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Two Different Approaches During Fluoroscopically Guided Interlaminar Lumbar Epidural Steroid Injection

Primary Purpose

Unilateral Lumbosacral Radiculopathy Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Midline vs Parasagittal Lumbar Epidural Steroid Injection
Sponsored by
Kenneth D Candido
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unilateral Lumbosacral Radiculopathy Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chicago Anesthesia Pain Specialits

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Midline

Parasagittal

Arm Description

Midline Lumbar Epidural Steroid Injection

Parasagittal Lumbar Epidural Steroid Injection

Outcomes

Primary Outcome Measures

Changes in Pain Scores from baseline after Lumbar Epidural Steroid Injection
Pressure Paresthesia during injection
Quality of life improvement change after Lumbar Epidural Steroid Injection

Secondary Outcome Measures

Full Information

First Posted
December 21, 2012
Last Updated
February 3, 2015
Sponsor
Kenneth D Candido
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1. Study Identification

Unique Protocol Identification Number
NCT01760317
Brief Title
Two Different Approaches During Fluoroscopically Guided Interlaminar Lumbar Epidural Steroid Injection
Official Title
Midline vs Lateral Parasagittal Approach During Fluoroscopically Guided Interlaminar Lumbar Epidural Steroid Injection: the Role of Concordant Pressure Paresthesia in Determing Outcome.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kenneth D Candido

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unilateral Lumbosacral Radiculopathy Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Midline
Arm Type
Active Comparator
Arm Description
Midline Lumbar Epidural Steroid Injection
Arm Title
Parasagittal
Arm Type
Active Comparator
Arm Description
Parasagittal Lumbar Epidural Steroid Injection
Intervention Type
Procedure
Intervention Name(s)
Midline vs Parasagittal Lumbar Epidural Steroid Injection
Primary Outcome Measure Information:
Title
Changes in Pain Scores from baseline after Lumbar Epidural Steroid Injection
Time Frame
Days 1, 7, 14, 21, 28, 60, 120, 180, 360
Title
Pressure Paresthesia during injection
Time Frame
1 day (During Lumbar Epidural Steroid Injection)
Title
Quality of life improvement change after Lumbar Epidural Steroid Injection
Time Frame
Days 1, 7, 14, 21, 28, 60, 120, 180, 360

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Chicago Anesthesia Pain Specialits
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16850041
Citation
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.
Results Reference
background
PubMed Identifier
17256030
Citation
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.
Results Reference
background
PubMed Identifier
16858489
Citation
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.
Results Reference
background
PubMed Identifier
17256025
Citation
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.
Results Reference
background
PubMed Identifier
19165306
Citation
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.
Results Reference
background
PubMed Identifier
18227326
Citation
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.
Results Reference
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Two Different Approaches During Fluoroscopically Guided Interlaminar Lumbar Epidural Steroid Injection

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