Trial Information

Spinal Cord Stimulation with Precision® SCS System versus Reoperation for Failed Back Surgery Syndrome

The purpose of this study is to compare the treatment- and cost-effectiveness of spinal cord stimulation versus reoperation for patients with Failed Back Surgery Syndrome.

Inclusion Criteria

Primary pain type - neuropathic with concordant radicular or neurological findings
Chief complaint of persistent or recurrent radicular leg pain, with or without low back pain, or equal distribution of leg and axial low back pain (e.g., 50% leg pain and 50% low back pain) after one or more lumbosacral surgical procedures (no upper limit)
MRI or CT myelogram of the lumbar and thoracic spine (within 12 months prior to screening) rules out a pathology that might compromise SCS electrode placement or pathology in addition to neural compression that might contribute to the subject’s pain
All study candidates must pass study site’s routine psychological/psychiatric evaluation for SCS before randomization to SCS or reoperation

Exclusion Criteria

Chief complaint of low back pain (greater than 50%)
Pain in a new distribution following the most recent lumbosacral surgical procedure (i.e., pain in an area substantially different from the location of pain that the most recent procedure was expected to relieve)
Radiographic evidence of frank instability (grossly mobile spondylolisthesis or abnormal subluxation) requiring fusion, calcific arachnoiditis, or severe thoracic stenosis
Radiographically demonstrated (by myelographic block or its MRI equivalent) critical cauda equina compression
A disabling or potentially disabling neurologic deficit (e.g., foot drop, neurogenic bladder) in the distribution of a nerve root or roots caused by surgically remediable compression

Jessica Short, Clinical Research Coordinator
Millennium Pain Center
1015 S Mercer Ave.
Bloomington, IL 61701
Phone: 309-662-4321
Fax: 309-661-4815
Email: jshort@millenniumpaincenter.com

View Map

Research Center Information: Millennium Pain Center

If you would like to learn more about participating in this study, please send an email message using the form below.

Name:
Address:
City:
State:
Country:
Phone:
Email:
Message:

DISCLAIMER: This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.