Two Different Approaches During Fluoroscopically Guided Interlaminar Lumbar Epidural Steroid Injection

Not Applicable

Completed

• Conditions: Unilateral Lumbosacral Radiculopathy Pain
• Interventions: Procedure: Midline vs Parasagittal Lumbar Epidural Steroid Injection

• Registration Number: NCT01760317
• Lead Sponsor: Kenneth D Candido

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 Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2012-12-21
• Study First Submitted QC: 2013-01-03
• Study First Posted: 2013-01-04
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-03
• Last Update Posted: 2015-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parasagittal	Midline vs Parasagittal Lumbar Epidural Steroid Injection	Parasagittal Lumbar Epidural Steroid Injection
Midline	Midline vs Parasagittal Lumbar Epidural Steroid Injection	Midline Lumbar Epidural Steroid Injection

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Chicago Anesthesia Pain Specialits; 🇺🇸 Chicago, Illinois, United States