Radicular Pain Clinical Trial
Official title:
Prospective, Randomized, Multi-center Clinical Study of Plasma Disc Decompression Efficacy
The goal of this post-marketing surveillance study is to compare two procedures which are
used to treat patients who require a disc decompression procedure. These procedures are: 1)
plasma disc decompression procedure using Coblation technology and 2) fluoroscopy guided
transforaminal epidural steroid injection (TFESI). The study will evaluate treatment
efficacy and rate of improvement in symptoms through the first six months following the
procedure.
The principal objectives of this study are to determine whether subjects receiving the
plasma disc decompression procedure demonstrate:
1. Improved clinical outcomes over subjects receiving TFESI
2. More rapid reversal of symptoms than subjects receiving TFESI
Chronic leg and back pain are two of the most common ailments in our society, and are
associated with serious financial and social consequences. One surgical treatment modality
is plasma disc decompression, based on the principle that inducing a small reduction of
volume in the closed hydraulic space of an intact (contained herniated) disc can relieve
pressure, and thereby reduce or eliminate pain. Another widely accepted treatment is
transforaminal epidural steroid injection (TFESI), which delivers a high concentration of
corticosteroid to the targeted disc nerve interface, and is thought to decrease pain by
reducing inflammation.
This study proposes to compare the efficacy of the plasma disc decompression procedure to
the standard TFESI series in patients who have failed to improve after an initial TFESI
injection. The goal is to better understand the differences between these two treatment
modalities and to monitor the 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 plasma disc decompression procedure after failing one
fluoroscopy guided TFESI. Patients will continue to be monitored over the 2-year
post-procedure period to assess stability of treatment effect.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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