Status:
COMPLETED
Effectiveness of Caudal Epidural Injections in Treatment of Chronic Low Back and Lower Extremity Pain
Lead Sponsor:
Pain Management Center of Paducah
Conditions:
Low Back Pain
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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 compar...
Detailed 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, prospe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00370799
Start Date
January 1 2007
End Date
March 1 2010
Last Update
August 16 2013
Active Locations (1)
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1
Ambulatory Surgery Center
Paducah, Kentucky, United States, 42001