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Anthony Giuffrida,1 Christy Saia-Owenby,2 Chris Andriano,3,* Douglas Beall,4,* Ashley Bailey-Classen,5,* Patrick Buchanan,6,* Ryan Budwany,7,* Mehul J Desai,8,* Ashley Comer,9,* Andrew Dudas,10,* Vinicius Tieppo Francio,11,* Warren Grace,12,* Benjamin Gill,13,* Betsy Grunch,14,* Andrew Goldblum,13,* Rosa A Garcia,15,* David W Lee,16,* Chad Lavender,17,* Marco Lawandy,18,* Lyric Mandell,2,* Robin Mata,19,* Morteza Rabii,20,* Kiran Patel,21,* Raj G Patel,22,* Ankur A Patel,23,* Dawood Sayed,24,* Gurtej Singh,25,* Natalie Strand,26,* Jordan Tate,27,* Michael E Schatman,28 Timothy Deer29 1Cantor Spine Center, Paley Orthopedic and Spine Institute, Fort Lauderdale, FL, USA; 2MOXY Company, Covington, LA, USA; 3Georgia Pain Care, Stockbridge, GA, USA; 4Oklahoma Spine Hospital, Oklahoma City, OK, USA; 5Trinity Pain Medicine Associates, Fort Worth, TX, USA; 6Spanish Hills Interventional Pain Specialists, Camarillo, CA, USA; 7Center for Pain Relief, Charleston Area Medical Center, Charleston, WV, USA; 8International Spine, Pain, and Performance Center, Washington, DC, USA; 9The Spine and Nerve Centers of the Virginias, Charleston, WV, USA; 10Maya & Schnapp, Neurospine and Pain, Memphis, TN, USA; 11Anesthesiology and Pain Medicine, University of Kansas, Kansas City, KS, USA; 12Redefine Healthcare, Orthopedic Pain and Spine Center, Edison, NJ, USA; 13Physical Medicine and Rehabilitation, University of Missouri, Columbia, MO, USA; 14Longstreet Clinic, Gainesville, GA, USA; 15Larkin Hospital Health Systems, Miami, FL, USA; 16Interventional Pain and Spine, Fullerton Orthopedics, Yorba Linda, CA, USA; 17Department of Orthopaedics, Marshall University, Huntington, WV, USA; 18Physical Medicine and Rehabilitation, Montefiore Medical Center, New York, NY, USA; 19Department of Physical Medicine and Rehabilitation, University of Miami, Miami, FL, USA; 20Crimson Pain Management, Overland Park, KS, USA; 21Pain Medicine and Anesthesiology, Northwell Health, New York, NY, USA; 22Central Texas Interventional Pain Doctor, Capitol Pain Institute, Austin, TX, USA; 23Department of Neurological Surgery, UT Southwestern Medical Center, Dallas, TX, USA; 24Department of Pain Medicine and Neurology, University of Kansas Health System, Kansas City, KS, USA; 25Department of Pain Medicine, Rehabilitation, and Pain Medicine, the Center for Advance Orthopaedics, Cantonsville, MD, USA; 26Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Phoenix, AZ, USA; 27Department of Pain Medicine and Physical Medicine and Rehabilitation, Southern Pain and Spine, Jasper, GA, USA; 28Department of Anesthesiology, Perioperative Care, and Pain Medicine at NYU Grossman School of Medicine, New York, NY, USA; 29Department of Pain Management, Spine and Nerve Centers of the Virginias, Charleston, WV, USA*These authors contributed equally to this workCorrespondence: Lyric Mandell, MOXY Company, Covington, LA, USA, Email lyric@moxycompany.comPurpose: The American Society of Pain and Neuroscience (ASPN) identified a significant gap in resources and guidelines that aim to educate healthcare providers for best practices when engaging on social media. As part of the broader initiatives on Spine and Nerve practice, the executive board of ASPN has decided it would be beneficial to include comprehensive guidance for healthcare providers when engaging on social media.Methods: A panel of experts was chosen based on expertise, publications, diversity, and their social media presence. Along with expert guidance, the committee conducted an extensive analysis of peer-reviewed literature in communication and medical journals to determine best practices for healthcare practitioners on social media.Results: Social media messages significantly impact patients’ and colleagues’ perceptions and actions regarding medical issues. As such, providers and their teams must be aware of legal and ethical considerations in healthcare while maintaining a consistent, educational, and digestible persona online.Conclusion: The advancement of communication and medical technologies and systems necessitates continued education and resources to adapt to our rapidly changing media and medical landscape.Keywords: digital communication, social networking sites, healthcare providers, best practices, physician communication, social media, medical marketing, spine

Timothy Deer,1 Ankur A Patel,2 Dawood Sayed,3 Ashley Bailey-Classen,4 Ashley Comer,1 Benjamin Gill,5 Kiran Patel,6 Alaa Abd-Elsayed,7 Natalie Strand,8 Jonathan M Hagedorn,9 Zohra Hussaini,3 Nasir Khatri,10 Ryan Budwany,1 Melissa Murphy,11 Dan Nguyen,12 Vwaire Orhurhu,13 Morteza Rabii,14 Douglas Beall,15 Stephen Hochschuler,16 Michael E Schatman,17,18 Timothy Lubenow,19 Richard Guyer,16,20 Ahmed M Raslan21 1The Spine and Nerve Center of the Virginias, Charleston, WV, USA; 2Weill Cornell Tri-Institutional Pain Medicine Program, Department of Anesthesiology, Weill Medical College of Cornell University, New York, NY, USA; 3Department of Anesthesiology and Pain Medicine, the University of Kansas Medical Center, Kansas City, KS, USA; 4Trinity Pain Medicine Associates, Fort Worth, TX, USA; 5Department of Physical Medicine and Rehabilitation, University of Missouri, Columbia, MO, USA; 6Lenox Hill Hospital, Northwell Health, New York, NY, USA; 7Department of Anesthesiology, University of Wisconsin, Madison, WI, USA; 8Interventional Pain Management, Mayo Clinic, Scottsdale, AZ, USA; 9Department of Anesthesiology and Perioperative Medicine, Division of Pain Medicine, Mayo Clinic, Rochester, MN, USA; 10Novant Health Spine Specialists, Charlotte, NC, USA; 11North Texas Orthopedics and Spine Center, Grapevine, TX, USA; 12Neuroradiology and Pain Solutions of Oklahoma, Oklahoma City, OK, USA; 13Department of Anesthesia, University of Pittsburgh Medical Center, Susquehanna, PA, USA; 14Crimson Pain Management, Overland Park, Kansas, KS, USA; 15Comprehensive Specialty Care, Edmond, OK, USA; 16Texas Back Institute, Plano, TX, USA; 17Department of Anesthesiology, Perioperative Care and Pain Medicine, NYU Grossman School of Medicine, New York, NY, USA; 18Department of Population Health – Division of Medical Ethics, NYU Grossman School of Medicine, New York, NY, USA; 19Department of Anesthesiology, Rush University Medical Center, Chicago, IL, USA; 20Department of Orthopedic Surgery, University of Texas Southwestern Medical School, Dallas, TX, USA; 21Department of Neurological Surgery, Oregon Health and Science University, Portland, OR, 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: The evolution of treatment options for painful spinal disorders in diverse settings has produced a variety of approaches to patient care among clinicians from multiple professional backgrounds. The American Society of Pain and Neuroscience (ASPN) Best Practice group identified a need for a multidisciplinary guideline regarding appropriate and effective informed consent processes for spine procedures.Objective: The ASPN Informed Consent Guideline was developed to provide clinicians with a comprehensive evaluation of patient consent practices during the treatment of spine pathology.Methods: After a needs assessment, ASPN determined that best practice regarding proper informed consent for spinal procedures was needed and a process of selecting faculty was developed based on expertise, diversity, and knowledge of the subject matter. A comprehensive literature search was conducted and when appropriate, evidence grading was performed. Recommendations were based on evidence when available, and when limited, based on consensus opinion.Results: Following a comprehensive review and analysis of the available evidence, the ASPN Informed Consent Guideline group rated the literature to assist with specification of best practice regarding patient consent during the management of spine disorders.Conclusion: Careful attention to informed consent is critical in achieving an optimal outcome and properly educating patients. This process involves a discussion of risks, advantages, and alternatives to treatment. As the field of interventional pain and spine continues to grow, it is imperative that clinicians effectively educate patients and obtain comprehensive informed consent for invasive procedures. This consent should be tailored to the patient’s specific needs to ensure an essential recognition of patient autonomy and reasonable expectations of treatment.Keywords: informed consent, best practice, clinical guideline, pain medicine, spine intervention, spine surgery

Corey W Hunter,1,2 Timothy R Deer,3 Mark R Jones,4 George Chiang Chien,5 Ryan S D’Souza,6 Timothy Davis,7 Erica R Eldon,2 Michael F Esposito,8 Johnathan H Goree,9 Lissa Hewan-Lowe,2 Jillian A Maloney,10 Anthony J Mazzola,2 John S Michels,4 Annie Layno-Moses,7 Shachi Patel,11 Jeanmarie Tari,1 Jacqueline S Weisbein,12 Krista A Goulding,13 Anikar Chhabra,13 Jeffrey Hassebrock,13 Chris Wie,10 Douglas Beall,14 Dawood Sayed,15 Natalie Strand10 1Ainsworth Institute of Pain Management, New York, NY, USA; 2Department of Rehabilitation & Human Performance, Icahn School of Medicine at Mount Sinai, New York, NY, USA; 3The Spine and Nerve Center of the Virginias, Charleston, WV, USA; 4Interventional Spine and Pain, Dallas, TX, USA; 5County Medical Center, Ventura, CA, USA; 6Department of Anesthesiology, Mayo Clinic, Rochester, MN, USA; 7Source Healthcare, Santa Monica, CA, USA; 8Interventional Spine and Pain Institute, Vero Beach, FL, USA; 9Department of Anesthesiology, University of Arkansas for Medical Sciences, Little Rock, AR, USA; 10Department of Anesthesiology, Division of Pain Medicine, Mayo Clinic, Phoenix, AZ, USA; 11Delmarva Pain and Spine Center, Newark, DE, USA; 12Napa Valley Orthopaedic Medical Group, Napa, CA, USA; 13Department of Orthopedic Surgery, Mayo Clinic, Phoenix, AZ, USA; 14Comprehensive Specialty Care, Oklahoma City, OK, USA; 15Department of Anesthesiology, Division of Pain Medicine, University of Kansas Medical Center, Kansas City, KS, USACorrespondence: Corey W Hunter, Email chunter@ainPain.comAbstract: Knee pain is second only to the back as the most commonly reported area of pain in the human body. With an overall prevalence of 46.2%, its impact on disability, lost productivity, and cost on healthcare cannot be overlooked. Due to the pervasiveness of knee pain in the general population, there are no shortages of treatment options available for addressing the symptoms. Ranging from physical therapy and pharmacologic agents to interventional pain procedures to surgical options, practitioners have a wide array of options to choose from – unfortunately, there is no consensus on which treatments are “better” and when they should be offered in comparison to others. While it is generally accepted that less invasive treatments should be offered before more invasive ones, there is a lack of agreement on the order in which the less invasive are to be presented. In an effort to standardize the treatment of this extremely prevalent pathology, the authors present an all-encompassing set of guidelines on the treatment of knee pain based on an extensive literature search and data grading for each of the available alternative that will allow practitioners the ability to compare and contrast each option.Keywords: knee, knee pain, genicular nerve, ablation, regenerative medicine, platelet-rich plasma, dorsal root ganglion, peripheral nerve stimulation

Oluwatodimu Richard Raji,1,2 Joshua H Tandio,1 Sarah Mayer,1 Alexander Escobar,3 Brett A Himmelwright,4 Douglas P Beall,5 David L Caraway,6 Jeremi M Leasure1,7 1Medical Device Development, San Francisco, CA, USA; 2Department of Orthopedics, UCSF Health St. Mary’s Hospital, San Francisco, CA, USA; 3University of Toledo Medical Center, Toledo, OH, USA; 4Orthopedic Institute of Pennsylvania, Camp Hill, PA, USA; 5Comprehensive Specialty Care, Edmond, OK, USA; 6Nevro Corporation, Redwood City, CA, USA; 7California State University College of Engineering, Northridge, CA, USACorrespondence: Oluwatodimu Richard Raji, Medical Device Development, San Francisco, CA, USA, Tel +1 510 570 7741, Email richardraji@mdevdev.comPurpose: To concurrently assess and compare the fixation efficacy, invasiveness, and fusion potential of a posterior integrated transfixation cage system to the posterolateral threaded implant and lateral triangular rod systems, in a cadaveric model.Methods and Materials: Twelve (12) cadaveric sacroiliac joint specimens were utilized and tested within the single-leg stance multidirectional pure moment bending model. Each specimen was tested in the intact, destabilized, treated (using posterior, posterolateral, and lateral systems), and post-fatigue conditions by applying 0 to ± 7.5 Nm of moment in flexion-extension, axial rotation, and lateral bending while measuring the angular range of motion between the sacrum and ilium. Computational models were reconstructed from Computed Tomography (CT) scans and manufacturer surgical technique guides. The models were utilized to quantify the volume of bone removed during implantation and the surface area available for fusion.Results: The posterior integrated transfixation cage system and the lateral triangular rods produced equivalent motion reduction in all motion planes (P > 0.583). The posterolateral cylindrical threaded implant produced less motion reductions than the posterior and lateral implants in flexion-extension (6% ± 3% vs 37% ± 10% and 33% ± 11%, respectively, P < 0.05). The posterior system removed 22%-60% less bone volume from the sacrum and ilium (P< 0.10), introduced 200%-270% more implant surface to the joint space (P< 0.01) and decorticated 75%-375% more joint surface area (P< 0.01).Conclusion: The posterior integrated transfixation single-implant cage system is superior to the posterolateral cylindrical threaded single-implant system. Its performance in osteopenic bone is equivalent to the lateral triangular rod system in healthy bone; however, the posterior integrated transfixation cage system requires a single implant, while the lateral triangular rod system requires three. The posterior implant removes the least bone volume and has the most surface area for fusion, providing a significantly better opportunity for robust sacroiliac joint arthrodesis.Keywords: arthrodesis, integrated fixation, bone volume, fatigue, durability, sacroiliac joint fusion

Dawood Sayed,1 Douglas P Beall,2 Amitabh Gulati,3 Eric Hyman,4 Jon E Block5 1KU Medical Center, Kansas City, KS, USA; 2Comprehensive Specialty Care, Edmond, OK, USA; 3Memorial Sloane Kettering, New York, NY, USA; 4HaA, Inc., Wakefield, MA, USA; 5Private Practice, San Francisco, CA, USACorrespondence: Jon E Block, Email jb@drjonblock.comBackground: A growing body of clinical evidence has demonstrated that intraosseous minimally invasive basivertebral nerve (BVN) ablation results in significant and durable improvements in vertebrogenic back pain. Thus, it is important to develop, refine and validate new and additional devices to accomplish this procedure.Methods: Using reconstructions of 31 patient computed tomography (CT) scans of the lumbosacral spine (L1-S1), the primary objective was to simulate the intravertebral placement of a novel multitined expandable electrode in bipolar configuration at the targeted ablation site and determine if the proper trajectories could be achieved in order for the device tips to be in the correct position for lesion formation at the BVN plexus. Successful device deployment required that the distance between tips was between 10 mm and 20 mm.Results: The mean distances between device tips ranged from 11.35 mm (L5) to 11.87 mm (L3), and there were no statistically significance differences across the six vertebral levels (F = 0.72, p = 0.61). The percentage of successful intraosseous device placements within the tip distance acceptable range (≥ 10 mm to ≤ 20 mm) was 90% (162 of 180), with no tip-to-tip distances > 20 mm. There was a notable association between decreasing vertebral level and mean degree of angulation between contralateral devices ranging from 50.90° at L1 to 91.51° at S1, and the difference between across the six vertebral levels was significant (F = 89.5, p < 0.01).Conclusion: Feasibility evidence is provided from real world CT imaging data that validates using the multitined electrode for proper intraosseous placement within the vertebral body to effectively ablate the BVN plexus.Keywords: vertebrogenic pain, basivertebral nerve, endplate, radiofrequency ablation, Subsidio, electrode, back pain

Ganesan Baranidharan,1,2 Beatrice Bretherton,1,3 Richard G Feltbower,4 Jake Timothy,5 Almas Latif Khan,6,7 Ashok Subramanian,8 Mushtaq Ahmed,9 Tracey A Crowther,1,10 Helen Radford,10,11 Harun Gupta,12 Muthusamy Chandramohan,13 Douglas P Beall,14 Timothy R Deer,15 Thomas Hedman16 1Pain Management Department, Leeds Teaching Hospitals NHS Trust, Leeds, UK; 2School of Medicine, University of Leeds, Leeds, UK; 3School of Biomedical Sciences, Faculty of Biological Sciences, University of Leeds, Leeds, UK; 4Leeds Institute for Data Analytics, School of Medicine, University of Leeds, Leeds, UK; 5Department of Neuroscience, Leeds Teaching Hospitals NHS Trust, Leeds, UK; 6Department of Spine Surgery, Leeds Teaching Hospitals NHS Trust, Leeds, UK; 7Institute of Medical and Biological Engineering, University of Leeds, Leeds, UK; 8Somerset Spinal Surgery Service, Musgrove Park Hospital, Taunton, UK; 9Department of Trauma and Orthopaedic Surgery, Dudley Group NHS Foundation Trust, Dudley, UK; 10Research & Innovation, Leeds Teaching Hospitals NHS Trust, Leeds, UK; 11Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK; 12Department of Radiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK; 13Radiology Department, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK; 14Comprehensive Specialty Care, Edmond, OK, USA; 15The Spine and Nerve Center of the Virginias, Charleston, WV, USA; 16Department of Biomedical Engineering, University of Kentucky, Lexington, KY, USACorrespondence: Ganesan Baranidharan, Pain Management Department, Leeds Teaching Hospitals NHS Trust, Leeds, UK, Email g.baranidharan@nhs.netPurpose: An early-stage, multi-centre, prospective, randomised control trial with five-year follow-up was approved by Health Research Authority to compare the efficacy of a minimally invasive, laterally implanted interspinous fixation device (IFD) to open direct surgical decompression in treating lumbar spinal stenosis (LSS). Two-year results are presented.Patients and Methods: Forty-eight participants were randomly assigned to IFD or decompression. Primary study endpoints included changes from baseline at 8-weeks, 6, 12 and 24-months follow-ups for leg pain (visual analogue scale, VAS), back pain (VAS), disability (Oswestry Disability Index, ODI), LSS physical function (Zurich Claudication Questionnaire), distance walked in five minutes and number of repetitions of sitting-to-standing in one minute. Secondary study endpoints included patient and clinician global impression of change, adverse events, reoperations, operating parameters, and fusion rate.Results: Both treatment groups demonstrated statistically significant improvements in mean leg pain, back pain, ODI disability, LSS physical function, walking distance and sitting-to-standing repetitions compared to baseline over 24 months. Mean reduction of ODI from baseline levels was between 35% and 56% for IFD (p< 0.002), and 49% to 55% for decompression (p< 0.001) for all follow-up time points. Mean reduction of IFD group leg pain was between 57% and 78% for all time points (p< 0.001), with 72% to 94% of participants having at least 30% reduction of leg pain from 8-weeks through 24-months. Walking distance for the IFD group increased from 66% to 94% and sitting-to-standing repetitions increased from 44% to 64% for all follow-up time points. Blood loss was 88% less in the IFD group (p=0.024) and operating time parameters strongly favoured IFD compared to decompression (p< 0.001). An 89% fusion rate was assessed in a subset of IFD participants. There were no intraoperative device issues or re-operations in the IFD group, and only one healed and non-symptomatic spinous process fracture observed within 24 months.Conclusion: Despite a low number of participants in the IFD group, the study demonstrated successful two-year safety and clinical outcomes for the IFD with significant operation-related advantages compared to surgical decompression.Keywords: lumbar spinal stenosis, surgical decompression, posterior lateral arthrodesis, patient reported outcomes, minimally invasive spine, interspinous fixation device

Morgan P Lorio,1 Jordan Lee Tate,2 Thomas J Myers,3 Jon E Block,4 Douglas P Beall5 1Advanced Orthopedics, Altamonte Springs, FL, USA; 2Southern Pain and Spine Associates, Jasper, GA, USA; 3Paradigm Health System, Slidell, LA, USA; 4Private Practice, San Francisco, CA, USA; 5Comprehensive Specialty Care, Edmond, OK, USACorrespondence: Jon E Block, Private Practice, 2210 Jackson Street, Ste. 401, San Francisco, CA, 94115, USA, Tel +1(415) 775-7947, Email jb@drjonblock.comAbstract: Specific clinical diagnostic criteria have established a consensus for defining patients with lumbar discogenic pain. However, if conservative medical management fails, these patients have few treatment options short of surgery involving discectomy often coupled with fusion or arthroplasty. There is a rapidly-emerging research effort to fill this treatment gap with intradiscal therapies that can be delivered minimally-invasively via fluoroscopically guided injection without altering the normal anatomy of the affected vertebral motion segment. Viable candidate products to date have included mesenchymal stromal cells, platelet-rich plasma, nucleus pulposus structural allograft, and other cell-based compositions. The objective of these products is to repair, supplement, and restore the damaged intervertebral disc as well as retard further degeneration. In doing so, the intervention is meant to eliminate the source of discogenic pain and avoid surgery. Methodologically rigorous studies are rare, however, and based on the best clinical evidence, the safety as well as the magnitude and duration of clinical efficacy remain difficult to estimate. Further, we summarize the US Food and Drug Administration’s (FDA) guidance regarding the interpretation of the minimal manipulation and homologous use criteria, which is central to designating these products as a tissue or as a drug/device/biologic. We also provide perspectives on the core evidence and knowledge gaps associated with intradiscal therapies, propose imperatives for evaluating effectiveness of these treatments and highlight several new technologies on the horizon.Keywords: degenerative, disc, intradiscal, autologous, allogeneic, injection, regenerative, discogenic, pain

Tyree D Williams,1– 3 Talia Adler,2,4 Lindsey Smokoff,2,4 Anmoldeep Kaur,2,5 Benjamin Rodriguez,2,3,6 Kavita Jyoti Prakash,6 Edib Redzematovic,2 Turner S Baker,2,3,7 Benjamin I Rapoport,2,3 Edward S Yoon,8 Douglas P Beall,9 Jonathan S Dordick,1 Reade A De Leacy3 1Biomedical Engineering, Rensselaer Polytechnic Institute, Troy, NY, USA; 2Sinai BioDesign, Mount Sinai Medical System, New York, NY, USA; 3Department of Neurosurgery, Mount Sinai Medical System, New York, NY, USA; 4Columbia University School of General Studies, New York, NY, USA; 5Department of Neuroscience, Smith College, Northampton, MA, USA; 6Icahn School of Medicine at Mount Sinai, New York, NY, USA; 7Department of Population Health Science & Policy, Icahn School of Medicine at Mount Sinai, New York, NY, USA; 8Hospital for Special Surgery, New York, NY, USA; 9Spine Fracture Institute, Oklahoma City, OK, USACorrespondence: Benjamin Rodriguez, Department of Neurosurgery, Mount Sinai Medical System, One Gustave L. Levy Place, Box 1136, New York, NY, USA, Tel +1 615 524-0211, Email tyree.williams@mssm.eduAbstract: Vertebral compression fractures (VCFs) are common in osteoporotic patients, with a frequency projected to increase alongside a growing geriatric population. VCFs often result in debilitating back pain and decreased mobility. Cement augmentation, a minimally invasive surgical technique, is widely used to stabilize fractures and restore vertebral height. Acrylic-based cements and calcium phosphate cements are currently the two primary fill materials utilized for these procedures. Despite their effectiveness, acrylic bone cements and calcium phosphate cements have been associated with various intraoperative and postoperative incidents impacting VCF treatment. Over the past decade, discoveries in the field of biomedical engineering and material science have shown advancements toward addressing these limitations. This narrative review aims to assess the potential pitfalls and barriers of the various types of bone cements.Keywords: osteoporosis, vertebral compression fractures, bone cement, vertebroplasty, kyphoplasty, vertebral augmentation

Anuj Shah,1 Jonathan M Hagedorn,2 Usman Latif,3 Ashley Bailey-Classen,4 Nomen Azeem,5 Douglas P Beall,6 Pankaj Mehta,7 Chad Stephens,8 Larry Khoo,9 Timothy Ray Deer10 1Department of Physical Medicine and Rehabilitation, Detroit Medical Center, Detroit, MI, USA; 2Department of Anesthesiology and Perioperative Medicine, Division of Pain Medicine, Mayo Clinic, Rochester, MN, USA; 3Department of Anesthesiology and Pain Medicine, University of Kansas Health System, Kansas City, KS, USA; 4Trinity Pain Medicine Associates, Fort Worth, TX, USA; 5Florida Spine & Pain Specialists, Riverview, FL, USA; 6Comprehensive Specialty Care, Edmond, OK, USA; 7Pain Specialists of Austin and Central Texas Pain Center, Austin, TX, USA; 8Noble Pain Management and Sports Medicine, Southlake, TX, USA; 9The Spine Clinic of Los Angeles, Los Angeles, CA, USA; 10The Spine and Nerve Center of the Virginias, Charleston, WV, USACorrespondence: Anuj Shah, Department of Physical Medicine and Rehabilitation, Detroit Medical Center, 261 Mack Ave, Detroit, MI, 48220, USA, Tel +1 734646-0321, Email Anujshah74@gmail.comIntroduction: Lumbar spinal stenosis (LSS) is a common condition caused by degenerative changes in the lumbar spine with age. LSS is caused by a variety of factors, including degenerative spondylosis and spondylolisthesis. People suffering with LSS experience neurogenic claudication, which causes severe physical limitations, discomfort, and a decrease in quality of life. Less invasive procedures are now being researched to improve the prognosis, success rate, and safety of LSS treatments. Posterior lateral spinal arthrodesis (PLSA) is a new surgical treatment for LSS. This study looks at the procedural and patient safety of PLSA.Materials and methods: This study is a multicenter retrospective analysis of the safety of PLSA who met the clinical indications for PLSA and underwent the procedure at eight interventional spine practices. Data was collected on demographical information, pre-procedural numeric rating scale score (NRS), post-procedural NRS, and complication reporting. Patients who were included had LSS with or without spondylolisthesis and had failed conservative treatments. A descriptive statistical analysis was performed to report the outcomes. Results were reported as mean and standard deviations for continuous outcomes, and frequency (%) for categorical outcomes.Results: This retrospective analysis involved 191 patients and 202 PLSA implants. The majority of patients were male Caucasians with a mean age of 69.2 years and a BMI of 31.1. A large majority of implants were placed at the L4-5 level, and the average pre-procedural NRS was 6.3 while the average post-procedural NRS was 3.1, indicating a 50.8% reduction in pain (p < 0.0001). Two patients reported complications, but they were unrelated to the device or surgical procedure; no infections, device malfunctions, or migrations were reported in the patient cohort.Conclusion: Preliminary results with PLSA implants indicate that it is a safe treatment option for patients with moderate LSS who do not respond to conservative management.Keywords: lumbar spinal stenosis, spondylolisthesis, interspinous fusion, Minuteman, spinal simplicity, posterior lateral spinal arthrodesis

Matthew Skoblar,1 Thomas Hedman,2,3 Adam J Rogers,3 Gabriel P Jasper,1 Douglas P Beall4 1The Jasper Spine Institute, Brick Township, NJ, USA; 2University of Kentucky, Lexington, KY, USA; 3Spinal Simplicity LLC, Overland Park, KS, USA; 4Comprehensive Specialty Care, Edmond, OK, USACorrespondence: Douglas P Beall, Interventional Radiology, Comprehensive Specialty Care, 1023 Waterwood Pkwy, Edmond, OK, 73034, USA, Tel +1 (405) 601-2325 ; +1 (405) 213-9639, Email db@clinrad.orgPurpose: Prospective evaluation of radiographic fusion outcomes in patients receiving instrumented posterior arthrodesis of the lumbar spine using a minimally invasive interspinous fixation device.Patients and Methods: All patients (n = 110) from a single US physician’s practice who received instrumented posterior arthrodesis of the lumbar spine with a minimally invasive interspinous fixation device in the calendar year 2020 were invited to return for a follow-up CT scan to radiographically assess fusion. Forty-three patients, representing 69 total treated levels, consented to participate and received a lumbar CT scan at a mean of 459 days post-surgery (177 to 652). The interspinous/interlaminar fusion was assessed by 3 independent radiologists using a novel grading scale. Spinous process fractures were also assessed.Results: 92.8% of the assessed levels were considered fused. There were no intraoperative spinous process fractures. There were 4 spinous process fractures (5.8%) identified on CT imaging, all of which were asymptomatic and healed without subsequent intervention. There were no instances of device mechanical failure or device-related reoperation.Conclusion: Instrumented posterior arthrodesis of the lumbar spine using a minimally invasive interspinous fixation device provides clinically meaningful fusion rates with no reoperations and a low risk of spinous process fracture or other device-related complications.Keywords: interspinous fusion, fusion grading scale, ligament sparing, spinal stenosis

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

Timothy R Deer,1 Douglas P Beall,2 Steven M Falowski3 1The Spine and Nerve Center of The Virginias, Charleston, WV 25301, USA; 2Comprehensive Specialty Care, Edmond, OK, 73103, USA; 3Argires Marotti Neurosurgical Associates of Lancaster, Lancaster, PA 17601, USACorrespondence: Steven M Falowski, Argires Marotta Neurosurgical Associates of Lancaster, Lancaster, PA, 17601, USA, Tel +1 717-358-0800, Email sfalowski@gmail.com

Genipin polymers are self-forming tensile-load-carrying oligomers, derived from the gardenia fruit, that covalently bond to amines on collagen. The potential therapeutic mechanical benefits of a non-discrete in situ forming mesh of genipin oligomers for degraded spinal discs were first conceived in 1998. Over more than two decades, numerous studies have demonstrated the immediate mechanical effects of this injectable, intra-annular polymeric mesh including an early demonstration of an effect on clinical outcomes for chronic or recurrent discogenic low back pain. This literature review focused on articles investigating mechanical effects in cadaveric animal and human spinal discs, biochemical mechanism of action studies, articles describing the role of mechanical degradation in the pathogenesis of degenerative disc disease, initial clinical outcomes and articles describing current discogenic low back pain treatment algorithms. On the basis of these results, clinical indications that align with the capabilities of this novel injectable polymer-based treatment strategy are discussed. It is intended that this review of a novel nano-scale material-based solution for mechanical deficiencies in biologically limited tissues may provide a helpful example for other innovations in spinal diseases and similarly challenging musculoskeletal disorders.

Vertebral augmentation has been used to treat painful vertebral compression fractures and metastatic lesions in millions of patients around the world. An international group of subject matter experts have considered the evidence, including but not limited to mortality. These considerations led them to ask whether it is appropriate to allow the subjective measure of pain to so dominate the clinical decision of whether to proceed with augmentation. The discussions that ensued are related below.

Objective: To assess long-term outcomes of cooled radiofrequency ablation (CRFA) of genicular nerves for chronic knee pain due to osteoarthritis (OA)., Methods: A prospective, observational extension of a randomized, controlled trial was conducted on adults randomized to CRFA. Subjects were part of a 12-month clinical trial comparing CRFA of genicular nerves to a single hyaluronic injection for treatment of chronic OA knee pain, who then agreed to visits at 18- and 24-months post CRFA and had not undergone another knee procedure since. The subjects were evaluated for pain using the Numeric Rating Scale (NRS) function using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), subjective benefit using the Global Perceived Effect (GPE) scale, quality of life using the EuroQol-5-Dimensions-5 Level (EQ-5D-5L) questionnaire, and safety., Results: Of 57 subjects eligible, 36 enrolled; 32 completed the 18-month visit with a mean NRS score of 2.4 and 22 (69%) reporting ≥50% reduction in pain from baseline (primary endpoint); 27 completed the 24-month visit, with a mean NRS of 3.4 and 17 (63%) reporting ≥50% pain relief. Functional and quality of life improvements persisted similarly, with mean changes from baseline of 53.5% and 34.9% in WOMAC total scores, and 24.8% and 10.7% in EQ-5D-5L Index scores, at 18- and 24-months, respectively. There were no identified safety concerns in this patient cohort., Conclusion: In this subset of subjects, CRFA of genicular nerves provided durable pain relief, improved function, and improved quality of life extending to 24 months post procedure, with no significant safety concerns., (© 2022 The Authors. Pain Practice published by Wiley Periodicals LLC on behalf of World Institute of Pain.)