Effectiveness of Caudal Epidural Injections in Treatment of Chronic Low Back and Lower Extremity Pain

Study Overview
=================
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

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

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

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Drug: Caudal epidural injection
* Drug: Caudal Epidural Injection with generic Celestone
* Drug: Caudal Epidural Injection with Celestone
* Drug: Caudal Epidural Injection with DepoMedrol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age History of chronic, function-limiting low back pain of at least 6 months duration Able to give voluntary, written informed consent to participate, Able to understand the investigation, cooperate with the procedures, and willing to return for follow-up No recent surgical procedures within last three months Exclusion Criteria: Cauda Equina symptoms and/or compressive radiculopathy Narcotic use of no greater than 100mg/day hydrocodone, 60mg Methadone. or 100mg morphine Uncontrolled major Depression or uncontrolled psychiatric disorder Uncontrolled or acute medical illnesses Chronic severe conditions that could interfere with outcome assessments Women who are pregnant or lactating Subjects who have participated in a clinical study with an investigational product within 30 days of enrollment Patients with multiple complaints involving concomitant hip osteoarthritis Inability to achieve proper positioning and inability to understand informed consent and protocol History of adverse reaction to local anesthetic or anti-inflammatory drugs and history of gastrointestinal bleeding or ulcers

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: local anesthetic<br>Group 1. local anesthetics only | Drug: Caudal epidural injection<br>* group 1: Caudal epidural injection local anesthetics only<br>* Other names: Group 1;|
| Active Comparator: Local anesthetic with generic Celestone<br>Group 2. local anesthetic with 6mg of non-particulate Celestone | Drug: Caudal Epidural Injection with generic Celestone<br>* Group 2. Caudal Epidural Injection local anesthetic with 6mg of non-particulate Celestone<br>* Other names: Group 2;|
| Active Comparator: Local anesthetic with Celestone<br>Group 3. local anesthetic with 6 mg of brand nameCelestone | Drug: Caudal Epidural Injection with Celestone<br>* Group 3. Caudal Epidural Injection with local anesthetic with 6 mg of brand name Celestone<br>* Other names: Group 3;|
| Active Comparator: Local anesthetic with DepoMedrol<br>Group 4. local anesthetic with 40 mg of alcohol-free DepoMedrol | Drug: Caudal Epidural Injection with DepoMedrol<br>* Group 4. local anesthetic with 40 mg of alcohol-free DepoMedrol<br>* Other names: Group 4;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess adverse events in all four groups. |  | 1,3,6,12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Caudal Epidural injections, lumbar disc herniation, spinal stenosis, discogenic pain, post-lumbar laminectomy syndrome