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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

Ryan S D’Souza,1 Yeng F Her,1 Nasir Hussain,2 Jay Karri,3 Michael E Schatman,4 Aaron K Calodney,5 Christopher Lam,6 Thomas Buchheit,7 Brennan J Boettcher,8 George C Chang Chien,9 Scott G Pritzlaff,10 Christopher Centeno,11 Shane A Shapiro,12 Johana Klasova,1 Jay S Grider,13 Ryan Hubbard,14 Eliana Ege,15 Shelby Johnson,8 Max H Epstein,16 Eva Kubrova,8 Mohamed Ehab Ramadan,17 Alexandra Michelle Moreira,18 Swarnima Vardhan,19 Yashar Eshraghi,20 Saba Javed,21 Newaj M Abdullah,22 Paul J Christo,17 Sudhir Diwan,23 Leslie C Hassett,24 Dawood Sayed,6 Timothy R Deer25 1Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN, USA; 2Department of Anesthesiology, The Ohio State Wexner Medical Center, Columbus, OH, USA; 3Departments of Orthopedic Surgery and Anesthesiology, University of Maryland School of Medicine, Baltimore, MD, USA; 4Department of Anesthesiology, Perioperative Care, & Pain Medicine, NYU Grossman School of Medicine, New York, NY, USA; 5Precision Spine Care, Tyler, TX, USA; 6Department of Anesthesiology and Pain Medicine, The University of Kansas Medical Center, Kansas City, KS, USA; 7Department of Anesthesiology, Duke University, Durham, NC, USA; 8Department of Physical Medicine and Rehabilitation, Mayo Clinic, Rochester, MN, USA; 9Department of Regenerative Medicine, GCC Institute, Torrance, CA, USA; 10Department of Anesthesiology and Pain Medicine, University of California, Davis, Sacramento, CA, USA; 11Centeno-Schultz Clinic, Broomfield, CO, USA; 12Department of Orthopedic Surgery, Mayo Clinic, Jacksonville, FL, USA; 13Department of Anesthesiology, University of Kentucky College of Medicine, Lexington, KY, USA; 14Department of Sports Medicine, Anderson Orthopedic Clinic, Arlington, VA, USA; 15Department of Physical Medicine & Rehabilitation, Baylor College of Medicine, Houston, TX, USA; 16Department of Physical Medicine & Rehabilitation, Harvard Medical School, Boston, MA, USA; 17Department of Anesthesiology and Critical Care Medicine, Johns Hopkins Hospital, Baltimore, MD, USA; 18Department of Physical Medicine & Rehabilitation, University of Miami/Jackson Memorial Hospital, Miami, FL, USA; 19Department of Internal Medicine, Yale New Haven Health – Bridgeport Hospital, Bridgeport, CT, USA; 20Department of Anesthesiology & Critical Care Medicine, Ochsner Health System, New Orleans, LA, USA; 21Department of Pain Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA; 22Department of Anesthesiology, University of Utah, Salt Lake City, UT, USA; 23Department of Pain Medicine, Advanced Spine on Park Avenue, New York City, NY, USA; 24Mayo Clinic Libraries, Mayo Clinic, Rochester, MN, USA; 25Department of Anesthesiology and Pain Medicine, West Virginia University School of Medicine, Charleston, WV, USACorrespondence: Ryan S D’Souza, Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, 200 First St. SW, Rochester, MN, 55905, USA, Tel +1-(507)-284-9696, Fax +1-(507)-266-7732, Email dsouza.ryan@mayo.eduPurpose: Injectable biologics have not only been described and developed to treat dermal wounds, cardiovascular disease, and cancer, but have also been reported to treat chronic pain conditions. Despite emerging evidence supporting regenerative medicine therapy for pain, many aspects remain controversial.Methods: The American Society of Pain and Neuroscience (ASPN) identified the educational need for an evidence-based guideline on regenerative medicine therapy for chronic pain. The executive board nominated experts spanning multiple specialties including anesthesiology, physical medicine and rehabilitation, and sports medicine based on expertise, publications, research, and clinical practice. A steering committee selected preliminary questions, which were reviewed and refined. Evidence was appraised using the United States Preventive Services Task Force (USPSTF) criteria for evidence level and degree of recommendation. Using a modified Delphi approach, consensus points were distributed to all collaborators and each collaborator voted on each point. If collaborators provided a decision of “disagree” or “abstain”, they were invited to provide a rationale in a non-blinded fashion to the committee chair, who incorporated the respective comments and distributed revised versions to the committee until consensus was achieved.Results: Sixteen questions were selected for guideline development. Questions that were addressed included type of injectable biologics and mechanism, evidence in treating chronic pain indications (eg, tendinopathy, muscular pathology, osteoarthritis, intervertebral disc disease, neuropathic pain), role in surgical augmentation, dosing, comparative efficacy between injectable biologics, peri-procedural practices to optimize therapeutic response and quality of injectate, federal regulations, and complications with mitigating strategies.Conclusion: In well-selected individuals with certain chronic pain indications, use of injectable biologics may provide superior analgesia, functionality, and/or quality of life compared to conventional medical management or placebo. Future high-quality randomized clinical trials are warranted with implementation of minimum reporting standards, standardization of preparation protocols, investigation of dose–response associations, and comparative analysis between different injectable biologics.Keywords: regenerative medicine, injectable biologics, platelet-rich plasma, mesenchymal stem cell, bone marrow aspirate concentrate, pain medicine

Aaron Calodney,1 Nomen Azeem,2 Patrick Buchanan,3 Ioannis Skaribas,4 Ajay Antony,5 Christopher Kim,6 George Girardi,7 Chau Vu,8 Christopher Bovinet,9 Rainer Vogel,10 Sean Li,11 Navdeep Jassal,12 Youssef Josephson,13 Timothy Lubenow,14 Christopher M Lam,15 Timothy R Deer6 1Precision Spine Care, Tyler, TX, USA; 2Florida Spine and Pain Specialists, Tampa, FL, USA; 3Spanish Hills Interventional Pain Specialists, Camarillo, CA, USA; 4Expert Pain P.A, Houston, TX, USA; 5The Orthopaedic Institute, Gainesville, FL, USA; 6The Spine and Nerve Center, Charleston, WV, USA; 7Front Range Pain Medicine, Fort Collins, CO, USA; 8Evolve Restoration Center, Santa Rosa, CA, USA; 9The Spine Center of Southeast Georgia, Brunswick, GA, USA; 10Comprehensive and Interventional Pain Management, Henderson, NV, USA; 11Premier Pain Centers, Shrewsbury, NJ, USA; 12Excel Pain and Spine, Lakeland, FL, USA; 13The Pain Management Center, Voorhees Township, NJ, USA; 14Rush University Medical Center, Chicago, IL, USA; 15University of Kansas Medical Center, Kansas City, KS, USACorrespondence: Aaron Calodney, Precision Spine Care, Tyler, TX, USA, Email aaroncalodney@me.comIntroduction: Research suggests that sacroiliac joint (SIJ) dysfunction is responsible for 15% to 30% of reported low back pain cases. Recently, there has been an increasing interest in SIJ fusion using minimally invasive surgery (MIS) due to safety. Initially, devices designed for MIS were intended for lateral approaches. A minimally invasive sacroiliac fusion implant for use with a posterior approach has been developed and is regulated for clinical use under the regulatory framework required for human cells, tissues, or cellular or tissue-based products (HCT/Ps).Methods: A multi-center, prospective, single-arm study was launched after initial studies provided preliminary data to support safety, efficacy, and durability of this minimally invasive sacroiliac posterior fusion LinQ allograft implant (NCT04423120). Preliminary results were reported previously. Final results for the full participant cohort are presented here.Results: One-hundred and fifty-nine (159) participants were enrolled across 16 investigational sites in the US between January 2020 and March 2022. One-hundred and twenty-two (122) participants were implanted. At the 1-month follow-up, 82 participants satisfied all criteria for the composite responder endpoint, representing 73.2% of the study cohort. These results stayed consistent across the remaining study timepoints with 66.0%, 74.4%, and 73.5% of participants classified as responders at the 3-, 6- and 12-month follow-up visits, respectively. VAS scores were significantly reduced (p < 0.0001) and ODI scores were significantly improved (p < 0.0001). All domains of the PROMIS-29 were also significantly improved (all p’s < 0.0001). Only one procedure-related serious AE was reported in the study.Conclusion: These results suggest that the posterior approach LinQ Implant System is a safe and effective treatment for sacroiliac joint dysfunction at 12 months, with results that are favorable compared to outcomes reported for an FDA-cleared lateral approach.Keywords: sacroiliac joint disease, sacroiliac fusion, single point posterior fusion, back pain, minimally invasive spine surgery, sacroiliitis

Leonardo Kapural,1 Aaron Calodney2 1Carolinas Pain Institute, Winston-Salem, NC, USA; 2Precision Spine Care, Tyler, TX, USACorrespondence: Leonardo Kapural, Email lkapuralmd@gmail.comBackground: Non-surgical refractory back pain (NSRBP) is persistent, severe back pain that is not considered surgically correctable. Published studies have demonstrated clinically important long-term improvement in pain and functional capacity when 10kHz spinal cord stimulation (SCS) is used to treat NSRBP. This study examines if real-world patients in interventional pain practice obtain the same outcomes, and have any reduction in health care utilization (HCU) following 10kHz SCS implant.Methods: We conducted a retrospective chart review of 105 patients from two clinical sites who underwent implantation of 10kHz SCS for NSRBP. The three most frequent diagnoses were lumbosacral radiculopathy, degenerative disc disease (DDD)/discogenic back pain and foraminal stenosis. The complete set of patient-level electronic data, including clinical outcomes, HCU, and at least 12 months (12M) follow-up were available in 90 subjects.Results: The 90 analyzed patients were 63.9 years old (median 67) with an average of 10.2 years since back pain diagnosis. Reported pain on the Visual Analog Scale (VAS) decreased from 7.78± 1.3 cm to 3.4± 2.4 cm at 12M after SCS implant (p< 0.001). Opioid usage (n = 65) decreased from 57.9± 89.9 mg to 34.3± 66.4 mg MSO4 equivalents (p = 0.004) at 12M. There were 46 patients on various doses of anticonvulsants, mostly gabapentin. The average dose decreased from 1847.91± 973.6 mg at baseline to 1297.9± 1184.6 mg at 12M after implant (p = 0.016). HCU was analyzed comparing the 12M before to the 12M after implant. Number of office visits decreased from 10.83± 8.0 per year to 8.86± 7.64 (p = 0.036), number of procedures to control chronic pain decreased from 2.2± 1.9 to 0.6± 1.2 (p< 0.001). There was no significant change in number of imaging procedures, hospital admissions, or days spent in the hospital.Conclusion: 10kHz SCS warrants consideration as a therapeutic option for NSRBP patients and appears to provide a substantial reduction in HCU in the year following implant.Keywords: spinal cord stimulation, high-frequency 10 kHz spinal cord stimulation, neuromodulation, lower back pain, lumbosacral radiculopathy, non-surgical refractory back pain, discogenic back pain, SCS, NSRBP

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.

PURPOSE: Injectable biologics have not only been described and developed to treat dermal wounds, cardiovascular disease, and cancer, but have also been reported to treat chronic pain conditions. Despite emerging evidence supporting regenerative medicine therapy for pain, many aspects remain controversial. METHODS: The American Society of Pain and Neuroscience (ASPN) identified the educational need for an evidence-based guideline on regenerative medicine therapy for chronic pain. The executive board nominated experts spanning multiple specialties including anesthesiology, physical medicine and rehabilitation, and sports medicine based on expertise, publications, research, and clinical practice. A steering committee selected preliminary questions, which were reviewed and refined. Evidence was appraised using the United States Preventive Services Task Force (USPSTF) criteria for evidence level and degree of recommendation. Using a modified Delphi approach, consensus points were distributed to all collaborators and each collaborator voted on each point. If collaborators provided a decision of disagree or abstain, they were invited to provide a rationale in a non-blinded fashion to the committee chair, who incorporated the respective comments and distributed revised versions to the committee until consensus was achieved. RESULTS: Sixteen questions were selected for guideline development. Questions that were addressed included type of injectable biologics and mechanism, evidence in treating chronic pain indications (eg, tendinopathy, muscular pathology, osteoarthritis, intervertebral disc disease, neuropathic pain), role in surgical augmentation, dosing, comparative efficacy between injectable biologics, peri-procedural practices to optimize therapeutic response and quality of injectate, federal regulations, and complications with mitigating strategies. CONCLUSION: In well-selected individuals with certain chronic pain indications, use of injectable biologics may provide superior analgesia, functionality, and/or quality of life compared to conventional medical management or placebo. Future high-quality randomized clinical trials are warranted with implementation of minimum reporting standards, standardization of preparation protocols, investigation of dose-response associations, and comparative analysis between different injectable biologics.

IntroductionVertebral endplates, innervated by the basivertebral nerve (BVN), are a source of chronic low back pain correlated with Modic changes. A randomized trial comparing BVN ablation to standard care (SC) recently reported results of an interim analysis. Here, we report the results of the full randomized trial, including the 3-month and 6-month between-arm comparisons, 12-month treatment arm results, and 6-month outcomes of BVN ablation in the former SC arm.MethodsProspective, open label, 1:1 randomized controlled trial of BVN ablation versus SC in 23 US sites with follow-up at 6 weeks, 3, 6, 9, and 12 months. SC patients were re-baselined and followed up for 6 months post BVN ablation. The primary endpoint was the between-arm comparison of mean Oswestry Disability Index (ODI) change from baseline. Secondary endpoints were Visual Analog Scale (VAS), Short Form (SF-36), EuroQual Group 5 Dimension 5-Level Quality of Life (EQ-5D-5L), responder rates, and rates of continued opioid use.Results140 were randomized. Results from BVN ablation (n=66) were superior to SC (n=74) at 3 months for the primary endpoint (mean ODI reduction, difference between arms of -20.3 (CI -25.9 to -14.7 points; p

Objective: The MOTION study is designed to measure the impact of percutaneous image‐guided lumbar decompression as a first‐line therapy on patients otherwise receiving real‐world conventional medical management for lumbar spinal stenosis with neurogenic claudication secondary to hypertrophic ligamentum flavum. This prospective, multicenter randomized controlled trial uses objective and patient‐reported outcome measures to compare the combination of the mild® percutaneous treatment and nonsurgical conventional medical management (CMM) to CMM‐Alone. Methods: Test group patients received the mild procedure after study enrollment. Test and control groups were allowed conventional conservative therapies and low‐risk interventional therapies as recommended by their physicians. Subjective outcomes included the Oswestry Disability Index, Numeric Pain Rating Scale, and Zurich Claudication Questionnaire. Objective outcomes included a validated Walking Tolerance Test, the rate of subsequent lumbar spine interventions, and safety data. Results: Two‐year follow‐up included 64 mild + CMM and 67 CMM‐Alone patients. All outcome measures showed significant improvement from baseline for mild + CMM, whereas the majority of CMM‐Alone patients had elected to receive mild treatment or other lumbar spine interventions by 2 years, precluding valid 2‐year between‐group comparisons. Neither group reported any device‐ or procedure‐related adverse events. Conclusions: The durability of mild + CMM for this patient population was demonstrated for all efficacy outcomes through 2 years. Improvements in walking time from baseline to 2 years for patients treated with mild + CMM were significant and substantial. The lack of reported device or procedure‐related adverse events reinforces the strong safety profile of the mild procedure. These results provide support for early interventional treatment of symptomatic LSS with the mild procedure. [ABSTRACT FROM AUTHOR]