Two Different Approaches During Fluoroscopically Guided Interlaminar Lumbar Epidural Steroid Injection

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01760317

Enrollment

106

Registered

2013-01-04

Start date

2010-08-31

Completion date

2013-05-31

Last updated

2015-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unilateral Lumbosacral Radiculopathy Pain

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.

Interventions

PROCEDUREMidline vs Parasagittal Lumbar Epidural Steroid Injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026