Radicular; Neuropathic, Lumbar, Lumbosacral
Conditions
Keywords
Epidural, Transforaminal, Steroid Injection, Dexamethasone
Brief summary
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
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.
Interventions
PROCEDURELumbar Transforaminal Epidural Steroid Injection
Sponsors
San Diego Veterans Healthcare System
Ahadian, Farshad M., M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radicular Pain Visual Analogue Scale (VAS) Score change from baseline | Baseline, 4 weeks, 8 weeks, 12 weeks post injection | Reduction of pain from baseline at each time point. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index (ODI)- change from baseline | 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) | 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) | 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 | 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. |
Countries
United States
Outcome results
None listed