Lumbar Transforaminal Epidural Dexamethasone

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Lumbar Transforaminal Epidural Dexamethasone: A Prospective, Randomized, Double-Blind Clinical Trial

Conditions
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Radicular; Neuropathic, Lumbar, Lumbosacral

Intervention / Treatment
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* Procedure: Lumbar Transforaminal Epidural Steroid Injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DXM 4 mg<br>Dexamethasone 4 mg | Procedure: Lumbar Transforaminal Epidural Steroid Injection<br> <br> |
| Experimental: DXM 8 mg<br>Dexamethasone 8 mg | Procedure: Lumbar Transforaminal Epidural Steroid Injection<br> <br> |
| Experimental: DXM 12 mg<br>Dexamethasone 12 mg | Procedure: Lumbar Transforaminal Epidural Steroid Injection<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epidural, Transforaminal, Steroid Injection, Dexamethasone