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SUNY Upstate participates in national back pain clinical trial

Study examines two common treatments for chronic lower back pain: spinal cord stimulation or reoperation

SUNY Upstate Medical University is currently enrolling patients in a prospective, randomized, clinical trial comparing the outcomes of spinal cord stimulation with repeat spine surgery for patients suffering from Failed Back Surgery Syndrome (FBSS). The trial is being conducted under the auspices of the National Spine Network (NSN) and is sponsored by Medtronic.

The national study's principal investigator is Bruce Fredrickson, M.D., an orthopedic surgeon specializing in spine procedures at the SUNY Upstate Medical University. "This landmark NSN study promises to yield the data we need to make the best treatment recommendations for patients with low back pain that remains unresolved after a successful spine surgery," he said. "For the first time, we are undertaking research of sufficient scope to help determine which therapy patients are most likely to benefit from, surgery or spinal cord stimulation."

The study also seeks to determine which treatment option — spinal cord stimulation or repeat spine surgery — provides reduced pain, greater functional status, improved quality of life and reduced disability to patients with unresolved low back pain.

Once enrolled in the study, subjects will be followed for 24 months with follow ups at three, six, 12, 18 and 24 months. The final results of the study are expected to be published by 2005. Candidates for the study must meet all entry criteria, including previous back surgery more than a year prior to enrollment, failure of alternative treatment measures such as medical or physical therapies, disabling pain that has limited their social and vocational activities, age 20 or older, no medical contraindication to surgery (including pregnancy) and clearance from a clinical psychiatrist if indicated.

Spinal cord stimulation and spine surgery may reduce chronic low back pain of neuropathic etiology. Spinal cord stimulation blocks pain signals from reaching the brain, where they would be perceived as pain. Spine surgery decompresses painful pinched nerves or connects two or more bones in the spine.

As with all surgical procedures, there are risks. Removal of soft tissue in the decompression surgery can cause further damage to the nerve roots. New scar tissue may form during the healing process that can lead to further compression of the nerve roots. In fusion surgery, the healing process takes three to six months, and the bones may not heal. In the case of spinal cord stimulation, infection can occur during the trial period, or during positioning of the wire lead. Surgical complications such as bleeding, blood clots, or paralysis can occur from the placement of the permanent wire lead. Possible repositioning of the wire lead, requiring a second surgery, may be required for optimum results. Stimulation does not benefit all patients. Either treatment is more likely than not to result in significant pain relief for individuals suffering from this condition.

Approximately 200,000 Americans undergo an initial spine surgery for the treatment of chronic low back pain each year. About 25 percent of these patients continue to experience unresolved pain after surgery. Despite a second procedure to relieve the pain, more than 13,000 patients still suffer from unresolved pain.

For more information on the study, call Health Connections at 315-464-8668.