Lumbar Transforaminal Epidural Dexamethasone
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Radicular; Neuropathic, Lumbar, Lumbosacral |
Procedure: Lumbar Transforaminal Epidural Steroid Injection |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Lumbar Transforaminal Epidural Dexamethasone: A Prospective, Randomized, Double-Blind Clinical Trial |
- Radicular Pain Visual Analogue Scale (VAS) Score change from baseline [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks post injection ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Improvement of disability level from baseline at each time point
- Subject Global Impression of Change (SGIC) [ Time Frame: 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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.
| Enrollment: | 100 |
| Study Start Date: | April 2008 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| 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 |
More Information
No publications provided by Ahadian, Farshad M., M.D.
Additional 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 |
| Study First Received: | February 4, 2011 |
| Last Updated: | February 23, 2011 |
| Health Authority: | United States: Institutional Review Board |
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 Dexamethasone 21-phosphate BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013