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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
University of California, San Diego - Center for Pain Medicine
La Jolla, California, United States
San Diego VA Healthcare System
La Jolla, California, United States
Radicular Pain Visual Analogue Scale (VAS) Score change from baseline
Reduction of pain from baseline at each time point.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks post injection
Oswestry Disability Index (ODI)- change from baseline
Improvement of disability level from baseline at each time point
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Day of and 1 week post injection
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