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NCT00733096 · ClinicalTrials.gov registry record · Phase 2

A 3-arm Multi-center, Randomized Controlled Study Comparing Transforaminal Corticosteroid, Transforaminal Etanercept and Transforaminal Saline for Lumbosacral Radiculopathy

A Phase 2 study, sponsored by Johns Hopkins University.

Completed
Registry status
Phase 2
Development phase
84
Enrollment target

NCT00733096: Completed Phase 2 study, sponsored by Johns Hopkins University.

NCT00733096 is a Phase 2 study that has completed, run by Johns Hopkins University. The registered enrollment target is 84 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00733096, a Phase 2 study, has completed, sponsored by Johns Hopkins University.

COMPLETED
Registry status
Phase 2
Development phase
84 participants
Enrollment target

Study 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.

Primary Outcome

0-10 pain score. 0= no pain, 10= worst imaginable pain.

Interventions

  • DRUG methylprednisolone
  • DRUG normal saline
  • DRUG etanercept

Trial Details

FieldValue
Enrollment Target 84 participants
Start Date 2008-08
Est. Completion 2011-03
Phase Phase 2
Johns Hopkins University

1,448 total trials

What the finished NCT00733096 record still lists

NCT00733096 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower).

The record links to 0 conditions, and to 3 interventions - of which methylprednisolone is the first listed.

NCT00733096 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00733096 about?

NCT00733096 is a clinical study titled "A 3-arm Multi-center, Randomized Controlled Study Comparing Transforaminal Corticosteroid, Transforaminal Etanercept and Transforaminal Saline for Lumbosacral Radiculopathy". 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 e...

What is the current status of trial NCT00733096?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2008-08. Estimated completion is 2011-03.

What interventions are being tested in trial NCT00733096?

The interventions under investigation include: methylprednisolone (DRUG), normal saline (DRUG), etanercept (DRUG).

Who is sponsoring clinical trial NCT00733096?

This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00733096's enrollment target sits among peer trials

84 822nd of 2000 higher than 1,173 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00733096, the US trial registry maintained by the National Library of Medicine. NCT00733096 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.