Two Different Approaches During Fluoroscopically Guided Interlaminar Lumbar Epidural Steroid Injection

Kenneth D Candido

Status: Completed

Conditions: Unilateral Lumbosacral Radiculopathy Pain

Treatments: Procedure: Midline vs Parasagittal Lumbar Epidural Steroid Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT01760317

Advocate-IRB-4917

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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106 participants in 2 patient groups

Midline

Active Comparator group

Description:

Midline Lumbar Epidural Steroid Injection

Treatment:

Procedure: Midline vs Parasagittal Lumbar Epidural Steroid Injection

Parasagittal

Active Comparator group

Description:

Parasagittal Lumbar Epidural Steroid Injection

Treatment:

Procedure: Midline vs Parasagittal Lumbar Epidural Steroid Injection