Trial | NCT00370799  Report issue

Title

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

  • Phase

    Early Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    methylprednisolone betamethasone ...

  • Study Participants

    240
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.

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 Started
Jan 31
2007
Primary Completion
Dec 31
2009
Study Completion
Mar 31
2010
Last Update
Aug 16
2013
Estimate

Drug Caudal epidural injection

group 1: Caudal epidural injection local anesthetics only

  • Other names: Group 1

Drug Caudal Epidural Injection with generic Celestone

Group 2. Caudal Epidural Injection local anesthetic with 6mg of non-particulate Celestone

  • Other names: Group 2

Drug Caudal Epidural Injection with Celestone

Group 3. Caudal Epidural Injection with local anesthetic with 6 mg of brand name Celestone

  • Other names: Group 3

Drug Caudal Epidural Injection with DepoMedrol

Group 4. local anesthetic with 40 mg of alcohol-free DepoMedrol

  • Other names: Group 4

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

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
No Results Posted