Two Different Approaches During Fluoroscopically Guided Interlaminar Lumbar Epidural Steroid Injection - Full Text View

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

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:

Boswell MV, Shah RV, Everett CR, Sehgal N, McKenzie Brown AM, Abdi S, Bowman RC 2nd, Deer TR, Datta S, Colson JD, Spillane WF, Smith HS, Lucas LF, Burton AW, Chopra P, Staats PS, Wasserman RA, Manchikanti L. Interventional techniques in the management of chronic spinal pain: evidence-based practice guidelines. Pain Physician. 2005 Jan;8(1):1-47.

Abdi S, Datta S, Trescot AM, Schultz DM, Adlaka R, Atluri SL, Smith HS, Manchikanti L. Epidural steroids in the management of chronic spinal pain: a systematic review. Pain Physician. 2007 Jan;10(1):185-212. Review.

Manchikanti L. The growth of interventional pain management in the new millennium: a critical analysis of utilization in the medicare population. Pain Physician. 2004 Oct;7(4):465-82.

Boswell MV, Trescot AM, Datta S, Schultz DM, Hansen HC, Abdi S, Sehgal N, Shah RV, Singh V, Benyamin RM, Patel VB, Buenaventura RM, Colson JD, Cordner HJ, Epter RS, Jasper JF, Dunbar EE, Atluri SL, Bowman RC, Deer TR, Swicegood JR, Staats PS, Smith HS, Burton AW, Kloth DS, Giordano J, Manchikanti L; American Society of Interventional Pain Physicians. Interventional techniques: evidence-based practice guidelines in the management of chronic spinal pain. Pain Physician. 2007 Jan;10(1):7-111.

Buenaventura RM, Datta S, Abdi S, Smith HS. Systematic review of therapeutic lumbar transforaminal epidural steroid injections. Pain Physician. 2009 Jan-Feb;12(1):233-51. Review.

Candido KD, Raghavendra MS, Chinthagada M, Badiee S, Trepashko DW. A prospective evaluation of iodinated contrast flow patterns with fluoroscopically guided lumbar epidural steroid injections: the lateral parasagittal interlaminar epidural approach versus the transforaminal epidural approach. Anesth Analg. 2008 Feb;106(2):638-44, table of contents. doi: 10.1213/ane.0b013e3181605e9b.

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
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013