Completed

NCT Number: NCT01760317

Two Different Approaches During Fluoroscopically Guided Interlaminar Lumbar Epidural Steroid Injection

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.

Completed

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Key information

Conditions

Unilateral Lumbosacral Radiculopathy Pain

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chicago Anesthesia Pain Specialits

Chicago, Illinois, 60657, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Midline vs Parasagittal Lumbar Epidural Steroid Injection

Procedure

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

Sponsors and collaborators

Lead sponsor

Kenneth D Candido

Other

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2013
First posted: Jan 4, 2013
Registry last updated: Feb 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.