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| Name | Class |
|---|---|
| San Diego Veterans Healthcare System | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DXM 4 mg | Experimental | Dexamethasone 4 mg |
|
| DXM 8 mg | Experimental | Dexamethasone 8 mg |
|
| DXM 12 mg | Experimental | Dexamethasone 12 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumbar Transforaminal Epidural Steroid Injection | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry Disability Index (ODI)- change from baseline | Improvement of disability level from baseline at each time point | Baseline, 4 weeks, 8 weeks, 12 weeks post injection |
| Subject Global Impression of Change (SGIC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Farshad M Ahadian, M.D. | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego - Center for Pain Medicine | La Jolla | California | 92037 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22005659 | Derived | 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. |
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Allows comparison of Subject Global Impression of Change (SGIC) between groups at each time point
| 4 weeks, 8 weeks, 12 weeks |
| Subject Global Satisfaction Scale (SGSS) | Allows comparison of Subject Global Satisfaction Scale (SGSS) among groups at each time point | 4 weeks, 8 weeks, 12 weeks post injection |
| 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. | Day of and 1 week post injection |
| San Diego VA Healthcare System |
| La Jolla |
| California |
| 92161 |
| United States |