Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00370799
Status:
COMPLETED
Last Update Posted:
2013-08-16
First Post:
2006-08-30
Brief Title:
Effectiveness of Caudal Epidural Injections in Treatment of Chronic Low Back and Lower Extremity Pain
Sponsor:
Pain Management Center of Paducah
Organization:
Pain Management Center of Paducah
Study Overview
Official Title:
A Randomized Prospective Double-Blind Controlled Evaluation of the Effectiveness of Caudal Epidural Injections in Lumbar Disc Herniations Spinal Stenosis Discogenic Pain and Post-Lumbar Laminectomy Syndrome
Status:
COMPLETED
Status Verified Date:
2013-08
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:
To demonstrate clinically significant improvements or lack thereof in the caudal epidural patients with our without steroids
To evaluate differences in outcomes in patients receiving steroids compared to those patients randomized to the local anesthetic group who did not receive steroids
To assess improvements among patients and compare steroid groups with each other and local anesthetic group
To evaluate and compare the adverse event profile in all patients
To evaluate differences in outcomes in patients receiving steroids compared to those patients randomized to the local anesthetic group who did not receive steroids
To assess improvements among patients and compare steroid groups with each other and local anesthetic group
To evaluate and compare the adverse event profile in all patients
Detailed Description:
Patients with chronic low back pain of at least 6 months duration non-responsive to conservative management with NSAIDS physical therapy or chiropractic treatment exercises
A single-center prospective controlled double blinded randomized study of patients in 4 groups
Group 1 local anesthetics only
Group 2 local anesthetic with 6mg of non-particulate Celestone
Group 3 local anesthetic with 6 mg of brand name Celestone
Group 4 local anesthetic with 40 mg of alcohol-free DepoMedrol
All patients will be unblinded in 12 months
Non-responsive patients will be unblinded after 3 months and will be crossed over to a different group
A single-center prospective controlled double blinded randomized study of patients in 4 groups
Group 1 local anesthetics only
Group 2 local anesthetic with 6mg of non-particulate Celestone
Group 3 local anesthetic with 6 mg of brand name Celestone
Group 4 local anesthetic with 40 mg of alcohol-free DepoMedrol
All patients will be unblinded in 12 months
Non-responsive patients will be unblinded after 3 months and will be crossed over to a different group
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