Clinical trial NCT01303354: Lumbar Transforaminal Epidural Dexamethasone
Official title: Lumbar Transforaminal Epidural Dexamethasone: A Prospective, Randomized, Double-Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radicular; Neuropathic, Lumbar, Lumbosacral
Keywords: Epidural, Transforaminal, Steroid Injection, Dexamethasone
Lead sponsor: Ahadian, Farshad M., M.D.
Sponsor class: INDIV
Collaborators: name: San Diego Veterans Healthcare System
First posted: 2011-02-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Radicular Pain Visual Analogue Scale (VAS) Score change from baseline
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks post injection
Secondary outcomes:
measure: Oswestry Disability Index (ODI)- change from baseline
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks post injection
measure: Subject Global Impression of Change (SGIC)
timeFrame: 4 weeks, 8 weeks, 12 weeks
measure: Subject Global Satisfaction Scale (SGSS)
timeFrame: 4 weeks, 8 weeks, 12 weeks post injection
measure: Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Day of and 1 week post injection
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego - Center for Pain Medicine
state: California
city: La Jolla
country: United States
facility: San Diego VA Healthcare System
state: California
Study officials:
affiliation: University of California, San Diego
name: Farshad M Ahadian, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ahadian FM, McGreevy K, Schulteis G. Lumbar transforaminal epidural dexamethasone: a prospective, randomized, double-blind, dose-response trial. Reg Anesth Pain Med. 2011 Nov-Dec;36(6):572-8. doi: 10.1097/AAP.0b013e318232e843.