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

Early Phase 1CompletedNCT00370799

Pain Management Center of Paducah240 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

240

Conditions

Low Back Pain

Interventions

Caudal epidural injectionDRUG

group 1: Caudal epidural injection local anesthetics only

Caudal Epidural Injection with generic CelestoneDRUG

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

Caudal Epidural Injection with CelestoneDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Ambulatory Surgery Center

Paducah, Kentucky, United States

Outcomes

Primary Outcomes

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

Time frame: 1,3,6,12 months

Secondary Outcomes

To assess adverse events in all four groups.

Time frame: 1,3,6,12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.