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Two Different Approaches During Fluoroscopically Guided Interlaminar Lumbar Epidural Steroid Injection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01760317
First Posted: January 4, 2013
Last Update Posted: February 5, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kenneth D Candido, Chicago Anesthesia Pain Specialists
  Purpose

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.

Condition Intervention
Unilateral Lumbosacral Radiculopathy Pain Procedure: Midline vs Parasagittal Lumbar Epidural Steroid Injection

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Midline vs Lateral Parasagittal Approach During Fluoroscopically Guided Interlaminar Lumbar Epidural Steroid Injection: the Role of Concordant Pressure Paresthesia in Determing Outcome.

Further study details as provided by Kenneth D Candido, Chicago Anesthesia Pain Specialists:

Primary Outcome Measures:
  • 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 ]

Enrollment: 106
Study Start Date: August 2010
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Midline
Midline Lumbar Epidural Steroid Injection
Procedure: Midline vs Parasagittal Lumbar Epidural Steroid Injection
Active Comparator: Parasagittal
Parasagittal Lumbar Epidural Steroid Injection
Procedure: Midline vs Parasagittal Lumbar Epidural Steroid Injection

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760317


Locations
United States, Illinois
Chicago Anesthesia Pain Specialits
Chicago, Illinois, United States, 60657
Sponsors and Collaborators
Kenneth D Candido
  More Information

Publications:

Responsible Party: Kenneth D Candido, Chairman of Anesthesia Department; Advocate Illinois Masonic Medical Center, Chicago Anesthesia Pain Specialists
ClinicalTrials.gov Identifier: NCT01760317     History of Changes
Other Study ID Numbers: Advocate-IRB-4917
First Submitted: December 21, 2012
First Posted: January 4, 2013
Last Update Posted: February 5, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases