Does a Screening Trial for Spinal Cord Stimulation in Patients with Chronic Pain of Neuropathic Origin have Clinical Utility and Cost-Effectiveness? (TRIAL-STIM Study): study protocol for a randomised controlled trial

Abstract Background The TRIAL-STIM Study aims to assess the diagnostic performance, clinical outcomes and cost-effectiveness of a screening trial prior to full implantation of a spinal cord stimulation (SCS) device. Methods/design The TRIAL-STIM Study is a superiority, parallel-group, three-centre, randomised controlled trial in patients with chronic neuropathic pain with a nested qualitative study and economic evaluation. The study will take place in three UK centres: South Tees Hospitals NHS Foundation Trust (The James Cook University Hospital); Basildon and Thurrock University Hospitals NHS Foundation Trust; and Leeds Teaching Hospitals NHS Trust. A total of 100 adults undergoing SCS implantation for the treatment of neuropathy will be included. Subjects will be recruited from the outpatient clinics of the three participating sites and randomised to undergo a screening trial prior to SCS implant or an implantation-only strategy in a 1:1 ratio. Allocation will be stratified by centre and minimised on patient age (≥ 65 or < 65 years), gender, presence of failed back surgery syndrome (or not) and use of high frequency (HF10™) (or not). The primary outcome measure is the numerical rating scale (NRS) at 6 months compared between the screening trial and implantation strategy and the implantation-only strategy. Secondary outcome measures will include diagnostic accuracy, the proportion of patients achieving at least 50% and 30% pain relief at 6 months as measured on the NRS, health-related quality-of-life (EQ-5D), function (Oswestry Disability Index), patient satisfaction (Patients’ Global Impression of Change) and complication rates. A nested qualitative study will be carried out in parallel for a total of 30 of the patients recruited in each centre (10 at each centre) to explore their views of the screening trial, implantation and overall use of the SCS device. The economic evaluation will take the form of a cost–utility analysis. Discussion The TRIAL-STIM Study is a randomised controlled trial with a nested qualitative study and economic evaluation aiming to determine the clinical utility of screening trials of SCS as well as their cost-effectiveness. The nested qualitative study will seek to explore the patient’s view of the screening trials, implantation and overall use of SCS. Trial registration ISRCTN, ISRCTN60778781. Registered on 15 August 2017

American Society of Pain and Neuroscience Best Practice (ASPN) Guideline for the Treatment of Sacroiliac Disorders

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

American Society of Pain and Neuroscience Best Practice (ASPN) Guideline for the Treatment of Sacroiliac Disorders [Response to Letter]

Dawood Sayed,1 Timothy R Deer,2,3 Vinicius Tieppo Francio,1 Christopher M Lam,1 Kamil Sochacki,4 Nasir Hussain,5 Tristan E Weaver,5 Jay Karri,6,7 Vwaire Orhurhu,8,9 Natalie Holmes Strand,10 Jacqueline Soicher Weisbein,11 Jonathan M Hagedorn,12 Ryan S D&rsquo;Souza,12 Ryan R Budwany,2 Ahish Chitneni,13 Kasra Amirdelfan,14 Michael J Dorsi,15 Dan TD Nguyen,16 Christopher Bovinet,17 Alaa Abd-Elsayed18 1Anesthesiology and Pain Medicine, The University of Kansas Medical Center, Kansas City, KS, USA; 2Pain Services, Spine and Nerve Center of the Virginias, Charleston, WV, USA; 3Anesthesiology and Pain Medicine, West Virginia University School of Medicine, Charleston, WV, USA; 4Department of Anesthesiology and Perioperative Medicine, Rutgers Robert Wood Johnson, New Brunswick, NJ, USA; 5Anesthesiology, the Ohio State University Wexner Medical Center, Columbus, OH, USA; 6Department of Orthopedic Surgery, University of Maryland School of Medicine, Baltimore, MD, USA; 7Department of Anesthesiology, University of Maryland School of Medicine, Baltimore, MD, USA; 8Department of Anesthesiology, University of Pittsburgh Medical Center, Williamsport, PA, USA; 9Pain Medicine, MVM Health, East Stroudsburg, PA, USA; 10Anesthesiology and Pain Medicine, Mayo Clinic, Phoenix, AZ, USA; 11Interventional Pain Management, Napa Valley Orthopaedic Medical Group, Napa, CA, USA; 12Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN, USA; 13Department of Rehabilitation &amp; Regenerative Medicine, New York Presbyterian &ndash; Columbia &amp; Cornell, New York, NY, USA; 14Director of Clinical Research, Boomerang Healthcare, Walnut Creek, CA, USA; 15Neurosurgery, University of California Los Angeles, Los Angeles, CA, USA; 16Neuroradiology &amp; Pain Solutions of Oklahoma, Edmond, OK, USA; 17The Spine Center of SE Georgia, Brunswick, GA, USA; 18Anesthesiology, University of Wisconsin, Madison, WI, USACorrespondence: Dawood Sayed, Anesthesiology and Pain Medicine, The University of Kansas Medical Center, Kansas City, KS, USA, Tel +1 785-550-5800, Email [email protected]

A Systematic Guideline by the ASPN Workgroup on the Evidence, Education, and Treatment Algorithm for Painful Diabetic Neuropathy: SWEET

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