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Neurological Surgery, P.C. Offers “Sense™” Clinical Trial For Severe, Chronic Low Back And Leg Pain

Only Site on Long Island to Study Combination of Neurostimulation Therapies for Patients with Failed Back Surgery Syndrome

ROCKVILLE CENTRE, NY – Neurological Surgery, P.C. (NSPC) is the only site on Long Island participating in the national SENSE™ (Subcutaneous and Epidural Neuromodulation System Evaluation) clinical trial of implantable neuromodulation systems for the treatment of chronic low back and leg pain due to Failed Back Surgery Syndrome.  The NSPC arm of the study is led by fellowship-trained functional and restorative neurosurgeon Brian J. Snyder, M.D., who has extensive experience implanting neuromodulation devices to treat chronic pain.

The study will evaluate the combination of two types of neuromodulation approaches – peripheral nerve field stimulation (PNfS) and spinal cord stimulation (SCS) –­- to determine whether combining the two therapies provides more relief from chronic low back and leg pain than SCS alone.  PNfS and SCS are minimally invasive neurostimulation therapies that involve implantation of a stimulation device and small electrical leads.  In SCS, leads are placed in the epidural space (space in the outermost part of the spinal canal) to interrupt or mask the transmission of pain signals to the brain.  In PNfS, leads are placed under the skin (in the subcutaneous tissue) to stimulate the network of peripheral nerve fibers in the area where pain is most severe.

“Patients are often referred to me after repeated spine surgeries fail to relieve their low back and leg pain and they have tried multiple nonsurgical treatments,” said Dr. Snyder, who also serves as Director of Functional and Restorative Neurosurgery at Winthrop-University Hospital.  “Both of the therapies in the SENSE study have the potential to offer pain relief when spine surgery does not help.  With this study, we will be able to get reliable data on whether the therapies should be combined for some patients.” Failed Back Surgery Syndrome is a condition in which patients continue to have low back and leg pain following lumbar spine surgery. The SENSE study is a large randomized, prospective, multicenter clinical trial to demonstrate the efficacy and safety of PNfS combined with SCS to manage low back and leg pain.  The study will look at pain reduction, quality of life and changes in disability.  Patients will be randomly assigned to either an SCS-only group, or a group that receives both SCS and PNfS.  SENSE is sponsored by St. Jude Medical, a manufacturer of neuromodulation systems.

Study participants must be at least 22 years old; have chronic low back or leg pain secondary to Failed Back Surgery Syndrome; have an average pain score of “6” or higher on a scale of 1-10; have attempted “best” medical therapy, and have tried and failed at least three medically supervised treatments including, but not limited to, physical therapy, acupuncture, injections, nerve blocks, chiropractic, psychotherapy, biofeedback and other therapies; and failed treatment with medications from two or more classes of drugs.  Individuals who were previously implanted with a neuromodulation system are not eligible for the study.

In a statement, Dr. Mark D. Carlson, Chief Medical Officer and Vice President of Global Clinical Affairs for St. Jude Medical, said:  “Traditional spinal cord stimulation therapy has been used to manage chronic pain for more than 40 years and it works very well for many pain conditions.  Peripheral nerve field stimulation as an adjunct therapy has the potential to improve outcomes for those who struggle with severe chronic low back and leg pain.”

For more information, please call Dr. Snyder’s office at (516) 442-2250.

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