A Phase 4 interventional study of Perc-DLR/Perc-DLG and Fluoroscopy guided transforaminal epidural steroid injection (TFESI) in Radicular Pain, sponsored by ArthroCare Corporation. Completed at 13 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-08-26.
Sponsored by ArthroCare Corporation · Phase 4, Interventional, and Treatment
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:
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.
ArthroCare Corporation is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Fluoroscopy guided transforaminal epidural steroid injection (TFESI)
Drug: Fluoroscopy guided transforaminal epidural steroid injection (TFESI)
Percutaneous Disc Decompression of the lumbar level which is secondary to radicular pain
Device: Perc-DLR/Perc-DLG
Device technique will be used per IFU
Also known as: Percutaneous Disc Decompression
Injection of steroid solution into the lumbar level
Also known as: TFESI
Pain status change assessed using a visual analogue scale (VAS) for radicular pain intensity.
Time frame: 6 weeks, 3 mos., 6 mos., 1 year, 2 years
Functional status change evaluated using the Oswestry Disability Questionnaire.
Time frame: 6 weeks, 3 mos., 6 mos., 1 year, 2 years
General health status change determined using the SF-36.
Time frame: 6 weeks, 3 mos., 6 mos., 1 year, 2 years
Employment status change examined using a questionnaire developed by the American Academy of Orthopaedic Surgeons (AAOS) and the North American Spine Society (NASS).
Time frame: 6 weeks, 3 mos., 6 mos., 1 year, 2 years
Subject global satisfaction post-procedure assessed using a global satisfaction statement.
Time frame: 6 weeks, 3 mos., 6 mos., 1 year, 2 years
Change in frequency and type of pain medication use.
Time frame: 6 weeks, 3 mos., 6 mos., 1 year, 2 years
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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ArthroCare Corporation