At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 3-arm Multi-center, Randomized Controlled Study Comparing Transforaminal Corticosteroid, Transforaminal Etanercept and Transforaminal Saline for Lumbosacral Radiculopathy
In Brief
A Phase 3 clinical trial evaluating etanercept, methylprednisolone, and 1 other intervention for Lumbosacral Radiculopathy. Completed, enrolled 84 participants across 2 sites.
Detailed Summary
Lumbosacral radiculopathy is one of the leading of cause of disability in the U.S. and worldwide. Among recent reviews evaluating epidural steroid injections, some 1 but not all 2 concluded them to be effective in the long-term. In our own double-blind, placebo-controlled study evaluating epidural etanercept, the results showed significant benefit in favor of the etanercept group, but no subject was included with a duration of pain \> 9 months, and the results of this study have yet to be replicated. Currently, epidural steroid injections are the most frequently performed procedures in pain clinics across the U.S. However, epidural steroids may benefit only a select group of patients. The literature on treating sciatica is notable for a lack of randomized comparative studies involving various treatments. The objective of this project is to conduct a 3-arm study to determine the efficacy of 1) transforaminal epidural corticosteroids; and 2) transforaminal epidural etanercept, in patients with lumbosacral radiculopathy.
Study Details
Timeline
Interventions
Two transforaminal epidural injections of 4 mg, two weeks apart
Two transforaminal epidural steroid injections with 60 mg, two weeks apart
Two transforaminal epidural saline injections, two weeks apart