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Completed

NCT Number: NCT01303354

Lumbar Transforaminal Epidural Dexamethasone

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.

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Key information

Conditions

Radicular; Neuropathic, Lumbar, Lumbosacral

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Diego VA Healthcare System, La Jolla, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lumbar Transforaminal Epidural Steroid Injection

Procedure

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

Sponsors and collaborators

Lead sponsor

Ahadian, Farshad M., M.D.

Indiv

Collaborators

  • San Diego Veterans Healthcare System

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 24, 2011
Registry last updated
Feb 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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