Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00300898
Status:
WITHDRAWN
Last Update Posted:
2022-05-03
First Post:
2006-03-08
Brief Title:
Radiofrequency Nucleoplasty vs Percutaneous Nucleotomy vs Decompression Catheter in Lumbar Disc Herniation
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Radiofrequency Nucleoplasty vs Percutaneous Nucleotomy Dekompressor vs Decompression Catheter for the Treatment of Painful Contained Lumbar Disc Herniation A Prospective Randomized Controlled Study
Status:
WITHDRAWN
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to enroll
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 laminectomydiscectomy 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None