An Evidence-Based Consensus for the Use of Neurostimulation for the Treatment of Non-Surgical Low Back Pain: The NEURON Group

Timothy Ray Deer,1 Jason E Pope,2 Erika A Petersen,3 Rany T Abdallah,4 Kasra Amirdelfan,5 Nomen Azeem,6 Vishal Bansal,7 Kaku Barkoh,8 Kenneth B Chapman,9,10 Daniel R Denis,11 Michael J Dorsi,12 Alexander Escobar,13 Steven Michael Falowski,14 Rosa Amelia Garcia,15 Jonathan M Hagedorn,16 Robert D Heros,17 Whitney S James,18 Hemant Kalia,19 Todd Lansford,20 Mark N Malinowski,21 Suzanne Marie Manzi,22 Pankaj Mehta,23 Robert Z Moghim,24 Gregory Anthony Moore,25 Soriaya Lizette Motivala,26 Yeshvant A Navalgund,27 Raj G Patel,28 Julie G Pilitsis,29 Michael E Schatman,30,31 Philip Michael Shumsky,32 Natalie Holmes Strand,33 Nestor D Tomycz,34 James J Yue,35 Dawood Sayed36 1Pain Services, Spine and Nerve Center of the Virginias, Charleston, WV, USA; 2Evolve Restorative Center, Santa Rosa, CA, USA; 3Department of Neurosurgery, University of Arkansas for Medical Sciences, Little Rock, AR, USA; 4Pain Management, Apico Pain Management, Bear, DE, USA; 5Director of Clinical Research, Boomerang Healthcare, Walnut Creek, CA, USA; 6Pain Medicine, Florida Spine & Pain Specialists, Riverview, FL, USA; 7Department of Pain Medicine, the University of Texas MD Anderson Cancer Center, Houston, TX, USA; 8Orthopaedic Associates, Houston, TX, USA; 9Department of Anesthesiology, NYU Langone Medical Center, New York, NY, USA; 10Department of Anesthesiology, the Zucker School of Medicine at Northwell, New York, NY, USA; 11Neurosurgery, Ochsner Health, New Orleans, LA, USA; 12Neurosurgery, University of California Los Angeles, Los Angeles, CA, USA; 13Anesthesiology and Pain Medicine, University of Toledo, Toledo, OH, USA; 14Neurosurgery, Neurosurgical Associates of Lancaster, Lancaster, PA, USA; 15Department of Pain Medicine, University of Florida, Gainsville, FL, USA; 16Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN, USA; 17Spinal Diagnostics, Tualatin, OR, USA; 18Neurosurgery, James-Marco Health, Prescott, AZ, USA; 19Center for Research & Innovation in Spine & Pain (CRISP), Rochester, NY, USA; 20South Carolina Sports Medicine, Charleston, SC, USA; 21OhioHealth Neurological Physicians, OhioHealth, Columbus, OH, USA; 22Physician Co-Owner, Performance Pain and Sports Medicine, Houston, TX, USA; 23Division of Pain and Minimally Invasive Surgery, Pain Specialists of America, Austin, TX, USA; 24Interventional Spine and Pain, Colorado Pain Care, Denver, CO, USA; 25Pacific Sports and Spine, Eugene, OR, USA; 26Department of Neurosurgery, Northwell Health, New York, NY, USA; 27Office of the Chief Medical Officer, National Spine and Pain Centers, Frederick, MD, USA; 28Interventional Pain Management, Capitol Pain Institute, Austin, TX, USA; 29Department of Clinical Neurosciences, Florida Atlantic University, Boca Raton, FL, USA; 30Department of Anesthesiology, Perioperative Care & Pain Medicine, NYU Grossman School of Medicine, New York, NY, USA; 31Department of Population Health – Division of Medical Ethics, NYU Grossman School of Medicine, New York, NY, USA; 32Anesthesiology and Pain Medicine, Evolve Restorative Center, Santa Rosa, CA, USA; 33Anesthesiology and Pain Medicine, Mayo Clinic, Phoenix, AZ, USA; 34Neurological Surgery, Allegheny Health Network, Pittsburgh, PA, USA; 35Frank h Netter School of Medicine, Quinnipiac University; CT Orthopaedics, Hamden, CT, USA; 36Anesthesiology and Pain Medicine, the University of Kansas Medical Center, Kansas City, KS, USACorrespondence: Timothy Ray Deer, Spine and Nerve Center of the Virginias, 400 Court Street, Suite 100, Charleston, West Virginia, 25304, USA, Tel +1 304 347-6141, Email [email protected]: The use of electrical neuromodulation has often been limited to those with previous back surgery, peripheral neuropathy, and complex regional pain syndrome. Many patients with severe intractable low back pain were thought to be candidates for spinal cord stimulation (SCS), dorsal root ganglion stimulation, or peripheral nerve stimulation but did not meet the criteria. Recently, additional high-level data has supported the use of SCS in non-surgical low back pain (NSLBP), and United States Food and Drug Administration approval has been granted. The American Society of Pain and Neuroscience (ASPN) executive committee realized an unmet need to develop criteria for patient selection for this specific patient population. This is a NEURON project (neuroscience, education, utilization, risk mitigation, optimal outcomes, and neuromodulation), a living guideline for evolving therapies and indications, and is focused on the use of neuraxial stimulation for the treatment of refractory pain.Methods: After board approval, the society accepted nominees for the project, with an emphasis on experience, publication, research, and diversity. The team created an outline for discussion, chose a grading system based on published guidelines, and created consensus points.Results: The evidence led to several consensus points to best guide patient selection based on the level of evidence and expert opinion. The results will lead to improved safety and efficacy in implanted patients, and to a new standard for best practices.Conclusion: The selection of patients for implantation in those who have NSLBP should be based on published literature, best practice, and expert opinion. This NEURON project will allow for regular updates to create a living guideline that will allow for better assimilation of information to improve safety and efficacy going forward.Keywords: spinal cord stimulation, SCS, low back pain, lumbar degenerative disc disease, non-surgical back, non-surgical low back pain, NSLBP, failed back surgery syndrome, dorsal root ganglion stimulation, DRG, DRG-S, peripheral nerve stimulation, PNS