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

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

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