Clinical Trial: Two Different Approaches During Fluoroscopically Guided Interlaminar Lumbar Epidural Steroid Injection
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Midline vs Lateral Parasagittal Approach During Fluoroscopically Guided Interlaminar Lumbar Epidural Steroid Injection: the Role of Concordant Pressure Paresthesia in Dete
Brief Summary:
The purpose of this study is to compare two different approaches (midline and parasagittal) during interlaminar lumbar epidural steroid injection (LESI), and to verify the role of concordant pressure paresthesia occurring during the LESI in determining outcome.
The investigators are planning to include 100 patients, undergoing LESI for radicular low back pain. This will be single-blinded randomized study. Every patient will receive the same medication we would use regardless of participating in the study. The patients will be randomly assigned to one of two groups, based on the approach:
- Group I (50 patients) - will get LESI using midline (MIL) approach.
- Group II (50 patients) - will get LESI using parasagittal interlaminar (PIL) approach.
Detailed Summary:
Sponsor: Kenneth D Candido
Current Primary Outcome:
- Changes in Pain Scores from baseline after Lumbar Epidural Steroid Injection [ Time Frame: Days 1, 7, 14, 21, 28, 60, 120, 180, 360 ]
- Pressure Paresthesia during injection [ Time Frame: 1 day (During Lumbar Epidural Steroid Injection) ]
- Quality of life improvement change after Lumbar Epidural Steroid Injection [ Time Frame: Days 1, 7, 14, 21, 28, 60, 120, 180, 360 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Chicago Anesthesia Pain Specialists
Dates:
Date Received: December 21, 2012
Date Started: August 2010
Date Completion:
Last Updated: February 3, 2015
Last Verified: February 2015
