Trial Information

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
Phone: 309-662-4321
Fax: 309-661-4815
Email: jlowe@millenniumpaincenter.com

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Research Center Information: Millennium Pain Center

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