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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.
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.
Secondary Outcome Measures
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:
Accepts Healthy Volunteers:
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
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