Back to resultsLumbar Transforaminal Epidural Dexamethasone
Primary Purpose
Radicular; Neuropathic, Lumbar, Lumbosacral
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lumbar Transforaminal Epidural Steroid Injection
Sponsored by
About this trial
This is an interventional treatment trial for Radicular; Neuropathic, Lumbar, Lumbosacral focused on measuring Epidural, Transforaminal, Steroid Injection, Dexamethasone
Eligibility Criteria
Inclusion Criteria:
- adults age 18 years and older, unilateral lumbar radicular pain, baseline distal radicular lower extremity pain VAS score ≥ 5/10, and prior favorable response to TFESI
Exclusion Criteria:
- pregnancy, infection, coagulopathy, uncontrolled diabetes mellitus, history of allergy to iodinated contrast medium and interventional therapies for pain within 90 days prior to study enrollment
Sites / Locations
- University of California, San Diego - Center for Pain Medicine
- San Diego VA Healthcare System
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
DXM 4 mg
DXM 8 mg
DXM 12 mg
Arm Description
Dexamethasone 4 mg
Dexamethasone 8 mg
Dexamethasone 12 mg
Outcomes
Primary Outcome Measures
Radicular Pain Visual Analogue Scale (VAS) Score change from baseline
Reduction of pain from baseline at each time point.
Secondary Outcome Measures
Oswestry Disability Index (ODI)- change from baseline
Improvement of disability level from baseline at each time point
Subject Global Impression of Change (SGIC)
Allows comparison of Subject Global Impression of Change (SGIC) between groups at each time point
Subject Global Satisfaction Scale (SGSS)
Allows comparison of Subject Global Satisfaction Scale (SGSS) among groups at each time point
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
Subjects were specifically assessed for the following adverse events on day-of and one-week post injection: allergic reaction, neurovascular events, pain on injection, paresthesias during the procedure or dysesthesias post procedure, dural puncture, headache, meningismus, neck pain, arm pain, worsening of back pain, worsening of leg pain, facial flusing, mania, insomnia, agitation, hypertension, hyperglycemia. They were also asked to report any other side-effects or complications.
Full Information
NCT ID
NCT01303354
First Posted
February 4, 2011
Last Updated
February 23, 2011
Sponsor
Ahadian, Farshad M., M.D.
Collaborators
San Diego Veterans Healthcare System
1. Study Identification
Unique Protocol Identification Number
NCT01303354
Brief Title
Lumbar Transforaminal Epidural Dexamethasone
Official Title
Lumbar Transforaminal Epidural Dexamethasone: A Prospective, Randomized, Double-Blind Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ahadian, Farshad M., M.D.
Collaborators
San Diego Veterans Healthcare System
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to assess the effectiveness and safety of dexamethasone for transforaminal epidural steroid injection. A secondary aim of this study is to obtain data on the lowest most effective dose of dexamethasone for this treatment and the effective duration of effect.
Detailed Description
Transforaminal epidural steroid injections (TFESI) have been demonstrated to be an effective treatment for radicular pain. Over the last decade, rare but serious complications have been reported following transforaminal epidural steroid injections (TFESI). Recent research indicates that certain types of corticosteroids containing microscopic particles may be responsible for these adverse events. Dexamethasone (DXM) is a non-particulate cortico-steroid that has not been implicated in these adverse events. However, there is inadequate evidence up to date to support the use of Dexamethasone (DXM) for transforaminal epidural steroid injections (TFESI). This study aims to bridge that gap.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radicular; Neuropathic, Lumbar, Lumbosacral
Keywords
Epidural, Transforaminal, Steroid Injection, Dexamethasone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DXM 4 mg
Arm Type
Experimental
Arm Description
Dexamethasone 4 mg
Arm Title
DXM 8 mg
Arm Type
Experimental
Arm Description
Dexamethasone 8 mg
Arm Title
DXM 12 mg
Arm Type
Experimental
Arm Description
Dexamethasone 12 mg
Intervention Type
Procedure
Intervention Name(s)
Lumbar Transforaminal Epidural Steroid Injection
Primary Outcome Measure Information:
Title
Radicular Pain Visual Analogue Scale (VAS) Score change from baseline
Description
Reduction of pain from baseline at each time point.
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks post injection
Secondary Outcome Measure Information:
Title
Oswestry Disability Index (ODI)- change from baseline
Description
Improvement of disability level from baseline at each time point
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks post injection
Title
Subject Global Impression of Change (SGIC)
Description
Allows comparison of Subject Global Impression of Change (SGIC) between groups at each time point
Time Frame
4 weeks, 8 weeks, 12 weeks
Title
Subject Global Satisfaction Scale (SGSS)
Description
Allows comparison of Subject Global Satisfaction Scale (SGSS) among groups at each time point
Time Frame
4 weeks, 8 weeks, 12 weeks post injection
Title
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
Description
Subjects were specifically assessed for the following adverse events on day-of and one-week post injection: allergic reaction, neurovascular events, pain on injection, paresthesias during the procedure or dysesthesias post procedure, dural puncture, headache, meningismus, neck pain, arm pain, worsening of back pain, worsening of leg pain, facial flusing, mania, insomnia, agitation, hypertension, hyperglycemia. They were also asked to report any other side-effects or complications.
Time Frame
Day of and 1 week post injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adults age 18 years and older, unilateral lumbar radicular pain, baseline distal radicular lower extremity pain VAS score ≥ 5/10, and prior favorable response to TFESI
Exclusion Criteria:
pregnancy, infection, coagulopathy, uncontrolled diabetes mellitus, history of allergy to iodinated contrast medium and interventional therapies for pain within 90 days prior to study enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farshad M Ahadian, M.D.
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Diego - Center for Pain Medicine
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
San Diego VA Healthcare System
City
La Jolla
State/Province
California
ZIP/Postal Code
92161
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22005659
Citation
Ahadian FM, McGreevy K, Schulteis G. Lumbar transforaminal epidural dexamethasone: a prospective, randomized, double-blind, dose-response trial. Reg Anesth Pain Med. 2011 Nov-Dec;36(6):572-8. doi: 10.1097/AAP.0b013e318232e843.
Results Reference
derived
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Lumbar Transforaminal Epidural Dexamethasone
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