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Jason E Pope,1 Timothy Ray Deer,2 Dawood Sayed,3 Ajay B Antony,4 Harjot Singh Bhandal,1 Aaron K Calodney,5 Krishnan Chakravarthy,6 Shrif Costandi,7 Jack Diep,8 Shravani Durbhakula,9 Michael A Fishman,10 Christopher Gilligan,11 Johnathan Heck Goree,12 Maged Guirguis,13 Jonathan Michael Hagedorn,14 Corey William Hunter,15,16 Jan Willem Kallewaard,17,18 Leonardo Kapural,19– 21 Christopher M Lam,3 Sean Li,22 Brian Mayrsohn,23,24 Harold Nijhuis,25 Serge Nikolic,26 Erika A Petersen,27 Lawrence Raymond Poree,28 Shawn K Puri,29 David E Reece,30 Steven Mark Rosen,31 Marc A Russo,32 Jay M Shah,33 Peter Sean Staats,34 Paul Verrills,35 Chau M Vu,1 Robert M Levy,36 Nagy Mekhail37 1Evolve Restorative Center, Santa Rosa, CA, USA; 2Pain Services, The Spine & Nerve Center of the Virginias, Charleston, WV, USA; 3Department of Anesthesiology and Pain Medicine, The University of Kansas Medical Center, Kansas City, KS, USA; 4The Orthopaedic Institute, Gainesville, FL, USA; 5Clinical Research, Precision Spine Care, Tyler, TX, USA; 6Anesthesiology and Pain Medicine, Solaris Research Institute, Wilmington, DE, USA; 7Pain Medicine, Cleveland Clinic, Cleveland, OH, USA; 8Nevada Pain Management, Las Vegas, NV, USA; 9Department of Anesthesiology, Vanderbilt University School of Medicine, Nashville, TN, USA; 10Michael Fishman MD PLLC, Lebanon, PA, USA; 11Robert Wood Johnson University Hospital, New Brunswick, NJ, USA; 12Department of Anesthesiology, University of Arkansas for Medical Sciences, Little Rock, AR, USA; 13Interventional Pain Management Department, Ochsner Health System, New Orleans, LA, USA; 14Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN, USA; 15Ainsworth Institute of Pain Management, New York City, NY, USA; 16Physical Medicine & Rehabilitation, Icahn School of Medicine at Mount Sinai Hospital, New York City, NY, USA; 17Amsterdam University Medical Centre, Amsterdam, The Netherlands; 18Rijnstate Hospital, Arnhem, The Netherlands; 19Carolinas Pain Institute, Winston Salem, NC, USA; 20Centers for Clinical Research, Winston Salem, NC, USA; 21Chronic Pain Research Institute, Winston Salem, NC, USA; 22National Spine and Pain Centers, Shrewsbury, NJ, USA; 23Interventional Pain Management, Maywell Health, Plainview, NY, USA; 24Interventional Pain Management, Maywell Health, New York City, NY, USA; 25Anesthesiology, St Antonius Hospital, Nieuwegein, Utrecht, The Netherlands; 26Pain Medicine and Neuromodulation, St Bartholomew’s Hospital, Barts Health NHS Trust, London, UK; 27Department of Neurosurgery, University of Arkansas for Medical Sciences, Little Rock, AR, USA; 28Anesthesia- Division of Pain Medicine, University of California, San Francisco, CA, USA; 29Integrated Pain Associates, Killeen, TX, USA; 30Absolute Pain Management, Rockville, MD, USA; 31Delaware Valley Pain and Spine Institute, Trevose, PA, USA; 32School of Biomedical Sciences, University of Newcastle, Newcastle, NSW, Australia; 33Samwell Institute of Pain Management, Colonia, Livingston, and Englewood, NJ, USA; 34National Spine and Pain Centers, Atlantic Beach, FL, USA; 35Metropain, Melbourne, VIC, Australia; 36Neuromodulation: Technology at the Neural Interface, International Neuromodulation Society, Boca Raton, FL, USA; 37Evidence-Based Pain Management Research, Cleveland Clinic, Cleveland, OH, USACorrespondence: Timothy Ray Deer, The Spine and Nerve Center of the Virginias, 400 Court Street, Charleston, WV, 25304, USA, Tel +1 304 347 6141, Email doctdeer@aol.comIntroduction: Neuromodulation has been a staple of treatment for moderate-to-severe chronic refractory pain since the introduction of the first spinal cord stimulator by Norman Shealy in 1967. Appreciating the dynamic nature of electrical modulation of the nervous system from the epidural space, the goal has been consistent, reliable, and therapeutic neural activation of the spinal cord. This has proven to be extremely difficult. Recently, the Food and Drug Administration (FDA) released a guidance on physiologic closed loop controlled (PCLC) devices, highlighting the potential for these therapies to deliver accurate, consistent, real-time therapy, enhancing medical care and reducing variability. Because of the growing neuromodulation market focus on PCLC strategies, the American Society of Pain and Neuroscience (ASPN) sought to develop guidance on safety and efficacy, along with a taxonomy surrounding PCLC systems (PCLCSs) and to develop an evidence-based best practice review.Methods: A librarian-assisted literature search was performed to identify manuscripts relevant to the topic of PCLC stimulation for management of chronic pain. Initial literature search was performed utilizing MEDLINE, EMBASE, Cochrane database, BioMed Central, and Web of Science. Included manuscripts encompassed meta-analyses, systematic reviews, randomized controlled trials (RCTs), prospective or retrospective studies with follow-up to 12 months, limited to the English language. MESH terms utilized included “closed-loop”, “physiologic closed loop controlled”, “spinal cord stimulation”, “closed loop feedback”, “feedback controlled”, “neuromodulation”, “pain”, “persistent pain”, “neuropathic pain”, and “chronic pain”. The modified USPSTF evidence and recommendation grading strategy previously utilized was again employed.Results: Four studies were identified for review, 2 prospective, one retrospective, and one randomized controlled study with at least 12-month follow-up.Conclusion: PCLC neuromodulation is an innovation that requires a responsible introduction. As commercial access grows, there is a responsibility that requires consistency with definition, evidence generation, focused on safety and efficacy.Keywords: spinal cord stimulation, closed loop stimulation, physiologic closed loop stimulation, clinical evidence review, neuropathic pain, chronic pain, neuromodulation

Steven M Falowski,1,* Louis J Raso,2 Vipul Mangal,3 Ali Nairizi,4 Denis G Patterson,5 Michael D Danko,6 Rafael Justiz,7 Rainer S Vogel,8 Sebastian Koga,9 Yousseff Josephson,10 Jason E Pope,11,* Oluwatodimu Richard Raji12 1Argires-Marotti Neurosurgical Associates of Lancaster, Lancaster, PA, USA; 2Jupiter Medical Center, Jupiter, FL, USA; 3National Spine and Pain Centers, Oxon Hill, MD, USA; 4Reno Tahoe Pain Associates, Reno, NV, USA; 5Nevada Pain Specialists, Reno, NV, USA; 6Premier Pain Treatment Institute, Loveland, OH, USA; 7Oklahoma Pain Physicians, Oklahoma City, OK, USA; 8Comprehensive and Interventional Pain Management, Henderson, NV, USA; 9Koga Neurosurgery, Covington, LA, USA; 10National Spine and Pain Centers, Voorhees, NJ, USA; 11Evolve Restorative Center, Santa Rosa, CA, USA; 12Medical Device Development, San Francisco, CA, USA*These authors contributed equally to this workCorrespondence: Oluwatodimu Richard Raji, Medical Device Development, 2390 Mission Street, Suite 8, San Francisco, CA, 94110, USA, Tel +15105707741, Email richardraji@mdevdev.comPurpose: Lumbar interlaminar decompression with interspinous fixation is an established safe and effective treatment for spinal stenosis. Early maintenance of improvements in pain intensity and function are critical for durability of symptom relief. The purpose of this study was to investigate the efficacy of minimally invasive treatments for low back pain during the early period after treatment and their utility in setting the course for longer term success.Patients and Methods: This study utilized patient evaluations at 3- and 6-months following treatment and is part of an actively enrolling, institutional review board (IRB) approved, single-arm, multicenter, prospective, open-label 12-month study. Clinical efficacy was assessed primarily using the change from baseline in Oswestry Disability Index (ODI), Visual Analog Scale (VAS) of the back and leg pain during walking and standing, and Zurich Claudication Questionnaire (ZCQ), and secondarily using the Patient Global Impression of Change (PGIC) and Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1. The safety endpoints were the adverse events and reoperations or revisions at the index level(s).Results: At 6-month post-op, 76%, 62%– 64%, and 64% of patients demonstrated clinical meaningful, and statistically significant improvement in their pain as defined by ZCQ, VAS (back and leg), and ODI, respectively. In addition, 78% of patients noted improvement in PGIC. Two procedure-related adverse events were noted which fully resolved without surgical intervention.Conclusion: This 6-month interim analysis at 42% enrollment of patients was conducted to determine prolonged safety and efficacy of the interspinous fusion device. Our analysis showed a sustained improvement in clinical efficacy, and safety endpoints, when compared to the 3-months evaluations, across both interventional pain and neurosurgery specialties.Keywords: interspinous fixation, degenerative disc disease, neurogenic claudication, spinal stenosis

Natalie Strand,1 Ryan S D’Souza,2 Jay Karri,3 Hemant Kalia,4 Jackie Weisbein,5 Brian J Kassa,6 Nasir Hussain,7 Ahish Chitneni,8 Ryan R Budwany,9 Jonathan Hagedorn,2 Jason E Pope,10 Timothy R Deer,11 Dawood Sayed,12 Alaa Abd-Elsayed13 1Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Phoenix, AZ, USA; 2Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN, USA; 3Physical Medicine and Rehabilitation, Baylor College of Medicine, Houston, TX, USA; 4Department of Physical Medicine and Rehabilitation, Rochester Regional Health, Rochester, NY, USA; 5Napa Valley Orthopaedic, Napa, CA, USA; 6Resident in the Department of Physical Medicine and Rehabilitation, Wayne State University School of Medicine at the Rehabilitation Institute of Michigan, Detroit, MI, USA; 7Department of Anesthesiology, The Ohio State University Wexner Medical Center, Columbus, OH, USA; 8Department of Physical Medicine & Rehabilitation, New York-Presbyterian, New York, NY, USA; 9Resident in the Department of Anesthesiology, West Virginia University, Charleston, WV, USA; 10Interventional Pain Management, Evolve Restorative Center, Santa Rosa, CA, USA; 11Department of Anesthesiology, West Virginia University School of Medicine, Morgantown, WV, USA; 12Department of Anesthesiology, The University of Kansas Medical Center, Kansas City, KS, USA; 13Department of Anesthesiology, University of Wisconsin School of Medicine and Public Health, Madison, WI, USACorrespondence: Natalie Strand, Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, 5777 E Mayo Blvd, Phoenix, AZ, 85054, USA, Email Strand.Natalie@mayo.eduAbstract: Cannabinoids have recently gained a renewed interest due to their potential applicability to various medical conditions, specifically the management of chronic pain conditions. Unlike many other medications, medical cannabis is not associated with serious adverse events, and no overdose deaths have been reported. However, both safety and efficacy data for medical cannabis treatment of chronic, nonmalignant pain conditions are lacking. Therefore, representatives from the American Society of Pain and Neuroscience summarize the evidence, according to level and grade, for medical cannabis treatment of several different pain conditions. Treatment of cancer-related pain has prospective evidentiary support for the use of medical cannabis. Although 3 large and well-designed randomized controlled trials investigated cannabis treatment of cancer-related pain, the evidence yielded only a grade D recommendation. Neuropathic pain has been investigated in prospective studies, but a lack of high-quality evidence renders cannabis treatment for this indication a grade C recommendation. Both safety and efficacy data are lacking for use of medical cannabis to treat chronic nonmalignant pain conditions.Keywords: analgesia, chronic pain, marijuana treatment, neuralgia, postoperative pain

Scott G Pritzlaff,1 Johnathan H Goree,2 Jonathan M Hagedorn,3 David W Lee,4 Kenneth B Chapman,5 Sandy Christiansen,6 Andrew Dudas,7 Alexander Escobar,8 Christopher J Gilligan,9 Maged Guirguis,10 Amitabh Gulati,11 Jessica Jameson,12 Christopher J Mallard,13 Melissa Murphy,14 Kiran V Patel,15 Raj G Patel,16 Samir J Sheth,17 Stephanie Vanterpool,18 Vinita Singh,19 Gregory Smith,2 Natalie H Strand,20 Chau M Vu,21 Tolga Suvar,22 Krishnan Chakravarthy,23 Leonardo Kapural,24 Michael S Leong,25 Timothy R Lubenow,22 Alaa Abd-Elsayed,26 Jason E Pope,21 Dawood Sayed,27 Timothy R Deer28 1Department of Anesthesiology and Pain Medicine, University of California, Davis, Sacramento, CA, USA; 2Department of Anesthesiology, University of Arkansas for Medical Sciences, Little Rock, AR, USA; 3Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Mayo Clinic, Rochester, MN, USA; 4Fullerton Orthopedic Surgery Medical Group, Fullerton, CA, USA; 5The Spine & Pain Institute of New York, New York, NY, USA; 6Department of Anesthesiology and Perioperative Medicine, Oregon Health & Science University, Portland, OR, USA; 7Mays & Schnapp Neurospine and Pain, Memphis, TN, USA; 8Department of Anesthesiology, University of Toledo, Toledo, OH, USA; 9Division of Pain Medicine, Brigham and Women’s Hospital Harvard Medical School, Boston, MA, USA; 10Division of Pain Management, Ochsner Health, New Orleans, LA, USA; 11Department of Anesthesiology and Critical Care, Memorial Sloan Kettering Cancer Center, New York, NY, USA; 12Axis Spine Center, Coeur D’Alene, ID, USA; 13Department of Anesthesiology, University of Kentucky, Lexington, KY, USA; 14North Texas Orthopedics and Spine Center, Grapevine, TX, USA; 15Department of Anesthesiology and Pain Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Northwell Health, Hempstead, NY, USA; 16Capitol Pain Institute, Austin, TX, USA; 17Interventional Pain Management, Sutter Health, Roseville, CA, USA; 18Department of Anesthesiology, University of Tennessee, Knoxville, TN, USA; 19Department of Anesthesiology, Emory University, Atlanta, GA, USA; 20Interventional Pain Management, Mayo Clinic, Scottsdale, AZ, USA; 21Evolve Restorative Center, Santa Rosa, CA, USA; 22Department of Anesthesiology and Pain Medicine, Rush University Medical Center, Chicago, IL, USA; 23Coastal Pain and Spinal Diagnostics Medical Group, San Diego, CA, USA; 24Carolinas Pain Institute, Winston-Salem, NC, USA; 25Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University, Stanford, CA, USA; 26Department of Anesthesiology, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA; 27Department of Anesthesiology, Pain and Perioperative Medicine, University of Kansas, Kansas City, KS, USA; 28The Spine and Nerve Center of the Virginias, Charleston, WV, USACorrespondence: Scott G Pritzlaff, University of California, Davis, 4860 Y Street, Suite 3020, Sacramento, CA, 95817, USA, Tel +1 916 734-6824, Fax +1 916 734-6827, Email spritzlaff@ucdavis.eduAbstract: The need to be competent in neuromodulation is and should be a prerequisite prior to completing a fellowship in interventional pain medicine. Unfortunately, many programs lack acceptable candidates for these advanced therapies, and fellows may not receive adequate exposure to neuromodulation procedures. The American Society of Pain and Neuroscience (ASPN) desires to create a consensus of experts to set a minimum standard of competence for neurostimulation procedures, including spinal cord stimulation (SCS), dorsal root ganglion stimulation (DRG-S), and peripheral nerve stimulation (PNS). The executive board of ASPN accepted nominations for colleagues with excellence in the subject matter of neuromodulation and physician education. This diverse group used peer-reviewed literature and, based on grading of evidence and expert opinion, developed critical consensus guides for training that all accredited fellowship programs should adopt. For each consensus point, transparency and recusal were used to eliminate bias, and an author was nominated for evidence grading oversight and bias control. Pain Education and Knowledge (PEAK) Consensus Guidelines for Neuromodulation sets a standard for neuromodulation training in pain fellowship training programs. The consensus panel has determined several recommendations to improve care in the United States for patients undergoing neuromodulation. As neuromodulation training in the United States has evolved dramatically, these therapies have become ubiquitous in pain medicine. Unfortunately, fellowship programs and the Accreditation Council for Graduate Medical Education (ACGME) pain program requirements have not progressed training to match the demands of modern advancements. PEAK sets a new standard for fellowship training and presents thirteen practice areas vital for physician competence in neuromodulation.Keywords: neuromodulation, pain education, spinal cord stimulation, dorsal root ganglion stimulation, peripheral nerve stimulation, fellowship training

Timothy R Deer,1 Jay S Grider,2 Jason E Pope,3 Tim J Lamer,4 Sayed E Wahezi,5 Jonathan M Hagedorn,6 Steven Falowski,7 Reda Tolba,8 Jay M Shah,9 Natalie Strand,10 Alex Escobar,11 Mark Malinowski,12 Anjum Bux,13 Navdeep Jassal,14 Jennifer Hah,15 Jacqueline Weisbein,16 Nestor D Tomycz,17 Jessica Jameson,18 Erika A Petersen,19 Dawood Sayed20 1Centers for Pain Relief, Charleston, WV, USA; 2UK HealthCare Pain Services, Department of Anesthesiology, University of Kentucky College of Medicine, Lexington, KY, USA; 3Evolve Restorative Center, Santa Rosa, CA, USA; 4Division of Pain Medicine, Department of Anesthesiology, Mayo Clinic, Rochester, MN, USA; 5Montefiore Medical Center, SUNY-Buffalo, Buffalo, NY, USA; 6Department of Anesthesiology and Perioperative Medicine, Division of Pain Medicine, Mayo Clinic, Rochester, MN, USA; 7Director Functional Neurosurgery, Neurosurgical Associates of Lancaster, Lancaster, PA, USA; 8Pain Management Department, Anesthesiology Institute, Cleveland Clinic, Abu Dhabi, UAE; 9SamWell Institute for Pain Management, Colonia, NJ, USA; 10Department of Anesthesiology, Division of Pain Medicine, Mayo Clinic, Phoenix, AZ, USA; 11Department of Anesthesiology and Pain Medicine, University of Toledo Medical Center, Toledo, OH, USA; 12OhioHealth, Neurological Physicians, Columbus, OH, USA; 13Bux Pain Management, Lexington, KY, USA; 14Excel Pain and Spine, Lakeland, FL, USA; 15Department of Anesthesiology, Perioperative, and Pain Medicine, Stanford University, Palo Alto, CA, USA; 16Napa Valley Orthopaedic Medical Group, Inc., Napa, CA, USA; 17Department of Neurological Surgery, Allegheny General Hospital, Allegheny Health Network, Pittsburgh, PA, USA; 18Axis Spine Center, Coeur d’Alene, ID, USA; 19Department of Neurosurgery, University of Arkansas for Medical Sciences, Little Rock, AR, USA; 20Pain Medicine, Multidisciplinary Pain Fellowship, The University of Kansas Health System, Kansas City, KS, USACorrespondence: Timothy R Deer, The Spine and Nerve Centers of the Virginias, 400 Court Street, Suite 100, Charleston, WV, 25301, USA, Tel +1 304 347-6141, Email doctdeer@aol.comIntroduction: Lumbar spinal stenosis (LSS) is a common spinal disease of aging with a growing patient population, paralleling population growth. Minimally invasive treatments are evolving, and the use of these techniques needs guidance to provide the optimal patient safety and efficacy outcomes.Methods: The American Society of Pain and Neuroscience (ASPN) identified an educational need for guidance on the prudent use of the innovative minimally invasive surgical therapies for the treatment of symptomatic LSS. The executive board nominated experts spanning anesthesiology, physiatry, orthopedic surgery, and neurosurgery based on expertise, publications, research, diversity and field of practice. Evidence was reviewed, graded using the United States Preventive Services Task Force (USPSTF) criteria for evidence and recommendation strength and grade, and expert opinion was added to make consensus points for best practice.Results: 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 LSS-related pain. Search words were selected based upon the section represented. Identified peer-reviewed literature was critiqued using USPSTF criteria and consensus points are presented.Discussion: The algorithm for patient selection in the management of symptomatic spinal stenosis is evolving. Careful consideration of patient selection and anatomic architecture variance is critical for improved outcomes and patient safety.Conclusion: ASPN created a guidance for best practice for minimally invasive surgical treatment of symptomatic spinal stenosis.Keywords: percutaneous image-guided lumbar decompression, interspinous spacers, intrathecal drug delivery, open decompression, neurostimulation, epidural steroid injections

Jason E Pope,1 Michael A Fishman,2 Joshua A Gunn,3 Bradley M Cotten,3 Melissa M Hill,3 Timothy R Deer4 1Evolve Restorative Center, Santa Rosa, CA, USA; 2Center for Interventional Pain and Spine, Lancaster, PA, USA; 3Ethos Research and Development, LLC, Newport, KY, USA; 4The Spine and Nerve Center of the Virginias, Charleston, WV, USACorrespondence: Jason E PopeEvolve Restorative Center, Santa Rosa, CA, USATel +1844 527-7369Email jepope@evolverestorativecenter.carePurpose: Discovery and validation of pragmatic biomarkers represent significant advancements in the field of pain management. Evaluating relationships between objective biomarkers and patient-reported outcomes (PROs) is an effective way to gain mechanistic insight into the potential role of biochemistry in chronic pain. The aim of this study was to validate the Foundation Pain Index (FPI) by evaluating associations between deranged biochemical function and PROMIS-29 domains in individuals living with chronic pain.Patients and Methods: PROMIS-29 scores and FPI test results were obtained from 298 patients with chronic pain in this retrospective, observational study. Statistical analysis was performed using clinical test data to evaluate relationships between deranged biochemical function and quality of life measures across 8 universal domains.Results: FPI scores significantly associated with multiple PROMIS-29 domains including physical function, impact score, fatigue, pain interference, and depression (P < 0.05). Moreover, specific analytes that comprise the FPI significantly correlated with PROMIS-29 domains, including 5-hydroxyindolacetic acid (pain interference, physical function, and pain impact scores), hydroxymethylglutarate (physical function), homocysteine (pain impact scores), kynurenic acid (pain interference and physical function), and quinolinic acid (physical function) (P < 0.05).Conclusion: Cross-validation of the FPI with PROMIS-29 domains further supports the role of deranged biochemical function in the etiology of chronic pain. Objective identification of atypical biochemical function and subsequent correction holds tremendous promise for the non-opioid management of pain. Continued research efforts will aim to determine the impact of biochemical optimization in pre-surgical periods and post-surgical outcomes in patients with chronic pain.Keywords: biomarker, pain, oxidative stress, neurotransmitter, micronutrient deficiency, kynurenine pathway

Michael A Fishman,1 Ajay B Antony,2 Corey W Hunter,3 Jason E Pope,4 Peter S Staats,5 Rahul Agarwal,6 Allison T Connolly,6 Nirav Dalal,6 Timothy R Deer7 1Center for Interventional Pain and Spine, Exton, PA, USA; 2The Orthopaedic Institute, Gainesville, FL, USA; 3Ainsworth Institute of Pain Management, New York, NY, USA; 4Evolve Restorative Center, Santa Rosa, CA, USA; 5Premier Pain Centers, Shrewsbury, NJ, USA; 6Abbott, Sylmar, CA, USA; 7The Spine and Nerve Center of the Virginias, Charleston, WV, USACorrespondence: Michael A FishmanCenter for Interventional Pain and Spine, 160 North Pointe Blvd Suite 208, Lancaster, PA, 17603, USATel +1 917-543-6588Email mafishman@gmail.comBackground and Aims: Chronic pain affects more adults in the United States than any other condition. Opioid medications are widely used in the treatment of chronic pain, but there remains considerable risk and cost associated with their use. This study aims to characterize the effects of opioid prescribing for chronic pain and similar pain conditions on lost productivity in the United States.Methods: This was a retrospective, longitudinal, observational study of chronic pain patients in 2011– 2014. We identified patients with a diagnosis of musculoskeletal pain receiving index prescription for opioids in administrative claims and studied disability absence in a linked health and productivity management database. Patients were grouped as de novo and continued use opioid users before index, and by opioid dose in the year after index. Days of disability were compared before and after index with bootstrapping. Effect of opioid dose group on disability was evaluated with negative binomial regression. Lost productivity cost was compared before and after index.Results: The cohort contained 16,273 de novo and 6604 continued use patients. On average, de novo patients used 24.8 days of disability after index, an increase of 18.3 more days compared to before (p < 0.001). Continued use patients used 30.7 days after index, 9 more days than before (p < 0.001). There was a dose–response relationship between dose group and days of disability in de novo patients (p < 0.001). The weighted-average cost per person of lost productivity was $4344 higher in the year after index compared to the year before.Conclusion: Opioid prescriptions for pain patients were associated with significant disability use and lost productivity costs. With the evolution of opioid-prescribing practices, CDC recommendations, and the HHS Pain Management Best Practices, there is opportunity to use alternative pain therapies without the risks of opioid-induced side effects to improve work productivity.Keywords: opioids, pain, disability, productivity

Ajax Yang,1 Krishnan V Chakravarthy,2 Jason E Pope,3 Timothy R Deer4 1Department of Anesthesiology, New York-Presbyterian Hospital/Weill Cornell Medicine, New York, NY, USA; 2Department of Anesthesiology and Pain Medicine, University of California San Diego Health Sciences, La Jolla, CA; VA San Diego Healthcare System, San Diego, CA, USA; 3Evolve Restorative Center, Santa Rosa, CA, USA; 4Center for Pain Relief, Charleston, WV, USACorrespondence: Timothy R DeerCenter for Pain Relief, 400 Court Street, Suite 100, Charleston, WV 25301, USATel +1304 347 6120Email tdeermd@centerforpainrelief.comIntroduction: The algorithmic use of neurostimulation to treat chronic pain is routine. However, it is underutilized in managing pain and other symptoms relating to cardiovascular dysfunctions. The goal of this article is to focus on the clinical results from using spinal cord stimulation (SCS) in the realm of cardiovascular medicine.Material and Methods: The current literature was reviewed, summarized and tabulated. This manuscript contains results from systematic reviews, randomized clinical trials and observational study search results on PubMed spanning the last 30 years. The official positioning statement from the International Neuromodulation Society Neuromodulation Appropriateness Consensus Committee (NACC) was also highlighted.Results: Evidence supports that SCS is asafe, reversible, minimally-invasive and efficacious modality to mitigate chronic symptoms of refractory angina pectoris and critical limb ischemia.Discussion: Spinal cord stimulation is effective in providing relief, improve quality of life and functional mobility in patients living with ischemic pain of systemic arterial occlusive disease.Conclusion: Spinal cord stimulation should be considered early in the treatment algorithm among individuals with inoperable ischemic pain.Keywords: angina pectoris, critical limb ischemia, ischemic pain, congestive heart failure, Reynaud’s syndrome, spinal cord stimulation

Objective: To determine the clinical impact of muscle involvement in a large systemic sclerosis (SSc) cohort. Method: Using the Canadian Scleroderma Research Group (CSRG) database, SSc patients with either elevated creatine kinase (CK) or a prior history of myositis/myopathy were identified. Regression and Kaplan-Meier analyses were performed to determine characteristics associated with muscle involvement in SSc and survival outcome. Results: In 1145 patients with SSc, 5.6% had an elevated CK. This subset was more likely to be male (24.5% in elevated CK vs. 12.6% in normal CK, p < 0.013), younger (52 vs. 56 years, p < 0.045), have diffuse cutaneous SSc (dcSSc; 40.4% vs. 37.9%, p < 0.002), tendon friction rubs (30.0% vs. 13.4%, p < 0.001), and forced vital capacity (FVC) < 70% (23.9% vs. 13.1%, p < 0.039), be ribonucleoprotein (RNP) antibody positive (12.0% vs. 5.0%, p < 0.032), topoisomerase1 (topo1)-antibody positive (26.0% vs. 14.4%, p < 0.026), have a higher modified Rodnan skin score (MRSS; 16.14 vs. 9.81, p < 0.001), and a higher Health Assessment Questionnaire (HAQ) score (0.98 vs. 0.79, p < 0.011). Survival was reduced for patients with elevated CK (p < 0.025). Nearly 10% of patients in the CSRG cohort had a prior history of myositis/myopathy. This subset also had findings similar to those with elevated CK and increased mortality (p < 0.003). Conclusions: Muscle involvement in SSc has a poor prognosis impacting survival, especially in men with early dcSSc with topo1 and RNP autoantibodies and interstitial lung disease (ILD). [ABSTRACT FROM AUTHOR]

Objective.To determine the frequency of pericardial and pleural effusions in scleroderma. [ABSTRACT FROM PUBLISHER]

Emergent complete spine magnetic resonance imaging (MRI) demonstrated severe cord compression due to soft tissue compression between C3 and T3 (Figure 1). Given the prominent IgG SB 4 sb SP + sp plasma cells on histology, rheumatology was consulted for IgG SB 4 sb -related disease (IgG SB 4 sb -RD) but it was felt that his presentation was more in keeping with granulomatosis with polyangiitis (GPA). Conversely, ANCA elevation in IgG SB 4 sb -RD appears to be rare; therefore, ANCA elevation in any suspected cases of IgG SB 4 sb -RD should prompt further work-up to ensure that ANCA-associated vasculitis is not missed ([7], [8]). [Extracted from the article]

A letter to the editor is presented regarding the findings of a research conducted on examining whether C-reactive protein add value in active rheumatoid arthritis.

Objectives: To compare effectiveness of tofacitinib versus tumor necrosis factor inhibitors (TNFi), and across tofacitinib lines of therapy, in patients with rheumatoid arthritis (RA), using US CorEvitas RA Registry data., Methods: Analysis included patients with RA initiating tofacitinib or TNFi with a 12-month follow-up visit between November 2012-February 2021. Primary (Clinical Disease Activity Index-defined low disease activity [CDAI-LDA: CDAI ≤ 10]) and secondary (clinical/disease activity/patient-reported) effectiveness outcomes were assessed at month 12. Outcomes were stratified by treatment regimen (overall tofacitinib vs overall TNFi/tofacitinib monotherapy vs tofacitinib combination therapy/TNFi monotherapy vs TNFi combination therapy/tofacitinib monotherapy vs TNFi combination therapy/tofacitinib combination therapy vs TNFi combination therapy), or tofacitinib line of therapy (2nd/3rd/ ≥ 4th line)., Results: 3,481 eligible patients initiated tofacitinib (n = 805) or TNFi (n = 2,676). Improvements in effectiveness at month 12 were generally similar across treatment regimens; 25.1% and 30.1% of overall tofacitinib and TNFi initiators achieved CDAI-LDA, respectively (odds ratio 1.29 [95% confidence interval (CI) 0.94, 1.76]). Odds ratios (95% CIs) for achieving CDAI-LDA at 12 months were 0.70 (0.36, 1.37) for 3rd- versus 2nd-line, and 1.09 (0.63, 1.88) for 3rd- versus ≥ 4th-line tofacitinib initiators. At month 12, mean change from baseline in CDAI was greater among 3rd- versus ≥ 4th-line tofacitinib initiators, and mean Health Assessment Questionnaire and patient-reported pain were greater in 3rd- versus 2nd-line and ≥ 4th- versus 3rd-line tofacitinib initiators., Conclusions: Generally, there were no differences in effectiveness between tofacitinib versus TNFi regimens. Few differences were observed between tofacitinib lines of therapy; sample sizes were small for 2nd/3rd-line initiators., Study Registration: NCT01402661 (ClinicalTrials.gov; July 25, 2011). Key Points • Using data from the US CorEvitas rheumatoid arthritis (RA) Registry, this study compared the effectiveness of tofacitinib versus tumor necrosis factor inhibitors (TNFi) and across tofacitinib lines of therapy. • Effectiveness of tofacitinib was similar to TNFi regimens up to month 12, while differences in some effectiveness outcomes at month 12 were observed with tofacitinib across different lines of therapy. • The findings of this study may inform future treatment decision-making in patients with RA., Competing Interests: Declarations. Ethical standards: This study was performed in accordance with the Declaration of Helsinki and the Guidelines for Good Pharmacoepidemiology Practice. All participating investigators were required to obtain full institutional review board (IRB) board approval for conducting non-interventional research involving human patients with a limited dataset. Sponsor approval and continuing review were obtained from the New England Independent Review Board (no. 120160610). For academic investigative sites that did not receive authorization to use the central IRB, full board approval was obtained from the respective governing IRBs, and documentation of approval was submitted to CorEvitas, LLC prior to the initiation of any study procedures. All patients in the registry were required to provide written informed consent and authorization prior to participating in the study. Competing interests: LRH has acted as a consultant for AbbVie, Bristol Myers Squibb, Pfizer Inc, and Roche, is a member of a speakers' bureau for Bristol Myers Squibb, and is an employee and shareholder of CorEvitas, LLC. COB has received grant support from Bristol Myers Squibb and has acted as consultant for AbbVie, Eli Lilly, Janssen, Pfizer Inc, and Sanofi. JEP has received grant and/or research support from AbbVie, Fresenius Kabi, Mallinckrodt, Pfizer Inc, and Seattle Genetics, has acted as consultant for AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Eli Lilly, EMERALD, Fresenius Kabi, GSK, Janssen, Mallinckrodt, Mitsubishi Tanabe, Novartis, Organon, Pfizer Inc, Sandoz, Samsung, and Viatris, and has been a speaker/advisory board member for AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Fresenius Kabi, GSK, Janssen, Novartis, Organon, Pfizer Inc, Sandoz, UCB, and Viatris, JOB, PCM, and MY are employees of CorEvitas, LLC. CR-T was an employee of CorEvitas, LLC at the time of the analysis, and is currently affiliated with Harvard School of Public Health. LLS and KRM were employees and shareholders of Pfizer Inc at the time of the analysis. AS is an employee and shareholder of Pfizer Inc., (© 2024. The Author(s).)

Introduction: Many interventional strategies are commonly used to treat chronic low back pain (CLBP), though few are specifically intended to target the distinct underlying pathomechanisms causing low back pain. Restorative neurostimulation has been suggested as a specific treatment for mechanical CLBP resulting from multifidus dysfunction. In this randomized controlled trial, we report outcomes from a cohort of patients with CLBP associated with multifidus dysfunction treated with restorative neurostimulation compared to those randomized to a control group receiving optimal medical management (OMM) over 1 year., Methods: RESTORE is a multicenter, open-label randomized controlled trial. Candidates were assessed for CLBP associated with multifidus dysfunction, with no indication for or history of lumbar spine surgery. Participants were randomized to either restorative neurostimulation with the ReActiv8 system or OMM. The primary endpoint was a comparison of the mean change in the Oswestry Disability Index (ODI) between the treatment and control arms at 1 year, and secondary endpoints included pain (numeric rating scale [NRS]) and health-related quality of life (EuroQol Five-Dimension [EQ-5D-5L])., Results: A total of 203 patients, average age 47 years, and with an average 11-year history of low back pain, were included in the analysis. The primary endpoint was a statistically significant demonstration of a clinically relevant mean improvement in the Oswestry Disability Index (ODI) between restorative neurostimulation and OMM arms: ODI (-19.7 ± 1.4 vs. -2.9 ± 1.4; p < 0.001). Additionally, improvements in both the numeric rating scale (NRS) (-3.6 ± 0.2 vs. -0.6 ± 0.2; p < 0.001) and EuroQol Five-Dimension (EQ-5D-5L) (0.155 ± 0.012 vs. 0.008 ± 0.012; p < 0.001) were statistically and clinically significant in the restorative neurostimulation arm compared to the OMM arm., Conclusion: The RESTORE trial demonstrates that restorative neurostimulation is a safe, reversible, clinically effective, and highly durable option for patients suffering with nonoperative CLBP associated with multifidus dysfunction. This demonstration of treatment superiority over OMM through 1 year is a significant milestone in addressing a major health burden and unmet clinical need., Trial Registration: ClinicalTrials.gov Identifier: NCT04803214., Competing Interests: Declarations. Conflict of Interest: Mainstay Medical (“Mainstay”) funded this trial and compensated all investigators and committee members either directly (consultant fees) or indirectly (payments to institution). Travel expenses related to investigator meetings and training were reimbursed only with prior authorization. Dr. Schwab was the principal investigator for the RESTORE Trial and reports consultant fees and royalties/licenses from Zimmer Biomet, Stryker, and Medtronic, consultant fees from Mainstay Medical and Medicrea, is an executive board member with International Spine Study Group, is a shareholder and has other interests with SeaSpine and VFT Solutions. Dr. K. Patel reports consultant fees from Abbott, Boston Scientific, Biotronik, Mainstay Medical, Vertos, Saluda, SPR Therapeutics, and fiduciary roles as Vice President for the North American Neuromodulation Society and Women Innovators in Pain Medicine, and Director-at-Large for the International Neuromodulation Society. Dr. Langhorst reports consultant fees, honoraria, and meeting support from Mainstay, consultant fees from Vivex, is an advisory/data safety monitoring board member for Vivex, and is a shareholder/holds stock/stock options in Boston Scientific and ATEC Spine. Dr. Heros reports grants, meeting support, and consultant fees from Saluda Medical, grants from Abbott and Ethos Laboratories, meeting support and consultant fees from Mainstay Medical, and consultant fees from Boston Scientific. Dr. Costandi reports grants from Vertos, Medtronic, Vivex, and Saluda. Dr. Moore reports honoraria from Mainstay Medical. Dr. Gilmore reports consultant fees from Mainstay, SPR Therapeutics, Nevro, Nalu, Biotronik, and Saluda, and other interests with SPR Therapeutics. Dr. Chakravarthy reports consultant fees and shareholder/stock options/stock from Mainstay. Dr. Tate reports consultant fees from Nevro, Saluda, Curonix, Vivex, Abbott, Medtronic, and Vertos, honoraria from the Virginia Pain Society and Georgia Society of Interventional Pain Practitioners, board memberships in Women Innovators in Pain Medicine and American Society for Pain and Neuroscience, and secretary of Georgia Society of Interventional Pain Practitioners. Dr. Sanders reports consultant fees and educational event support from Mainstay Medical and Vertos. Dr. Goree reports consultant fees from Saluda, Abbott, and Stratus Medical. Dr. V. Patel reports consultant fees from Mainstay, grants from Orthofix, Pfizer, Premia Spine, Medicrea, Globus, 3-Spine, and Spinal Kinetics, contracts and grants from Aesculap and Medtronic, contracts from Zimmer Biomet Spine, Inc., Johnson & Johnson Medical Device Business Services, NCS America, Simplify Medical, SI Bone, Orthobond Corp., Cerapedics, consultant fees from Spine Welding, SI Bone, expert testimony for Ogborn Mihm, LLP Expert Witness Deposition, and educational event support from Ecential Robotics and Johnson & Johnson Medical. Dr. Lehmen reports consultant fees, honoraria, and meeting support from Mainstay and Globus Medical-NuVasive. Dr. Desai reports royalties/licenses from Nevro, consultant fees from Medtronic, Nalu, and SPR Therapeutics, data safety monitoring/advisory board membership with FUSMobile, shareholder/stock/stock options in HypreVention, SPR Therapeutics, SynerFuse, and Virdio Health. Dr. Pope reports consulting fees, honoraria, research grants, educational support, and shareholder/stock options/stock from Abbott and Saluda, research grants, honoraria, royalties/license, consulting fees and shareholder/stock options/stock from Aurora, research grant from AIS, research grants, consulting fees, and honoraria from Boston Scientific, Flowonix, Ethos, Mainstay Medical, Muse, grants, consulting fees, honoraria, and shareholder/stock options/stock from Painteq, SPR Therapeutics, Theraquil, Vertos, consulting fees and honoraria from Medtronic, Tersera, Vertiflex, and WISE, consulting fees, honoraria, and shareholder/stock options/stock from Spark and SpineThera, shareholder/stock options/stock from Anesthetic Gas Reclamation, Axonics, Celeri Health, Pacific Research Institute, and Stimgenics, royalties/licenses and shareholder/stock options/stock from Neural Integrative Solutions, royalties/licenses from Elsevier and Springer, a patent for Neuronmonitoring, and fiduciary roles as Chairman for Pacific Spine and Pain Society and immediate past president of the American Society for Pain and Neuroscience. Dr. Giuffrida reports consultant fees, medical writing support and a medical advisory board membership from Mainstay, and executive board membership for the American Society of Pain and Neuroscience. Dr. Hayek reports payment for expert witness defense testimony, data safety/monitoring board membership on three non-industry funded studies, and was 2022–2023 past president of North American Neuromodulation Society. Dr. Virk reports research/educational event support from Mainstay, and consultant fees and research support from LifeSpine. Dr. Paicius reports consulting fees from Abbott and Biotronik; Dr. Mekhail functioned as independent medical monitor of the RESTORE trial has a consultancy agreement with Mainstay Medical. Dr. Levy reports unpaid consultancies with Abbott, Biotronik, Nalu, and Saluda, and stock options with Nalu and Saluda. Dr. Gilligan reports consultant fees from Mainstay Medical, Saluda, Persica, Iliad Lifesciences, and Biotronik, expert witness testimony payment, and fiduciary roles as Editor in Chief of Pain Practice, finance committee member for North American Neuromodulation Society, and on the board of directors for International Neuromodulation Society. Drs. Gentile, Bundy, Manion, and Klemme report consultant fees from Mainstay Medical. Drs. Meyer, Vaid, and Szentirmai have no other disclosures. Ethical Approval: The RESTORE trial followed the principles of the Declaration of Helsinki of 1964 and its later amendments and Good Clinical Practice (GCP). The WCG IRB acted as the Central IRB (RN#20,211,219) for most sites while other sites had local IRB approval prior to enrollment of patients. All patients provided written informed consent to participate in the trial., (© 2025. The Author(s).)

Purpose of Review: There have been advances in the diagnosis and treatment of giant cell arteritis (GCA) and polymyalgia rheumatica (PMR)., Recent Findings: Themes in PMR and GCA include classification criteria, ultrasound imaging of temporal and axillary arteries replacing biopsies for diagnosis of GCA, faster diagnosis and treatment with rapid access clinics for suspected GCA, and expanding treatment options with the goal of rapid suppression of inflammation and sparing steroids., Summary: Treatment is aimed at suppressing inflammation quickly in both GCA and PMR. Randomized trials have demonstrated success in reducing glucocorticoids when adding advanced therapies such as interleukin 6 (IL6) inhibitors. Other treatments including Janus kinase (JAK) inhibitors (especially a phase 3 trial of upadacitinib at 15 mg daily and secukinumab (an IL17 inhibitor) are being tested. Some uncontrolled GCA protocols are limiting glucocorticoids to initial IV pulse therapy only or rapid tapering of oral glucocorticoids with upfront treatment with tocilizumab. There is uncertainty of who should have an advanced therapy and how long to use it for and what order to consider advanced therapies when treatment fails. In PMR, studies are performed when patients cannot taper glucocorticoids effectively, whereas in GCA, advanced therapies are started with disease onset or with recurrent GCA., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)