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

Pain Management Center of Paducah

Status and phase: Completed; Early Phase 1

Conditions: Low Back Pain

Treatments: Drug: Caudal Epidural Injection with generic Celestone; Drug: Caudal Epidural Injection with DepoMedrol; Drug: Caudal Epidural Injection with Celestone; Drug: Caudal epidural injection

Study type: Interventional

Funder types: Other

Identifiers

NCT00370799

protocol 10

Details and patient eligibility

About

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

Full 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

Enrollment: 240 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 4 patient groups

local anesthetic

Active Comparator group

Description:

Group 1. local anesthetics only

Treatment:

Drug: Caudal epidural injection

Local anesthetic with generic Celestone

Active Comparator group

Description:

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

Treatment:

Drug: Caudal Epidural Injection with generic Celestone

Local anesthetic with Celestone

Active Comparator group

Description:

Group 3. local anesthetic with 6 mg of brand nameCelestone

Treatment:

Drug: Caudal Epidural Injection with Celestone

Local anesthetic with DepoMedrol

Active Comparator group

Description:

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

Treatment:

Drug: Caudal Epidural Injection with DepoMedrol