I’m honored to collaborate with Dr.Lutz to help patients worldwide who suffer with neck and low back pain. Because we recognize that most back pain is caused by these disc tears, we are studying this unique disc healing treatment, and are sharing our insights with other Spine Specialists worldwide
NEW YORK (PRWEB) March 12, 2018
Doctors Gregory Lutz, MD and Kevin Pauza, MD have launched a new medical research study to advance a minimally invasive medical procedure that could be the key to relieving lower back pain. This new study will be evaluating the ability of the Discseel™ treatment to restore and regrow damaged discs in the spine, caused by degenerative and bulging discs in the lower back. This highly anticipated study is expected to demonstrate the success of the procedure, which is the first treatment of its kind meant to replace many of the invasive spinal fusion procedures being performed. The treatment is the first and only one of its kind to use an FDA-approved biologic to seal and regrow degenerated discs.
The expected findings of this study may help back pain sufferers avoid unnecessary invasive surgery. Another benefit of the results of the study may be the impact on addressing the global opioid addiction, leading to a massive health care crisis in the United States. According to Doctor Richard Deyo, Professor of Medicine at Oregon Health & Science University, the opioid epidemic in the US can be linked, in part, to the over 200% increase in spinal fusion surgeries and the 76% of fusion patients who continue to use opioids long after their fusion surgery. Interestingly, the number of those individuals suffering from chronic low back pain has remained nearly unchanged.
According to the American Chiropractic Association, lower back pain is believed to be the number one cause of disability in the world, and is experienced by approximately 80% of adults at least once in their lifetime. Lower back pain is one of the highest costing medical problems in the United States, topping out at over $600 billion annually.
Degenerated discs cause a high percentage of chronic lower back pain, and non-healing disc tears result in degenerated discs. Although lower back pain may improve on its own, only 3% of bulging discs heal on their own.
The goal of the study is to determine whether the naturally-occurring tissue sealant known as fibrin, whether used alone or with the addition of a subject’s own cells and growth factors, will repair damaged discs, reduce pain and improve function when injected into a pain-causing disc. Injected fibrin acts as a sealant, creating a physical barrier between the disc’s center gel, which is the source of inflammation on the spine’s pain nerves. In this logical treatment, fibrin seals the discs and then provides a scaffold for the growth-factors and other healing constituents found in the patient’s own Platelet Rich Plasma (PRP). Dr. Pauza’s work was called: “A breakthrough” by the European Neurosurgical Society. Fibrin first seals the disc, and then is placed into the sealed disc (PRP contains growth factors and other components that stimulate and allow for disc cell regrowth in the damaged disc, eliminating the pain being caused by inflammation of the spinal nerves).
This new treatment has demonstrated excellent results both early on and at 10 year follow-ups, and remains the only treatment specifically meant to seal and heal disc tears. In recent years, biologics, including growth factors from a patient's own stem cells being injected into their discs, have become an increasingly popular form of treatment, but it is certain that fibrin is first necessary to seal the leaky discs.
In 2016, Gregory Lutz, MD, Physiatrist-in-Chief Emeritus at Hospital for Special Surgery (HSS) in Manhattan and Professor of Clinical Rehabilitation Medicine at Weill Medical College of Cornell University, published promising data from a double-blind, randomized controlled study that supported the safety and efficacy of intradiscal PRP therapy as a first-line treatment for degenerative disc disease.
At the same time, Kevin Pauza MD, Founding Partner of Texas Spine and Joint Hospital Baylor, led twenty research sites, evaluating a natural disc sealing process he invented. These sites addressed degenerative disc tears that prevented other biologics from remaining in the discs after injection. Pauza’s early work was awarded the North American Spine Society Outstanding Study of the Year.
This new study, lead by Lutz and Pauza, combines the best aspects of their early discoveries into a single treatment with the potential of helping countless patients who've already undergone spine surgery without experiencing relief, and those who have been suffering from lower back pain, avoid spine surgery. It’s the first randomized study of its kind.
Study subjects are expected to participate in the prospective, randomized, blinded and controlled study over a period of two years. Scientists privy to the Discseel™ interim analysis data are optimistic, and leaders voice optimism in recognizing the potential benefits to patients without other reasonable treatment options.