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

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pain Management Center of Paducah
• Treatments: Anesthetics; Anesthetics, Local; Betamethasone; Betamethasone benzoate; Betamethasone sodium phosphate; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

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