Effectiveness of Caudal Epidural Injections in Treatment of Chronic Low Back and Lower Extremity Pain
Completed · Early Phase 1
Conditions studied: Low Back Pain
In brief
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
Key facts
- Study ID
- NCT00370799
- Run by
- Pain Management Center of Paducah
- People needed
- 240
- Starts
- 2007-01-01
- Expected to finish
- 2010-03-01
- Last updated by the study team
- 2013-08-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Ambulatory Surgery Center — Paducah, Kentucky, United States
Full record on ClinicalTrials.gov
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