1. To demonstrate clinically significant improvements in patients undergoing lumbar interlaminar epidurals. Improvement will be assessed in relation to the clinical outcome measures of pain and function. 2. To evaluate and compare the adverse event profile in all patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
1. Lumbar interlaminar epidural injections under fluoroscopy 2. Epidural tray and needle 3. Drugs: 0.5% Xylocaine and non-particulate Celestone
1. Lumbar interlaminar epidural injections under fluoroscopy 2. Epidural tray and needle 3. Drugs: 0.5% Xylocaine and non-particulate Celestone
Ambulatory Surgery Center
Paducah, Kentucky, United States
To demonstrate clinically significant improvement or lack thereof with the lumbar interlaminar epidural patients with or without steroids.
Time frame: Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months.
To evaluate differences in outcomes in patients receiving steroids compared to those patients randomized to the local anesthetic group who did not receive steroids.
Time frame: Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months.
To evaluate and compare the adverse event profile in all patients.
Time frame: Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months.
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