Spine surgeons face a difficult choice when their patients continue to suffer low back pain despite a successful spine surgery: reoperation or spinal cord stimulation?
To help spine surgeons answer this question with greater certainty, the National Spine Network (NSN) has embarked on a prospective, randomized, multi-center clinical trial comparing the outcomes of spinal cord stimulation with repeat spine surgery for patients suffering from Failed Back Surgery Syndrome (FBSS).
The study begins enrolling patients this month and is sponsored by Medtronic.Approximately 200,000 Americans annually undergo an initial spine surgery for the treatment of chronic low back pain, according to a 1998 survey of spine surgeons commissioned by Medtronic.
The same research indicates that about 25 percent of these patients continue to experience unresolved pain after surgery. And, despite a second procedure to relieve the pain, more than 13,000 patients still suffer from unresolved pain. Spinal cord stimulation and spine surgery can significantly reduce chronic low back pain of neuropathic etiology. “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,” said Bruce Fredrickson, M.D., an orthopedic surgeon specializing in spine procedures at the SUNY Upstate Medical University in Syracuse, N.Y. and the principal investigator for the study.
“For the first time, we are undertaking research of sufficient scope to predict which patients are most likely to benefit from additional surgery and which patients are better candidates for 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.
“The National Spine Network advocates an interdisciplinary approach to the treatment of spine disorders, including chronic low back pain,” said Harry Freedman, executive director of NSN, an association of the country’s leading comprehensive spine centers.
“Our involvement in this study demonstrates the NSN’s commitment to improve the cost-effectiveness, consistency and quality of spine care.”Eleven NSN members are participating in the study: Washington University Medical Center in St. Louis, Mo.; Emory Spine Center in Decatur, Ga.; Hospital for Joint Diseases in New York; Hospital for Special Surgery in New York; Nebraska Spine Center in Omaha; Swedish Medical Center – Providence Campus in Seattle; Rush Presbyterian-St.Luke’s Medical Center in Chicago; SUNY Upstate Medical Center in Syracuse, N.Y.; Texas Back Institute in Plano; University Hospitals of Cleveland in Ohio; University of Iowa Medical Center in Iowa City.The study calls for the enrollment of 150 patients by early 2003. Once enrolled, each patient will be followed for 24 months with follow-ups at three, six, 12, 18 and 24 months.
Spinal cord stimulation and spine surgery can significantly reduce chronic low back pain of neuropathic etiology. Spinal cord stimulation works by blocking pain signals from reaching the brain, where they would be perceived as pain. Spine surgery works by either decompressing pinched nerves that cause pain or connecting two or more bones in the spine.As with any treatment, side effects can occur.
Because spinal cord stimulation systems are surgically placed, infections are possible. Potential complications from spinal cord stimulation may include undesirable changes in stimulation, lead migration and loss of pain-relieving effects in some patients. Risks of surgery include excessive bleeding and an adverse reaction to anesthesia. Since spine surgery involves the nervous system, nerve damage is another risk. Both spinal cord stimulation and reoperation are standard medical procedures used to treat chronic pain.
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