Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT00300898 |
Other study ID # |
IRB 8006 |
Secondary ID |
|
Status |
Withdrawn |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 2006 |
Est. completion date |
August 2007 |
Study information
Verified date |
May 2022 |
Source |
The Cleveland Clinic |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to learn which of three minimally invasive procedures is the
most effective for treatment of contained lumbar disc herniation.
Description:
Contained herniation of the lumbar intervertebral disc is a frequent cause of leg and back
pain. Over the last decade, there is a tendency to shift from surgical treatment of the
intervertebral disc including laminectomy/discectomy to an excess of nonoperative management.
Three techniques introduced recently are used as minimally invasive treatments for
decompression of contained herniation of the nucleus pulposus. Nucleoplasty uses Coblation®
radiofrequency vaporization of nuclear tissue to decompress the intervertebral disc. Catheter
disc decompression uses heat from a resistive coil positioned in the area of disc herniation
while Dekompressor® uses volume reduction to decrease an intradiscal pressure.
This is a comparison study which investigates if intervertebral electrothermal disc
decompression produces better pain relief measured on VAS scale, improvement in functional
capacity, return to work and opioid use, than nucleoplasty or percutaneous disc decompression
(Dekompressor) of the lumbar intervertebral disc in a prospective randomized controlled
study. Patients will be randomized into four treatment groups in equal numbers. The first
group will be treated using nucleoplasty, the second will receive Dekompressor® lumbar disc
decompression, the third will receive thermal treatment using decompression catheter
(Achutherm TM) and the forth will be the control group. The control group will be treated
conservatively using medications including gabapentin, a breakthrough opioid (oxycodone 5 mg
1-2 tablets q 4-6 hours as needed), NSAID, epidural steroid injections and physical therapy.
Patients will be followed and assessed at one, three, six, nine and twelve months following
the procedure using VAS scores, Oswestry and SF-36 Short Form questionnaires, opioid use and
return to work evaluation.