Home » Clinical Trials » Therapeutic Areas
Therapeutic Areas: Musculoskeletal | Neurology | Family Medicine | Orthopedics/Orthopedic Surgery
Disease Category: Lower Back Pain
Location: United States, IL
A Prospective, Randomized, Multi-Center, Open-Label Clinical Trial Comparing Disc Biacuplasty with Medical Management for Discogenic Low Back Pain
The primary objective of this protocol is to evaluate the safety and efficacy of the TDS in treating discogenic pain of the lumbar spine using a modified temperature profile disc biacuplasty procedure. The primary efficacy measure will be the Visual Analog Scale (VAS) at 6 months. Safety will be evaluated through collection and review of reported Adverse Events (AEs).
Patient Inclusion Criteria:
- Stabilized on pain medication regimen regimen for >2 months
- History of chronic low back back (greater than 6 months) unresponsive to non-operative care
- Back pain more prominent than leg pain which is commonly exacerbated by flexion or bending or prolonged sitting.
Patient Exclusion Criteria:
- Evidence of compression radiculopathy with predominant leg pain
- Evidence of greater than 2 discs dessicated based on MRI or symptomatic involvement of more than one lumbar disc level.
- Asymptomatic disc bulges >5mm at the treatment level.
- Prior lumbar surgery of any kind at lumbar level or prior fusion below T10.
- Any generalized pain or multifocal pain, conversion or multiple non-anatomical complaints.
Jessica Lowe, Clinical Research Coordinator
Millennium Pain Center
1015 S Mercer Avenue
Bloomington, IL 61701
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.
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