Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Two Different Approaches During Fluoroscopically Guided Interlaminar Lumbar Epidural Steroid Injection

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kenneth D Candido, Chicago Anesthesia Pain Specialists
ClinicalTrials.gov Identifier:
NCT01760317
First received: December 21, 2012
Last updated: January 3, 2013
Last verified: January 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 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 ] [ Designated as safety issue: No ]
  • Pressure Paresthesia during injection [ Time Frame: 1 day (During Lumbar Epidural Steroid Injection) ] [ Designated as safety issue: No ]
  • Quality of life improvement change after Lumbar Epidural Steroid Injection [ Time Frame: Days 1, 7, 14, 21, 28, 60, 120, 180, 360 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2010
Estimated Primary Completion Date: February 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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: December 21, 2012
Last Updated: January 3, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 27, 2014