Spinal cord stimulation vs. reoperation: Rush-Presbyterian-St. Luke's Medical Center

Orthopedic surgeons at Rush-Presbyterian-St. Luke's Medical Center in Chicago are conducting a clinical study to determine which treatment -- a second surgery or a spinal cord stimulator -- is most effective at helping relieve pain after low back surgery.

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, Inc., Minneapolis, Minn. 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 that originates in the brain. 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.

"This landmark 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 Dr. Gunnar Andersson, MD, chairperson, department of orthopedic surgery at Rush-Presbyterian-St. Luke's Medical Center.

Rush is the only Chicago medical center participating in the 11-site trial. "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 is supported and run by the National Spine Network, Marietta, Ga., and Medtronic, Inc. The NSN (www.NSNonline.org) is a non-profit organization comprised of 28 independent centers of excellence for spine care. 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 study seeks enrollment of a total of 150 patients across all 11 sites by early 2003. Once enrolled, each patient 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 have had 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.

People who think they or a family member may be eligible to enroll in this clinical trial can call (319) 335-8408 or visit www.NSNonline.org/FBSS for more information.

NSN announced the study at the American Academy of Orthopedic Surgeons (AAOS) meeting in San Francisco on March 1. Medtronic, Inc. (www.medtronic.com) is a leading medical technology company.

Rush-Presbyterian-St. Luke's Medical Center includes the 809-bed Presbyterian-St. Luke's Hospital; 154-bed Johnston R. Bowman Health Center for the Elderly; Rush University (Rush Medical College, College of Nursing, College of Health Sciences and Graduate College); and seven Rush Institutes providing diagnosis, treatment and research into leading health problems. The medical center is the tertiary hub of the Rush System for Health, a comprehensive healthcare system capable of serving about two million people through its outpatient facilities and five member hospitals.