Two Different Approaches During Fluoroscopically Guided Interlaminar Lumbar Epidural Steroid Injection

Study Overview
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Brief Summary
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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.

Official Title
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Midline vs Lateral Parasagittal Approach During Fluoroscopically Guided Interlaminar Lumbar Epidural Steroid Injection: the Role of Concordant Pressure Paresthesia in Determing Outcome.

Conditions
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Unilateral Lumbosacral Radiculopathy Pain

Intervention / Treatment
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* Procedure: Midline vs Parasagittal Lumbar Epidural Steroid Injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Midline<br>Midline Lumbar Epidural Steroid Injection | Procedure: Midline vs Parasagittal Lumbar Epidural Steroid Injection<br> <br> |
| Active Comparator: Parasagittal<br>Parasagittal Lumbar Epidural Steroid Injection | Procedure: Midline vs Parasagittal Lumbar Epidural Steroid Injection<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Pain Scores from baseline after Lumbar Epidural Steroid Injection |  | Days 1, 7, 14, 21, 28, 60, 120, 180, 360 | 
| Pressure Paresthesia during injection |  | 1 day (During Lumbar Epidural Steroid Injection) | 
| Quality of life improvement change after Lumbar Epidural Steroid Injection |  | Days 1, 7, 14, 21, 28, 60, 120, 180, 360 |