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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
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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| local anesthetic | Active Comparator | Group 1. local anesthetics only |
|
| Local anesthetic with generic Celestone | Active Comparator | Group 2. local anesthetic with 6mg of non-particulate Celestone |
|
| Local anesthetic with Celestone | Active Comparator | Group 3. local anesthetic with 6 mg of brand nameCelestone |
|
| Local anesthetic with DepoMedrol | Active Comparator | Group 4. local anesthetic with 40 mg of alcohol-free DepoMedrol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caudal epidural injection | Drug | group 1: Caudal epidural injection local anesthetics only |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate for differences between the patients in various groups in the physical function and pain at 1, 3, 6, and 12 months post treatment | 1,3,6,12 months |
| Measure | Description | Time Frame |
|---|---|---|
| To assess adverse events in all four groups. | 1,3,6,12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laxmaiah Manchikanti, MD | Ambulatory Surgery Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ambulatory Surgery Center | Paducah | Kentucky | 42001 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22828681 | Derived | Manchikanti L, Singh V, Cash KA, Pampati V, Damron KS, Boswell MV. Effect of fluoroscopically guided caudal epidural steroid or local anesthetic injections in the treatment of lumbar disc herniation and radiculitis: a randomized, controlled, double blind trial with a two-year follow-up. Pain Physician. 2012 Jul-Aug;15(4):273-86. | |
| 21267039 |
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| Caudal Epidural Injection with generic Celestone | Drug | Group 2. Caudal Epidural Injection local anesthetic with 6mg of non-particulate Celestone |
|
|
| Caudal Epidural Injection with Celestone | Drug | Group 3. Caudal Epidural Injection with local anesthetic with 6 mg of brand name Celestone |
|
|
| Caudal Epidural Injection with DepoMedrol | Drug | Group 4. local anesthetic with 40 mg of alcohol-free DepoMedrol |
|
|
| Manchikanti L, Cash KA, McManus CD, Pampati V, Smith HS. One-year results of a randomized, double-blind, active controlled trial of fluoroscopic caudal epidural injections with or without steroids in managing chronic discogenic low back pain without disc herniation or radiculitis. Pain Physician. 2011 Jan-Feb;14(1):25-36. |
| 21102963 | Derived | Manchikanti L, Singh V, Cash KA, Pampati V, Datta S. Management of pain of post lumbar surgery syndrome: one-year results of a randomized, double-blind, active controlled trial of fluoroscopic caudal epidural injections. Pain Physician. 2010 Nov-Dec;13(6):509-21. |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D007405 | Intervertebral Disc Displacement |
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
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| ID | Term |
|---|---|
| D001623 | Betamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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