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Lumbar Transforaminal Epidural Dexamethasone

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ClinicalTrials.gov Identifier: NCT01303354
Recruitment Status : Completed
First Posted : February 24, 2011
Last Update Posted : February 24, 2011
Sponsor:
Collaborator:
San Diego Veterans Healthcare System
Information provided by:
Ahadian, Farshad M., M.D.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Radicular; Neuropathic, Lumbar, Lumbosacral Procedure: Lumbar Transforaminal Epidural Steroid Injection Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lumbar Transforaminal Epidural Dexamethasone: A Prospective, Randomized, Double-Blind Clinical Trial
Study Start Date : April 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: DXM 4 mg
Dexamethasone 4 mg
 Procedure: Lumbar Transforaminal Epidural Steroid Injection
Experimental: DXM 8 mg
Dexamethasone 8 mg
 Procedure: Lumbar Transforaminal Epidural Steroid Injection
Experimental: DXM 12 mg
Dexamethasone 12 mg
 Procedure: Lumbar Transforaminal Epidural Steroid Injection


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01303354


Locations
United States, California
University of California, San Diego - Center for Pain Medicine
La Jolla, California, United States, 92037
San Diego VA Healthcare System
La Jolla, California, United States, 92161
Sponsors and Collaborators
Ahadian, Farshad M., M.D.
San Diego Veterans Healthcare System
Investigators
Principal Investigator: Farshad M Ahadian, M.D. University of California, San Diego
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Farshad M. Ahadian, M.D., Clinical Professor of Anesthesiology, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01303354     History of Changes
Other Study ID Numbers: UCSD IRB 080582
First Posted: February 24, 2011    Key Record Dates
Last Update Posted: February 24, 2011
Last Verified: February 2011

Keywords provided by Ahadian, Farshad M., M.D.:
Epidural, Transforaminal, Steroid Injection, Dexamethasone

Additional relevant MeSH terms:
Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Dexamethasone acetate
Dexamethasone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action