 3-month and 36-month follow-up (p=0.083 and p=0.405, respectively)., Conclusion: The results suggest that a physiological adherence to supra-ECAP threshold therapy that generates pain inhibition provided by ECAP-controlled CL-SCS leads to durable improvements in pain intensity with no evidence of loss of therapeutic effect through 36-month follow-up., Competing Interests: Competing interests: NM reports personal fees from Saluda Medical for acting as independent medical monitor for the EVOKE study during the conduct of the study; he reports receiving research grants from Neuros, Mesoblast, and Vivex Biologics, as well as consulting as a medical monitor of Nevro, Vivex Biologics, Mainstay, Sollis Therapeutics, and Vertos outside the submitted work. RL is an uncompensated consultant of Biotronik, Abbott, Nalu, Saluda, and Mainstay Medical and has stock options from Nalu and Saluda Medical. TD reports personal fees from Saluda Medical during the conduct of the study and consultancy for Axonics, Abbott, Nalu, Vertos, SpineThera, Mainstay, CornerLoc, Ethos, SPR Therapeutics, Medtronic, Boston Scientific, PainTEQ, Tissue Tech, Spinal Simplicity, and Avanos outside the submitted work. He is a minor equity holder of Saluda Medical, Nalu, SpineThera, Stimgenics, Vertiflex, Vertos, and Bioness and an advisory board member of Abbott, Vertos, Nalu, SPR Therapeutics, and Tissue Tech. LK reports receiving grants from Nevro, Neuros, Avanos, Medtronic, Neuralace, and Xalud Therapeutics and financial support from Nevro, Avanos, and Saluda Medical outside the submitted work. SL reports receiving grants and personal fees from Saluda Medical during the conduct of the study; he reports grants from Avanos, Boston Scientific, Nalu Medical, SPR Therapeutics, Averitas Pharma, Biotronik, SGX Therapeutics, and PainTEQ, as well as consultancy for Abbott, Avanos, Boston Scientific, Nevro, SPR Therapeutics, Averitas Pharma, Biotronik, Nalu Medical, and PainTEQ, outside the submitted work, as well as holding stock options for Nalu Medical. KA reports consultancy for Medtronic, Nevro, Boston Scientific, Nalu, Presidio, Biotronik, Mesoblast, and Vivex Laboratories outside the submitted work. CH reports grants from Saluda Medical during the conduct of the study and consultancy fees from Genecentrix outside the submitted work. SC reports research grants from Saluda Medical to the Cleveland Clinic during the conduct of the study and grants from Vertos, Mainstay, and Vivex outside the submitted work. SMF reports consulting fees from Abbott, Medtronic, Saluda, VertiFlex, Vertos, Surgentec, CornerLoc, Mainstay, and Relievant outside the submitted work; has received grant for research funding from Mainstay, Relievant, Medtronic, Abbott, VertiFlex, Saluda, Nalu, CornerLoc, Aurora, Biotronik, and Stimgenics outside the submitted work; and has an equity position in SynerFuse, Aurora Spine, Thermaquil, SPR Therapeutics, Saluda, CornerLoc, PainTEQ, Stimgenics, Anesthetic Gas Reclamation, Neural Integrative Solutions, SpineThera, and Celeri Health. JP reports research and consulting fees from Saluda Medical during the conduct of the study and consultancy for Abbott, Medtronic, Saluda Medical, Flowonix, SpineThera, Vertos, Vertiflex, SPR Therapeutics, Tersera, Aurora, Spark, Ethos, Biotronik, Mainstay, WISE, Boston Scientific, and Thermaquil outside the submitted work; has received grant and research support from Abbott, Flowonix, Aurora, PainTEQ, Ethos, Muse, Boston Scientific, SPR Therapeutics, Mainstay, Vertos, AIS, and Thermaquil outside the submitted work; and is a shareholder of Vertos, SPR Therapeutics, PainTEQ, Aurora, Spark, Celeri Health, Neural Integrative Solutions, Pacific Research Institute, Thermaquil, and Anesthetic Gas Reclamation. CG reports clinical trial funding from Saluda Medical during the conduct of the study and reports personal fees and others from SPR and personal fees from Nevro, Nalu, Biotronik, and Boston Scientific outside the submitted work. PSS has received consultancy fees from Medtronic, Saluda Medical, Nalu, and Biotronic outside the submitted work and has stock options from Saluda Medical and Nalu. JS reports personal fees from Nevro during the conduct of the study and personal fees from Saluda Medical and Boston Scientific outside the submitted work. TM reports research fees from Saluda Medical during the conduct of the study and personal fees from Nevro outside the submitted work. RR reports grants from SPR, Nalu, and Nevro outside the submitted work, personal fees from Presidio, and grants and personal fees from Boston Scientific and Saluda Medical outside the submitted work. RD, NS, AL, EH, ZO, and DM report being employees of Saluda Medical. LP reports personal fees from Saluda Medical, is a member of the data monitoring board of Saluda Medical during the conduct of the study, and reports personal consulting fees from Medtronic and Nalu outside the submitted work. No other disclosures were reported., (© American Society of Regional Anesthesia & Pain Medicine 2024. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ.)

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., Materials and Methods: This multicenter study was conducted at seven US sites. A total of 43 patients with low back and/or leg pain who completed a percutaneous commercial SCS trial were enrolled. Test stimulation was delivered through trial leads for approximately 90 minutes before removal. SCS parameters, including amplitude, frequency, pulse width (PW), electrode configuration, cycling, and multifrequency stimulation were varied during testing. Paresthesia threshold (PT), comfort level (CL), perceptual coverage area, and paresthesia quality (through patient selection of keywords) were collected. Differences were evaluated with analysis of variance followed by post hoc multiple comparisons using t-tests with Bonferroni correction., Results: PT was primarily determined by PW and was insensitive to frequency for constant frequency stimulation (range: 20 Hz-10 kHz; F(1284) = 69.58, p < 0.0001). For all tests, CL was approximately 25% higher than PT. The dominant variable that influenced paresthesia quality was frequency. Sensations described as comfortable and tingling were most common for frequencies between 60 Hz and 2.4 kHz; unpleasant sensations were generally more common outside this range. Increasing distance between active electrodes from 7 mm to 14 mm, or cycling the SCS waveform at 1 Hz, decreased PT (p < 0.0001). Finally, PT for a low-frequency stimulus (ie, 60 Hz) was unaffected by mixing with a sub-PT high-frequency stimulus., Conclusions: In contrast to previous work investigating narrower ranges, PW primarily influenced PT, independently of frequency. Paresthesia quality was primarily influenced by pulse frequency. These findings advance our understanding of SCS therapy and may be used to improve future novel neuromodulation paradigms., Competing Interests: Conflict of Interest John Hatheway has received funding from Medtronic, Nalu, Biotronik, and Boston Scientific. Michael Yang has consulted for and participated in research sponsored by Boston Scientific and Nevro, as well as participated in research sponsored by Saluda. Michael Fishman was a former Director for North American Neuromodulation Society and has consulted for Abbott, Neuromodulation, Aurora Pain Care, Biotronik, Bridge Therapeutics, Brixton Biosciences, Institute for Musculoskeletal Education, Medtronic, and Saluda Medical; is the cofounder of Celéri Health and Occam’s Razor and holds stock for Celéri Health, Occam’s Razor, Aurora Spine, and Thermaquil; has conducted research with Abbott, Biotronik, Boston Scientific, Foundation Fusion Solutions (Cornerloc), InterAxon, Medtronic, Nalu Medical, PainQX, Seikagaku, SGX Medical, and Thermaquil; is an employee of the Center for International Pain & Spine, and his spouse is an employee of Global Medical. Michael Verdolin has consulted for Medtronic, Vertiflex, and Boston Scientific. Tory McJunkin has consulted for Nevro and has conducted research with Nevro and Saluda. Steven Rosen has conducted research with Saluda and Boston Scientific and has consulted for Flowonix. Sean Slee and Andrew Kibler are paid employees of BIOTRONIK NRO, Inc, a subsidiary of BIOTRONIK SE & Co. KG. Kasra Amirdelfan has consulted for Medtronic, Boston Scientific, Nevro, Biotronik, and Nalu, and holds minor options for Nalu., (Copyright © 2023. Published by Elsevier Inc.)

Purpose: To assess the safety and effectiveness of intradiscal hydrogel in patients with chronic low back pain (CLBP) due to degenerative disc disease (DDD) refractory to conventional medical management., Materials and Methods: Twenty patients aged 22-69 years with numerical rating scale (NRS) pain of ≥4 were enrolled. All patients with CLBP resulting from DDD confirmed by imaging and discography received injections of hydrogel (Hydrafil Intervertebral Disc Augmentation; ReGelTec, Baltimore, Maryland) at 1 or 2 lumbar levels (29 levels treated) from August to December 2020. The primary safety end point was freedom from serious adverse events (SAEs). The primary performance end point was successful gel delivery into the desired disc. Patients were also assessed on the NRS as well as the Oswestry disability index (ODI)., Results: Nineteen patients were followed up at a mean of 131 days, and 1 patient was lost to follow-up. Preliminary results showed significant reductions in median NRS back pain from 7 (range 4-10) to 1 (range 0-8) (P <.0001) and median ODI scores from 54 (range 22-58) to 2 (range 0-58) (P <.0001) at 6 months of follow-up. There were 5 SAEs, and 4 of the 2 were determined to be associated with treatment., Conclusions: This early feasibility study showed that the hydrogel implant was safe with no persistently symptomatic SAEs, and demonstrated effectiveness with significant reduction in pain and improvement in function when used to treat painful DDD and CLBP., (Copyright © 2023. Published by Elsevier Inc.)

Background: Chronic, intractable, neuropathic pain is readily treatable with spinal cord stimulation (SCS). Technological advancements, including device miniaturization, are advancing the field of neuromodulation., Objectives: We report here the results of an SCS clinical trial to treat chronic, low back and leg pain, with a micro-implantable pulse generator (micro-IPG)., Study Design: This was a single-arm, prospective, multicenter, postmarket, observational study., Setting: Patients were recruited from 15 US-based comprehensive pain centers., Methods: This open-label clinical trial was designed to evaluate the performance of the Nalu™ Neurostimulation System (Nalu Medical, Inc., Carlsbad, CA) in the treatment of low back and leg pain. Patients, who provided informed consent and were successfully screened for study entry, were implanted with temporary trial leads. Patients went on to receive a permanent implant of the leads and micro-IPG if they demonstrated a >= 50% reduction in pain during the temporary trial period. Patient-reported outcomes (PROs), such as pain scores, functional disability, mood, patient impression of change, comfort, therapy use profile, and device ease of use, were captured., Results: At baseline, the average pain Visual Analog Scale (VAS) score was 72.1 ± 17.9 in the leg and 78.0 ± 15.4 in the low back. At 90 days following permanent implant (end of study), pain scores improved by 76% (VAS 18.5 ± 18.8) in the leg and 75% (VAS 19.7 ± 20.8) in the low back. Eighty-six percent  of both leg pain and low back pain patients demonstrated a >= 50% reduction in pain at 90 days following implant. The comfort of the external wearable (Therapy Disc and Adhesive Clip) was rated 1.16 ± 1.53, on average, at 90 days on an 11-point rating scale (0 = very comfortable, 10 = very uncomfortable). All PROs demonstrated statistically significant symptomatic improvement at 90 days following implant of the micro-IPG., Limitations:   Limitations of this study include the lack of long-term results (beyond 90 days) and a relatively small sample size of 35 patients who were part of the analysis; additionally, there was no control arm or randomization as this was a single-arm study, without a comparator, designed to document the efficacy and safety of the device. Therefore, no direct comparisons to other SCS systems were possible., Conclusions: This clinical study demonstrated profound leg and low back pain relief in terms of overall pain reduction, as well as the proportion of therapy responders. The study patients reported the wearable aspects of the system to be very comfortable.

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. Primary end points were mean NRS change from baseline to final in-office visit for each multiphase therapy and between therapies. Secondary end points included mean NRS change from end of commercial trial to final study visit and incidence of device-related adverse events (AEs). Additional measures included patient-reported outcomes collected at home through electronic watches and written diaries. Power usage was compared between multiphase and commercial therapies., Results: A total of 122 participants initiated a commercial trial; 77 were randomized to a multiphase arm, and 65 completed the study. Reductions in mean NRS scores from baseline to final study visit were significant for multiphase therapy A and B (-4.3 and -4.7, respectively; both p < 0.0001). There was no statistically significant difference in mean NRS reduction or percent pain relief between multiphase therapies. In an additional analysis, 63.9% of participants reported greater pain relief with multiphase than with commercial SCS therapy in the at-home setting. On average, multiphase required less power than did commercial devices. One non-serious device-related AE was reported, and no infections occurred during the extended trial., Conclusions: Multiphase SCS effectively reduced pain in participants with chronic low back and/or leg pain during a trial, with no unanticipated device-related AEs reported. Future studies should evaluate long-term effectiveness of multiphase stimulation., Clinical Trial Registration: The Clinicaltrials.gov registration number for the study is NCT03594266., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: Emerging spinal cord stimulation (SCS) remote monitoring and programming technologies provide a unique opportunity to address challenges of in-person visits and improve patient care, although clinical guidance on implementation is needed. The goal of this document is to establish best clinical practices for integration of remote device management into the care of patients with SCS, including remote monitoring and remote programming., Materials and Methods: A panel of experts in SCS met in July 2022, and additional experts contributed to the development of recommendations after the meeting via survey responses and correspondence., Results: Major goals of remote SCS device management were identified, including prompt identification and resolution of SCS-related issues. The panel identified metrics for remote monitoring and classified them into three categories: device-related (eg, stimulation usage); measurable physiologic or disease-related (eg, patient physical activity or pedometry); and patient-reported (eg, sleep quality and pain intensity). Recommendations were made for frequency of reviewing remote monitoring metrics, although providers should tailor follow-up to individual patient needs. Such periodic reviews of remote monitoring metrics would occur separately from automatic monitoring system notifications (if key metrics fall outside an acceptable range). The guidelines were developed in consideration of reimbursement processes, privacy concerns, and the responsibilities of the care team, industry professionals, manufacturers, patients, and caregivers. Both existing and needed clinical evidence were covered, including outcomes of interest for future studies., Conclusions: Given the expansion of SCS device capabilities, this document provides critical guidance on best practices for using remote device management, although medical necessity should drive all remote monitoring decisions, with individualized patient care. The authors also describe the potential of these emerging technologies to improve outcomes for patients with SCS, although more clinical evidence is needed., Competing Interests: Conflict of Interest Peter Staats has received consulting and research grants from Medtronic, Boston Scientific, Nevro, Abbott, Biotronik, Nalu, Saluda, and Vertos, receives royalties from Averitas, and is the founder and CMO of electroCore. Timothy R. Deer is a consultant for Abbott, Saluda, Nalu, and Medtronic, a research investigator for Abbott, Saluda, and Mainstay, has stock options with Saluda and Nalu, and has a patent pending with Abbott for dorsal root ganglion surgical leads. Corey Hunter has consulted for Abbott, Biotronik, Mainstay, Nalu, PainTEQ, Saluda, and Vertos, served as a research investigator for Abbott, Saluda, Biotronik, Mesoblast, Discgenics, Vivex, TissueGene, FusMobile, Averitas, and Mainstay, and has stock options with Mainstay, Nalu, PainTEQ, Vivex and Vertos. Sean Li has consulted for Nevro (research grant), Boston Scientific (research grant), Saluda (research grant), Abbott, Avanos (research grant), Vertos, Nalu (research grant, shareholder), PainTeq (research grant), Averitas Pharma (research grant), SPR Therapeutics (research grant), and Biotronik (research grant), has received a research grant from SGX Medical, and has served on advisory boards for Saluda and Vertos and on a speaker bureau for Scilex Pharma. David Dickerson has received speaking and consulting fees from SPR Therapeutics (research grant), Pfizer, Myovant, Abbott (research grant), Vertos, Nalu, and Biotronik. Erika Petersen has received research support from Mainstay, Medtronic, Nalu, Neuros Medical, Nevro Corp, ReNeuron, SPR, and Saluda, in addition to personal fees from Abbott Neuromodulation, Biotronik, Medtronic Neuromodulation, Nalu, Neuros Medical, Nevro, Presidio Medical, Saluda, and Vertos. She holds stock options from SynerFuse and neuro42. Leonardo Kapural has consulted for Nevro, Abbott, Medtronic, Nalu, Saluda, and Biotronik and participated in research for Nevro, Medtronic, Gimer Medical, Neuros, Saluda, Biotronik, and SPR Therapeutics. Shravani Durbhakula has consulted for Averitas Pharma. She is a shareholder of Patient Premier, Inc. Christopher Gilligan is the editor-in-chief of Pain Practice and has consulted for Mainstay Medical, Saluda, Persica, and Iliad Lifesciences. Konstantin V. Slavin reports institutional grants and consulting income from Medtronic, Abbott, Boston Scientific, Neuros, Integer, Biotronik, and WISE, and minor ownership of Neuramodix, Thermaquil, Vycor Medical and Higgs Boson. Jason Pope serves as a consultant for Abbott, Medtronic, Saluda, Flowonix, SpineThera, Painteq, Vertos, Vertiflex, SPR Therapeutics, Tersera, Aurora, Spark, Ethos, Biotronik, Mainstay, WISE, Boston Scientific, and Thermaquil and has received grant and research support from Abbott, Flowonix, Saluda, Aurora, Painteq, Ethos, Muse, Boston Scientific, SPR Therapeutics, Mainstay, Vertos, AIS, and Thermaquil. Kasra Amirdelfan has consulted for Medtronic, Boston Scientific, Nevro, Biotronik, and Nalu (minor options). Lawrence Poree has consulted for Medtronic, Nalu, and Saluda. Ramana Naidu has served on Speakers Bureau for Abbott, Avanos, Boston Scientific, and Nalu, as a consultant for Abbott, Biotronik, Bioventus, Boston Scientific, Medtronic, Nalu, SPR Therapeutics, and Avanos, on an advisory/medical board for Abbott, Boston Scientific, Nalu, and SPR Therapeutics, and as an investigator for Abbott and Boston Scientific. Robert M. Levy is an unpaid consultant for Saluda, Nalu, and Mainstay Medical., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Aims: To evaluate the long-term efficacy of high-frequency (10 kHz) spinal cord stimulation (SCS) for treating refractory painful diabetic neuropathy (PDN)., Methods: The SENZA-PDN study was a prospective, multicenter, randomized controlled trial that compared conventional medical management (CMM) alone with 10 kHz SCS plus CMM (10 kHz SCS+CMM) in 216 patients with refractory PDN. After 6 months, participants with insufficient pain relief could cross over to the other treatment. In total, 142 patients with a 10 kHz SCS system were followed for 24 months, including 84 initial 10 kHz SCS+CMM recipients and 58 crossovers from CMM alone. Assessments included pain intensity, health-related quality of life (HRQoL), sleep, and neurological function. Investigators assessed neurological function via sensory, reflex, and motor tests. They identified a clinically meaningful improvement relative to the baseline assessment if there was a significant persistent improvement in neurological function that impacted the participant's well-being and was attributable to a neurological finding., Results: At 24 months, 10 kHz SCS reduced pain by a mean of 79.9% compared to baseline, with 90.1% of participants experiencing ≥50% pain relief. Participants had significantly improved HRQoL and sleep, and 65.7% demonstrated clinically meaningful neurological improvement. Five (3.2%) SCS systems were explanted due to infection., Conclusions: Over 24 months, 10 kHz SCS provided durable pain relief and significant improvements in HRQoL and sleep. Furthermore, the majority of participants demonstrated neurological improvement. These long-term data support 10 kHz SCS as a safe and highly effective therapy for PDN., Trial Registration: ClincalTrials.gov Identifier, NCT03228420., Competing Interests: Declaration of competing interest Author Erika A. Petersen has received consulting fees from Abbott Laboratories, Biotronik, Boston Scientific, Medtronic Neuromodulation, Nalu Medical, Neuros Medical, Nevro Corp, Presidio Medical, Saluda, and Vertos Medical, research support from Mainstay, Medtronic Neuromodulation, Nalu Medical, Neuros Medical, Nevro Corp, ReNeuron, Saluda, and SPR, and stock options from neuro42 and SynerFuse. Author Thomas G. Stauss has received research support from Nevro Corp. Author James A. Scowcroft has received research support from Boston Scientific, Nevro Corp, Saluda Medical, and Vertiflex. Author Michael J. Jaasma is an employee of Nevro Corp. Author Elizabeth S. Brooks was an employee of Nevro Corp during her contributions to the work associated with this manuscript. Author Deborah R. Edgar received consulting fees from Nevro in her capacity as an independent medical writer. Author Judith L. White has received consulting fees from California Institute for Biomedical Research and Eli Lilly and research support from Nevro Corp. Author Shawn M. Sills has received research support from Nevro Corp. Author Kasra Amirdelfan has received consulting fees from Biotronik, Medtronic, Nalu Medical, Nevro Corp, and Saluda Medical, as well as research support from Biotronik, IPM Medical Group, Nevro Corp, Saluda Medical, SPR Therapeutics, and Vivex Biologics. Author Maged N. Guirguis has received consulting fees from Abbott Laboratories, Avanos Medical, Avertis Pharmacy, Boston Scientific, Nevro Corp, and Saluda Medical, as well as research support from Abbott Laboratories, Avanos Medical, Boston Scientific, Nalu Medical, Neuros Medical, Nevro Corp, and Saluda Medical. Author Jijun Xu has received research support from the Cleveland Clinic Velosano Program, the National Institutes of Health, the Steve and Melody Golding Foundation, and Nevro Corp. Author Cong Yu has received research support from Nevro Corp. Author Ali Nairizi has received consulting fees from Aurora Spine, Flowonix, and Nevro Corp as well as research support from Nevro Corp. Author Denis G. Patterson has received consulting fees from Abbott Laboratories, AIS Healthcare, Allergan, Amgen, Aurora Spine, CornerLoc, Flowonix, Lundbeck, Pajunk Medical, Saluda Medical, Spark Biomedical, and Vertos Medical, research support from Abbott Laboratories, Aurora Spine, Flowonix, Nevro Corp, and Saluda Medical, speakers’ bureau or honoraria from Abbott Laboratories, Allergan, Amgen, CornerLoc, Lundbeck, Saluda Medical, and Vertos Medical, and stock options from CornerLoc. Author Michael J. Creamer has received research support from Nevro Corp. Author Vincent Galan has received research support from Biotronik, Medtronic, Nevro Corp, PainTEQ, SPR Therapeutics, and St. Jude. Author Richard H. Bundschu has received research support from Nevro Corp. Author Neel D. Mehta has received consulting fees from Averitas, Nevro Corp, and Salix Pharmaceuticals, as well as research support from Boston Scientific and Nevro Corp. Author Dawood Sayed has received consulting fees from Abbott Laboratories, Boston Scientific, Flowonix, Medtronic, Nevro Corp, Vertiflex, and Vertos Medical, as well as research support from Abbott Laboratories, Biotronic, Nevro Corp, Vertiflex, and Vertos Medical. Author Shivanand P. Lad has received consulting fees from Nevro Corp and research support from Nevro Corp. Author David J. DiBenedetto has received research support from Nevro Corp, as well as funding for serving as principal investigator of a study supported by SPR Therapeutics paid to his institution. Author Khalid A. Sethi has received research support from Nevro Corp. Author Johnathan H. Goree has received consulting fees from Abbott Laboratories and Stratus Medical. Author Paul W. Wu has received research support from Nevro Corp. Author Charles E. Argoff has received consulting fees from AbbVie, Amgen, Biohaven, Clexio Biosciences, Collegium, Eli Lilly, Elsevier, Flowonix, Gene Pharma, Lundbeck, Nevro Corp, Novartis, Pfizer, SK Life Science, Teva Pharmaceutical, and Vertex as well as research support from AbbVie, Allergan, Amgen, Daiichi Sankyo, Eli Lilly, Novartis, Teva Pharmaceutical, and Vertex Pharmaceuticals. Author Christian E. Nasr has received consulting fees from Exelixis, Neurogastrx, and Nevro Corp as well as research support from Nevro Corp. Author Rod S. Taylor has received consulting fees from Nevro Corp, Medtronic, and Saluda Medical. Author David L. Caraway is an employee of Nevro Corp. Author Nagy A. Mekhail has received consulting fees from Nevro Corp, Relievant Medsystems, Saluda Medical, Sollis Therapeutics, and Vertos Medical, as well as research support from Avanos Medical, Mesoblast, Neuros Medical, and Nevro Corp., (Copyright © 2023. Published by Elsevier B.V.)

Background: Posterior and lateral techniques have been described as approaches to sacroiliac joint arthrodesis. The purpose of this study was to compare the stabilizing effects of a novel posterior stabilization implant and technique to a previously published lateral approach in a cadaveric multidirectional bending model. We hypothesized that both approaches would have an equivalent stabilizing effect in flexion-extension and that the posterior approach would exhibit better performance in lateral bending and axial rotation. We further hypothesized that unilateral and bilateral posterior fixation would stabilize both the primary and secondary joints., Methods: Ranges of motion (RoMs) of six cadaveric sacroiliac joints were evaluated by an optical tracking system, in a multidirectional flexibility pure moment model, between ± 7.5 N-m applied moment in flexion-extension, lateral bending, and axial rotation under intact, unilateral fixation, and bilateral fixation conditions., Results: Intact RoMs were equivalent between both samples. For the posterior intra-articular technique, unilateral fixation reduced the RoMs of both primary and secondary joints in all loading planes (flexion-extension RoM by 45%, lateral bending RoM by 47%, and axial RoM by 33%), and bilateral fixation maintained this stabilizing effect in both joints (flexion-extension at 48%, lateral bending at 53%, and axial rotation at 42%). For the lateral trans-articular technique, only bilateral fixation reduced mean RoM of both primary and secondary sacroiliac joints, and only under flexion-extension loads (60%)., Conclusion: During flexion-extension, the posterior approach is equivalent to the lateral approach, while producing superior stabilization during lateral bend and axial rotation., (© 2023. The Author(s).)

Chronic pain impacts one in five Americans and is difficult to manage, costing ~USD 600 billion annually. The subjective experience of pain is a complex processing of central nervous system input. Recent advances in magnetic resonance imaging revealed the prefrontal cortex as vital to the perception of pain and that changes in the cerebral hemodynamics can be used to detect painful sensations. Current pain monitoring is dependent on the subjective rating provided by patients and is limited to a single time point. We have developed a biomarker for the objective, real-time and continuous chronic pain assessment using proprietary algorithms termed ROPA and cerebral optical spectrometry. Using a forehead sensor, the cerebral optical spectrometry data were collected in two clinical sites from 41 patients (19 and 22, respectively, from sites 1 and 2), who elected to receive an epidural steroid injection for the treatment of chronic pain. Patients rated their pain on a numeric rating scale, ranging from 0-10, which were used to validate the ROPA objective pain scoring. Multiple time points, including pre- and post-procedure were recorded. The steroid injection was performed per standard medical practice. There was a significant correlation between the patient's reported numeric rating scale and ROPA, for both clinical sites (Overall ~0.81). Holding the subjective pain ratings on a numeric rating scale as ground truth, we determined that the area under the receiver operator curves for both sites revealed at least good (AUC: 64%) to excellent (AUC > 98%) distinctions between clinically meaningful pain severity differentiations (no/mild/moderate/severe). The objective measure of chronic pain (ROPA) determined using cerebral optical spectrometry significantly correlated with the subjective pain scores reported by the subjects. This technology may provide a useful method of detection for the objective and continuous monitoring and treatment of patients with chronic pain, particularly in clinical circumstances where direct assessment is not available, or to complement the patient-reported pain scores.

Objective: To evaluate high-frequency (10-kHz) spinal cord stimulation (SCS) treatment in refractory painful diabetic neuropathy., Patients and Methods: A prospective, multicenter randomized controlled trial was conducted between Aug 28, 2017 and March 16, 2021, comparing conventional medical management (CMM) with 10-kHz SCS+CMM. The participants had hemoglobin A1c level of less than or equal to 10% and pain greater than or equal to 5 of 10 cm on visual analog scale, with painful diabetic neuropathy symptoms 12 months or more refractory to gabapentinoids and at least 1 other analgesic class. Assessments included measures of pain, neurologic function, and health-related quality of life (HRQoL) over 12 months with optional crossover at 6 months., Results: The participants were randomized 1:1 to CMM (n=103) or 10-kHz SCS+CMM (n=113). At 6 months, 77 of 95 (81%) CMM group participants opted for crossover, whereas none of the 10-kHz SCS group participants did so. At 12 months, the mean pain relief from baseline among participants implanted with 10-kHz SCS was 74.3% (95% CI, 70.1-78.5), and 121 of 142 (85%) participants were treatment responders (≥50% pain relief). Treatment with 10-kHz SCS improved HRQoL, including a mean improvement in the EuroQol 5-dimensional questionnaire index score of 0.136 (95% CI, 0.104-0.169). The participants also reported significantly less pain interference with sleep, mood, and daily activities. At 12 months, 131 of 142 (92%) participants were "satisfied" or "very satisfied" with the 10-kHz SCS treatment., Conclusion: The 10-kHz SCS treatment resulted in substantial pain relief and improvement in overall HRQoL 2.5- to 4.5-fold higher than the minimal clinically important difference. The outcomes were durable over 12 months and support 10-kHz SCS treatment in patients with refractory painful diabetic neuropathy., Trial Registration: clincaltrials.gov Identifier: NCT03228420., (© 2022 The Authors.)

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., Objective: To determine whether ECAP-controlled, closed-loop SCS is associated with better outcomes compared with fixed-output, open-loop SCS at 24 months following implant., Design, Setting, and Participants: The Evoke study was a double-blind, randomized, controlled, parallel arm clinical trial with 36 months of follow-up. Participants were enrolled from February 2017 to 2018, and the study was conducted at 13 US investigation sites. SCS candidates with chronic, intractable back and leg pain refractory to conservative therapy, who consented, were screened. Key eligibility criteria included overall, back, and leg pain visual analog scale score of 60 mm or more; Oswestry Disability Index score of 41 to 80; stable pain medications; and no previous SCS. Analysis took place from October 2020 to April 2021., Interventions: ECAP-controlled, closed-loop SCS was compared with fixed-output, open-loop SCS., Main Outcomes and Measures: Reported here are the 24-month outcomes of the trial, which include all randomized patients in the primary and safety analyses. The primary outcome was a reduction of 50% or more in overall back and leg pain assessed at 3 and 12 months (previously published)., Results: Of 134 randomized patients, 65 (48.5%) were female and the mean (SD) age was 55.2 (10.6) years. At 24 months, significantly more closed-loop than open-loop patients were responders (≥50% reduction) in overall pain (53 of 67 [79.1%] in the closed-loop group; 36 of 67 [53.7%] in the open-loop group; difference, 25.4% [95% CI, 10.0%-40.8%]; P = .001). There was no difference in safety profiles between groups (difference in rate of study-related adverse events: 6.0 [95% CI, -7.8 to 19.7]). Improvements were also observed in health-related quality of life, physical and emotional functioning, and sleep, in parallel with opioid reduction or elimination. Objective neurophysiological measurements substantiated the clinical outcomes and provided evidence of activation of inhibitory pain mechanisms., Conclusions and Relevance: ECAP-controlled, closed-loop SCS, which elicited a more consistent neural response, was associated with sustained superior pain relief at 24 months, consistent with the 3- and 12-month outcomes.

Introduction: The International Neuromodulation Society convened a multispecialty group of physicians based on expertise with international representation to establish evidence-based guidance on the use of neurostimulation in the cervical region to improve outcomes. This Neurostimulation Appropriateness Consensus Committee (NACC) project intends to provide evidence-based guidance for an often-overlooked area of neurostimulation practice., Materials and Methods: Authors were chosen based upon 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 NACC last published guidelines) to the present. Identified studies were graded using the US Preventive Services Task Force criteria for evidence and certainty of net benefit. Recommendations are based on the strength of evidence or consensus when evidence was scant., Results: The NACC 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 NACC recommends best practices regarding the use of cervical neuromodulation to improve safety and efficacy. The evidence- and consensus-based recommendations should be utilized as a guide to assist decision making when clinically appropriate., (Copyright © 2021 International Neuromodulation Society. Published by Elsevier Inc. All rights reserved.)

Background: The objective of this prospective, multicenter study is to characterize responses to percutaneous medial branch peripheral nerve stimulation (PNS) to determine if results from earlier, smaller single-center studies and reports were generalizable when performed at a larger number and wider variety of centers in patients recalcitrant to nonsurgical treatments., Materials & Methods: Participants with chronic axial low back pain (LBP) were implanted with percutaneous PNS leads targeting the lumbar medial branch nerves for up to 60 days, after which the leads were removed. Participants were followed long-term for 12 months after the 2-month PNS treatment. Data collection is complete for visits through end of treatment with PNS (primary end point) and 6 months after lead removal (8 months after start of treatment), with some participant follow-up visits thereafter in progress., Results: Clinically and statistically significant reductions in pain intensity, disability, and pain interference were reported by a majority of participants. Seventy-three percent of participants were successes for the primary end point, reporting clinically significant (≥30%) reductions in back pain intensity after the 2-month percutaneous PNS treatment (n = 54/74). Whereas prospective follow-up is ongoing, among those who had already completed the long-term follow-up visits (n = 51), reductions in pain intensity, disability, and pain interference were sustained in a majority of participants through 14 months after the start of treatment., Conclusion: Given the minimally invasive, nondestructive nature of percutaneous PNS and the significant benefits experienced by participants who were recalcitrant to nonsurgical treatments, percutaneous PNS may provide a promising first-line neurostimulation treatment option for patients with chronic axial back pain., (© 2021 The Authors. Pain Practice published by Wiley Periodicals LLC on behalf of World Institute of Pain.)