Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00373724
Status:
COMPLETED
Last Update Posted:
2008-05-09
First Post:
2006-09-07
Brief Title:
A Placebo-Controlled Study Assessing Lateral Branch Radiofrequency Denervation for Sacroiliac SI Joint Pain
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-05
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:
In order to determine whether L4 and L5 primary dorsal rami and S1-3 lateral branch radiofrequency denervation is effective for sacroiliac SI joint pain we are conducting a randomized controlled study
Detailed Description:
30 subjects with SI joint pain confirmed by SI joint injections will be randomized to receive either L4 and L5 primary dorsal rami and S1-3 lateral branch radiofrequency denervation or sham denervation To facilitate patient blinding in both groups 1 ml of lidocaine will be injected before true or sham denervation so patients cannot feel heating The stimulation will be the same for both groups and blinding assessed after the procedure Follow-up visits will be at 13 and 6-months postprocedure
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