Lumbar Transforaminal Epidural Dexamethasone

This study has been completed.
Sponsor:
Collaborator:
San Diego Veterans Healthcare System
Information provided by:
Ahadian, Farshad M., M.D.
ClinicalTrials.gov Identifier:
NCT01303354
First received: February 4, 2011
Last updated: February 23, 2011
Last verified: February 2011
  Purpose

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 Intervention
Radicular; Neuropathic, Lumbar, Lumbosacral
Procedure: Lumbar Transforaminal Epidural Steroid Injection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lumbar Transforaminal Epidural Dexamethasone: A Prospective, Randomized, Double-Blind Clinical Trial

Resource links provided by NLM:


Further study details as provided by Ahadian, Farshad M., M.D.:

Primary Outcome Measures:
  • Radicular Pain Visual Analogue Scale (VAS) Score change from baseline [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks post injection ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Improvement of disability level from baseline at each time point

  • Subject Global Impression of Change (SGIC) [ Time Frame: 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 100
Study Start Date: April 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01303354

Locations
United States, California
San Diego VA Healthcare System
La Jolla, California, United States, 92161
University of California, San Diego - Center for Pain Medicine
La Jolla, California, United States, 92037
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

No publications provided by Ahadian, Farshad M., M.D.

Additional 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
Study First Received: February 4, 2011
Last Updated: February 23, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Radiculopathy
Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Diseases
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014