Lumbar Transforaminal Epidural Dexamethasone
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ClinicalTrials.gov Identifier: NCT01303354 |
Recruitment Status
:
Completed
First Posted
: February 24, 2011
Last Update Posted
: February 24, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Radicular; Neuropathic, Lumbar, Lumbosacral | Procedure: Lumbar Transforaminal Epidural Steroid Injection | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Lumbar Transforaminal Epidural Dexamethasone: A Prospective, Randomized, Double-Blind Clinical Trial |
Study Start Date : | April 2008 |
Actual Primary Completion Date : | June 2010 |
Actual Study Completion Date : | June 2010 |
Arm | Intervention/treatment |
---|---|
Experimental: DXM 4 mg
Dexamethasone 4 mg
|
Procedure: Lumbar Transforaminal Epidural Steroid Injection |
Experimental: DXM 8 mg
Dexamethasone 8 mg
|
Procedure: Lumbar Transforaminal Epidural Steroid Injection |
Experimental: DXM 12 mg
Dexamethasone 12 mg
|
Procedure: Lumbar Transforaminal Epidural Steroid Injection |
- Radicular Pain Visual Analogue Scale (VAS) Score change from baseline [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks post injection ]Reduction of pain from baseline at each time point.
- Oswestry Disability Index (ODI)- change from baseline [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks post injection ]Improvement of disability level from baseline at each time point
- Subject Global Impression of Change (SGIC) [ Time Frame: 4 weeks, 8 weeks, 12 weeks ]Allows comparison of Subject Global Impression of Change (SGIC) between groups at each time point
- Subject Global Satisfaction Scale (SGSS) [ Time Frame: 4 weeks, 8 weeks, 12 weeks post injection ]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 [ Time Frame: Day of and 1 week post injection ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01303354
United States, California | |
University of California, San Diego - Center for Pain Medicine | |
La Jolla, California, United States, 92037 | |
San Diego VA Healthcare System | |
La Jolla, California, United States, 92161 |
Principal Investigator: | Farshad M Ahadian, M.D. | University of California, San Diego |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Farshad M. Ahadian, M.D., Clinical Professor of Anesthesiology, University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT01303354 History of Changes |
Other Study ID Numbers: |
UCSD IRB 080582 |
First Posted: | February 24, 2011 Key Record Dates |
Last Update Posted: | February 24, 2011 |
Last Verified: | February 2011 |
Keywords provided by Ahadian, Farshad M., M.D.:
Epidural, Transforaminal, Steroid Injection, Dexamethasone |
Additional relevant MeSH terms:
Radiculopathy Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Dexamethasone acetate Dexamethasone BB 1101 Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |