Lumbar Transforaminal Epidural Dexamethasone
1 other identifier
interventional
100
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2008
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 4, 2011
CompletedFirst Posted
Study publicly available on registry
February 24, 2011
CompletedFebruary 24, 2011
February 1, 2011
2.2 years
February 4, 2011
February 23, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Radicular Pain Visual Analogue Scale (VAS) Score change from baseline
Reduction of pain from baseline at each time point.
Baseline, 4 weeks, 8 weeks, 12 weeks post injection
Secondary Outcomes (4)
Oswestry Disability Index (ODI)- change from baseline
Baseline, 4 weeks, 8 weeks, 12 weeks post injection
Subject Global Impression of Change (SGIC)
4 weeks, 8 weeks, 12 weeks
Subject Global Satisfaction Scale (SGSS)
4 weeks, 8 weeks, 12 weeks post injection
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
Day of and 1 week post injection
Study Arms (3)
DXM 4 mg
EXPERIMENTALDexamethasone 4 mg
DXM 8 mg
EXPERIMENTALDexamethasone 8 mg
DXM 12 mg
EXPERIMENTALDexamethasone 12 mg
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ahadian, Farshad M., M.D.lead
- San Diego Veterans Healthcare Systemcollaborator
Study Sites (2)
University of California, San Diego - Center for Pain Medicine
La Jolla, California, 92037, United States
San Diego VA Healthcare System
La Jolla, California, 92161, United States
Related Publications (1)
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.
PMID: 22005659DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Farshad M Ahadian, M.D.
University of California, San Diego
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDIV
Study Record Dates
First Submitted
February 4, 2011
First Posted
February 24, 2011
Study Start
April 1, 2008
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
February 24, 2011
Record last verified: 2011-02