Midline vs Lateral Parasagittal Approach During Fluoroscopically Guided Interlaminar Lumbar Epidural Steroid Injection: the Role of Concordant Pressure Paresthesia in Determing Outcome.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 106
- Locations
- 1
- Primary Endpoint
- Changes in Pain Scores from baseline after Lumbar Epidural Steroid Injection
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18- 80 years old
- •History of low back pain and unilateral lumbosacral radiculopathy pain
- •Lumbar disk disease including disk herniations, bulging discs, and degenerated discs, where at least 50% of the disk height is preserved respective to contiguous levels
Exclusion Criteria
- •Discogenic pain without radiculopathy pain
- •History of previous spinal surgery
- •LESI(s) in the past year
- •Allergy to methylprednisolone, or lidocaine, or iodine-based contrast
- •Concurrent use of systemic steroid medications
- •Opioid habituation
- •Pregnancy
Arms & Interventions
Midline
Midline Lumbar Epidural Steroid Injection
Intervention: Midline vs Parasagittal Lumbar Epidural Steroid Injection (Procedure)
Parasagittal
Parasagittal Lumbar Epidural Steroid Injection
Intervention: Midline vs Parasagittal Lumbar Epidural Steroid Injection (Procedure)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Kenneth D Candido
Chairman of Anesthesia Department; Advocate Illinois Masonic Medical Center
Chicago Anesthesia Pain Specialists