Two Different Approaches During Fluoroscopically Guided Interlaminar Lumbar Epidural Steroid Injection
NCT ID: NCT01760317
Last Updated: 2015-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
106 participants
INTERVENTIONAL
2010-08-31
2013-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Midline
Midline Lumbar Epidural Steroid Injection
Midline vs Parasagittal Lumbar Epidural Steroid Injection
Parasagittal
Parasagittal Lumbar Epidural Steroid Injection
Midline vs Parasagittal Lumbar Epidural Steroid Injection
Interventions
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Midline vs Parasagittal Lumbar Epidural Steroid Injection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Kenneth D Candido
OTHER
Responsible Party
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Kenneth D Candido
Chairman of Anesthesia Department; Advocate Illinois Masonic Medical Center
Locations
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Chicago Anesthesia Pain Specialits
Chicago, Illinois, United States
Countries
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References
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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.
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.
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.
Other Identifiers
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Advocate-IRB-4917
Identifier Type: -
Identifier Source: org_study_id
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