Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00124774
Status:
COMPLETED
Last Update Posted:
2008-04-01
First Post:
2005-07-27
Brief Title:
Nucleoplasty for Contained Herniated Lumbar Discs
Sponsor:
Rijnstate Hospital
Organization:
Rijnstate Hospital
Study Overview
Official Title:
Nucleoplasty for Contained Herniated Lumbar Discs A Randomised Double Blind Prospective Comparison With Sham Treatment
Status:
COMPLETED
Status Verified Date:
2008-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective randomised double blind comparison trial Fifty patients will be included 25 in the nucleoplasty treatment group 25 in the control group The nucleoplasty group will undergo the nucleoplasty treatment Control group will undergo a sham treatment Both groups will undergo a standardised post-operative care program The study hypothesis is that nucleoplasty will lead to earlier pain reduction as compared with the sham treatment
Detailed Description:
This study will include patients with a contained lumbar hernia of at least 6 weeks existence in whom leg pain is the predominant complaint Standard treatment for these patients is conservative as an operation is not without risks and is not always effective Furthermore complaints will usually resolve in due time However the pain limits the patients in their daily activities often for a prolonged period
In this study nucleoplasty will be compared with a sham treatment and not with conservative treatment as the discography is thought to have some therapeutic effect
The primary outcome will be the proportion of patients with at least a 25 points decrease on a ten-point Jensen VAS score 3 months after treatment
In this study nucleoplasty will be compared with a sham treatment and not with conservative treatment as the discography is thought to have some therapeutic effect
The primary outcome will be the proportion of patients with at least a 25 points decrease on a ten-point Jensen VAS score 3 months after treatment
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