International Medical Advisory Board
Since its inception, Axiom Worldwide’s DRX9000™ has shown promising anecdotal results in treating back pain caused by herniated discs, degenerative disc disease, sciatica, and facet syndrome. In response to these encouraging results, Axiom Worldwide established an International Medical Advisory Board in April 2006 to provide guidance on Axiom’s current and emerging technologies and their application in treating back pain. In addition, the International Medical Advisory Board is instrumental in developing and implementing short and long term clinical trials.
Even though anecdotal evidence continued to show promising results in treating back pain with the DRX9000™, in 2006 our International Medical Advisory Board concluded that the current available data in the peer-reviewed literature was too limited to determine conclusively whether non-surgical spinal decompression provided benefits to individuals with low back pain over other non-surgical treatments. Previous studies utilized inconsistent methodologies and less than adequate study designs that included inconsistent sample sizes, differing clinical patient inclusion criteria, different protocol lengths, and poor post-therapy follow-up. In addition, investigators did not always use appropriate endpoint measures and sometimes used poor outcome markers. Previous studies also reported negative results inadequately and neglected to include placebo controls. “A Systematic Literature Review of Spinal Decompression Via Motorized Traction for Low Back Pain” was authored by two members of the International Medical Advisory Board and published in the September 2006 issue of Pain Practice.
International Medical Advisory Board Members
Joseph Pergolizzi, Jr., MD CHAIRMAN
Joseph Pergolizzi, Jr., MD is an Adjunct Assistant Professor in the Department of Medicine at Johns Hopkins University School of Medicine, and a senior partner in the Naples Anesthesia and Pain Associates Group of South West Florida. Dr. Pergolizzi holds a BS in Physical Chemistry from St. Johns University, an M.D. with highest honors from Ross University School of Medicine, completed his residency in Anesthesia at Georgetown University School of Medicine, and a clinical research fellowship in the Department of Medicine at Johns Hopkins University School of Medicine.
Dr. Pergolizzi has over 100 scientific papers and projects either presented or published. He is an internationally recognized expert in Pain Medicine, Anesthesia, Internal Medicine, Clinical Research and Drug Discovery. Dr. Pergolizzi is the Editor in Chief of the Clinical Researcher, Editor for The International Journal of Pain Medicine and Palliative Care, Editor for The Scientific World Journal of Anesthesia, Editor for International Journal of Nanomedicine, and an invited feature editor for Pain Medicine. Dr. Pergolizzi serves on the Board of Directors for the Coalition for Pain Education (COPE), is Co-Founder of the International Pain Research and Treatment Foundation, and a member of the Board of Directors of the National Institute of Pain. He is a faculty member of The Primary Care Institute’s pain medicine educational initiative, and Chairman of the Working Group in Pain Medicine (an international multi-disciplinary consortium of pain medicine experts).
Christian C. Apfel, MD, Ph.D.
Christian C. Apfel, M.D., Ph.D. is an Associate Professor of Anesthesia and Perioperative Care at the University of California at San Francisco. He earned his medical degree from the University of Giessen, Germany, School of Medicine and his Ph.D. in Medical Sciences from the University of Giessen, Germany. He completed a Clinical Research Fellowship and a Clinical ICU Fellowship at the University of Wuerzburg. He held faculty positions at the University of Wuerzburg and the University of Louisville, Kentucky before he was recruited to build up and lead the Perioperative Clinical Research Core at UCSF.
He has authored or coauthored numerous original articles, reviews, abstracts and other publications. His research is highly regarded throughout the world as reflected by being invited to give refresher course lectures for all major anesthesia societies.
Martin Auster, MD, MBA
Martin Auster, MD, is an Assistant Professor for the Department of Radiology at The Johns Hopkins University School of Medicine and Attending Radiologist, Vascular/Interventional Radiology at Johns Hopkins Bayview Medical Center in Baltimore, Maryland. Dr. Auster earned his medical degree at Drexel University College of Medicine (formerly Hahnemann Medical College), Philadelphia, PA and obtained his MBA in Medical Management Sciences from The Johns Hopkins University School of Professional Studies in Business and Education. He is currently a member of the Credentials Committee, at Johns Hopkins Bayview Medical Center, Section Chief, Interventional Radiology, Johns Hopkins Bayview Medical Center and Medical Director, Johns Hopkins White Marsh Outpatient Radiology Office.
John Bruce Leslie, MD, MBA
John Leslie, MD, is Professor of Anesthesiology of Mayo Clinic College of Medicine, Rochester, MN, but spends his time at the Arizona facility where he is a Consultant in Anesthesiology at Mayo Clinic Hospital. Dr Leslie received his undergraduate education at Johns Hopkins University, medical training at Duke University Medical School, and his residency and fellowship training at Duke University Medical Center. Dr. Leslie specialized in cardiothoracic anesthesia and spent an additional year in clinical pharmacology and drug development studies. While serving as Medical Director of Perioperative Services for Mayo Clinic Hospital, Dr. Leslie obtained an MBA specializing in Healthcare Management.
Dr. Leslie practices all aspects of clinical anesthesia, resident training, and is actively engaged in clinical research in several areas. His areas of research interest have included new drug development, antiemetics, opioids, TIVA, antihypertensives, anesthetics, computers in medicine, adult education, CAM, postoperative ileus, acute pain, and chronic low back pain. Dr. Leslie also serves on numerous departmental, institutional, national anesthesiology and national pharmaceutical industry association councils.
Alex Macario, MD, MBA
Alex Macario, MD, is Professor of Anesthesiology and, by courtesy, of Health Research and Policy at the Stanford University School of Medicine. He completed his undergraduate, medical school, and business school training at the University of Rochester. He trained in anesthesiology at Stanford University and was chief resident. He then completed a fellowship in health services research. Dr. Macario has completed internationally recognized studies on the management of the operating room suite, as well as pioneering work on the cost-effectiveness of drugs and devices. He is director of a Fellowship in the Management of Perioperative Services, a postgraduate fellowship program which trains one to two physicians per year in leadership, entrepreneurship, and management science with special attention to the delivery of surgical care.
Charlotte Richmond, PhD
Charlotte Richmond, PhD, is the Director of Clinical Research for NEMA Research, Inc. and the CEO of Biomedical Research and Education Foundation. She is the chairperson of NEMA Research Institutional Review Board (IRB) and a member of the IRB and the Animal Care Research Committees at Mount Sinai Medical Center in Miami Beach, FL.
Dr. Richmond obtained her PhD from the Graduate School of Biomedical Sciences at the University of Texas Health Science Center at San Antonio. She received her Bachelor of Science and Master of Science Degrees in Nursing from California State University, Fresno. Prior to working with NEMA Research, Inc., Dr. Richmond was the Director of Anesthesia Research at Mount Sinai Medical Center in Miami Beach, FL. Dr. Richmond specializes in developing and implementing clinical trial protocols and the creation of supporting research documents. She has conducted clinical trials for numerous pharmaceutical and investigational device companies. Dr. Richmond has presented her research at local, state, national and international conferences.
Advisory Board Members
Tong J. Gan, MBBS, FRCA, FFARCSI
T.J. Gan is Professor of Anesthesiology at Duke University Medical Center. He earned his medical degree from The London Hospital Medical College, University of London. Dr. Gan is a member of American Society of Anesthesiologists, International Anesthesia Research Society, Society of Ambulatory Anesthesia, Anesthetic Research Society United Kingdom and American University of Anesthesiologists, and International Society of Anesthetic Pharmacology. He is currently on the Board of Directors for International Society of Anesthetic Pharmacology and Society of Ambulatory Anesthesia. He is also on several committees for the American Society of Anesthesiologists and for the Society of Ambulatory Anesthesia.
Richard M. Langford, MD
Richard M. Langford, MD is currently a Consultant in Anesthesia and Pain Medicine, St. Bartholomew’s Hospital, Barts and The London NHS Trust. He received his medical degree from The Middlesex Hospital Medical School, University of London. He is currently Director of Academic Anesthesia, Pain medicine and Critical Care Centre, William Harvey Research Institute, St. Bartholomew’s and The Royal London Hospitals Medical School, Queen Mary College, University of London; Visiting Professor, City University, London; Director, Anesthetic Laboratory (Clinical Measurement Service), St. Bartholomew’s Hospital; Clinical Director, Joint Clinical Research Centre, Barts and The London NHS Trust / Queen Mary College; Deputy Director, Research and Development, Barts and The London NHS Trust. He is also an Associate Editor (Europe) International Journal of Acute Pain.
Charles Edward Laurito, MD
Charles E. Laurito, MD is Professor of Anesthesiology and of Anatomy & Cell Biology in the College of Medicine at the University of Illinois at Chicago. He is certified in Pain Medicine by the American Board of Anesthesiologists and much of his clinical work is devoted to providing relief for patients suffering from acute, chronic, and cancer related pain. His areas of research have focused on basic understandings of how noxious stimuli are perceived as being painful: what neurotransmitters are released at the spinal cord level. He has worked to develop methods to provide pain relief by blocking these molecules at their release site and by adding opioids specifically where needed. Dr. Laurito has served on the Faculty Senate, Committee on Student Promotions, Committee on Clinical and Adjunct Appointments and Promotions, and on the Medical Staff Executive Committee. He is an Editor of the Journal of Clinical Anesthesia and of The International Journal of Pain Medicine and Palliative Care and a Reviewer for several journals focusing on Pain Management and Anesthesiology. He helps to develop the Anesthesia Knowledge Test for residents nationwide and is a Senior Oral Examiner for the American Board of Anesthesiology.
Mark Thomas Matsunaga, MD
Dr. Mark Matsunaga did his undergraduate work at University of California at Santa Barbara, his medical school training at George Washington University Medical School, and his Anesthesiology residency at the University of Maryland. He is double-boarded in Anesthesiology and in Pain Medicine. He is currently the Director of the Comprehensive Pain Center in Howard County, Maryland. This center assists patients with the diagnosis, treatment and management of their pain issues in a multidisciplinary coordinated setting.
Spencer Serras, MD
Spencer Serras, MD is currently the Attending Neuroradiologist at Staten Island University Hospital in Staten Island, New York. Dr. Serras completed his fellowship in Neuroradiology at Montefiore Medical Center, Albert Einstein College of Medicine in Bronx, New York. He received his undergraduate and post Baccalaureate from The City College of New York and his medical degree from Ross University School of Medicine in Dominica, West Indies. He is associated with the American Society of Neuroradiology, The Radiological Society of North America and the American College of Radiology.
Steering Committee Consensus Statement
Axiom Worldwide’s International Medical Advisory Board is tasked with providing guidance on Axiom’s current and emerging technologies and their application in treating chronic back pain. In addition, the International Medical Advisory Board is further tasked with developing and implementing short and long term clinical trials to validate the safety and efficacy of products utilizing the Axiom Protocols. The goal is to augment the current understanding of how to best treat chronic back pain and determine how the Axiom Protocols should be used in everyday practice for these patients.
Retrospective data and the more recent Pilot Study data are very encouraging in favor of the DRX9000™ . A retrospective review of 94 patients treated on the DRX9000™ revealed a reduction in mean low back pain score from 5.99, on a 0 to 10 scale, at initial presentation to 0.87 after the last DRX™ treatment. Patients also appeared to have improved function while requiring fewer analgesics after completion of treatment. This study has been accepted for publication in Pain Practice.
In a recent prospective Pilot Study of 18 evaluable subjects with a mean ten year history of chronic low back pain, 89% of the patients experienced a clinically and statistically significant reduction of pain greater than 50%. These treatment effects are large when compared to many drug trials and even some types of surgery.
In Nov 2006 the Journal of the American Medical Association published the results from the Spine Patient Outcomes Research Trial (SPORT). This National Institutes of Health (NIH) funded study measured surgical versus non-surgical treatment of lumbar disc herniation in patients with radiculopathy for at least six weeks. The authors reported, "Patients in both the surgery and nonoperative treatment groups improved substantially over the first 2 years. Between-group differences in improvements were consistently in favor of surgery for all outcomes and at all time periods but were small..."
Compared to this first SPORT study, the effectiveness of the DRX9000™ , as demonstrated in the Pilot Study, and currently being tested in a multi-center prospective trial of the DRX9000™ , is noteworthy. Plans for a randomized clinical trial with the DRX9000™ will follow this current prospective trial and will help to further define the role of the DRX9000™ in the treatment of chronic low back pain.
With a safe non-invasive intervention like the DRX9000™ and with the known effect of greater than 50% reduction in chronic low back pain following DRX9000™ treatment, Axiom Worldwide’s International Medical Advisory Board believes the Axiom Protocols and Non-Surgical Spinal Decompression via the DRX9000™ should be made routinely available to appropriate patients suffering with chronic low back pain.
As a group we look forward to our continued study of the DRX9000™ and the Axiom Protocols.
