Funding Agency:

ArthroCare Corporation

Total Project Period:

11/30/04 - 9/5/08

Total Project Award:

$50,612

Principal Investigator:

Peter C. Gerszten, MD, MPH

Co-Investigator:

William Welch, MD (The Pennsylvania Hospital, University of Pennsylvania)

Project Summary:

Percutaneous disc decompression is based on the principle that inducing a small reduction of volume in a closed hydraulic space, such as an intact (contained herniated) disc, can promote significant relief of pressure, and therefore reduce or eliminate pain. Once intradiscal pressure is relieved, the disc is believed to down-regulate inflammatory mediators, reduce in size, and initiate a healing process, thereby alleviating chemical, mechanical, and neural genesis of discogenic pain.

DISC Nucleoplasty was introduced clinically in July of 2000 as a minimally invasive alternative for performing PDD using Coblation technology. The DISC Nucleoplasty procedure is conducted using a bipolar radiofrequency-based device (PercDLE™ SpineWand™, ArthroCare Corp, Sunnyvale, CA), which achieves precise tissue removal using a focused plasma process. The energized particles in the plasma have sufficient energy to break molecular bonds, excising or dissolving soft tissue at relatively low temperatures (typically 40°C to 70°C), thereby preserving the integrity of surrounding healthy tissue. The treatment approach is similar to that used to perform discography, an already existing and common technique. The PercDLE SpineWand (DISC Nucleoplasty device) is U.S. FDA (Food and Drug Administration) cleared for ablation, coagulation, and decompression of disc material (nucleus pulposus) to treat symptomatic patients with contained herniated discs. The DISC Nucleoplasty procedure relieves pain by decreasing intradiscal pressure through the ablation of nucleus pulposus, with the end result of eliminating disc protrusion and the associated compression of the nerve root.

This study proposes to compare the efficacy of the DISC Nucleoplasty procedure to the standard and usual selective nerve root injection (SNRI) series in a patient population who have failed to improve after an initial SNRI injection. Only patients who have failed an initial SNRI or epidural steroid injection (ESI) will be enrolled in the study. The goal of this study is to better understand the differences between the treatment efficacies and rates of symptom improvement through the first six months between patients receiving a series of at least two selective nerve root injections and those undergoing the one-time DISC Nucleoplasty procedure after failing one SNRI or ESI. In addition, patients will continue to be monitored over the 2-year post-procedure period to assess stability of treatment effect.