Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT01071369
Status:
COMPLETED
Last Update Posted:
2017-04-27
First Post:
2008-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Chronic Thoracic and Neck and Upper Extremity Pain
Sponsor:
Pain Management Center of Paducah
Organization:
Study Overview
Official Title:
A Randomized, Prospective, Double-Blind Controlled Evaluation of the Effectiveness of Cervical and Thoracic Interlaminar Epidural Injections in Thoracic and Cervical Disc Herniation, Discogenic Pain, and Post-Cervical Laminectomy Syndrome
Status:
COMPLETED
Status Verified Date:
2017-04
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 study improvements or lack thereof with the interlaminar epidural patients with or without steroids experiences mid back, upper back or neck pain with or without chest wall and upper extremity pain of at least 6-months duration non-responsive to conservative management.
Detailed Description:
This is a Single-center, prospective, controlled, double-blind, randomized study in thoracic and cervical regions.
Patients are studied in 2 groups in each region.
* Group I-local anesthetic only.
* Group II-local anesthetic with 6 mg of non-particulate Celestone.
All patients will be unblinded at 12 or 24 months. Non-responsive patients will be unblinded after 3 months and will be crossed over to a different group, if patient consents. Non-responsive patients may be unblinded and withdrawn from the study at any time.
Patients are studied in 2 groups in each region.
* Group I-local anesthetic only.
* Group II-local anesthetic with 6 mg of non-particulate Celestone.
All patients will be unblinded at 12 or 24 months. Non-responsive patients will be unblinded after 3 months and will be crossed over to a different group, if patient consents. Non-responsive patients may be unblinded and withdrawn from the study at any time.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: