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NCT01995461 · ClinicalTrials.gov registry record · NA
Bilateral Transforaminal Epidural Steroid Injections for Degenerative Lumbar Spinal Stenosis
A NA study, sponsored by Marshfield Clinic Research Foundation.
- Terminated
- Registry status
- NA
- Development phase
- 26
- Enrollment target
NCT01995461: Clinical Trial NA study, sponsored by Marshfield Clinic Research Foundation.
NCT01995461 is a NA study that was terminated before completion, run by Marshfield Clinic Research Foundation. The registered enrollment target is 26 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01995461, a NA study, was terminated before completion, sponsored by Marshfield Clinic Research Foundation.
- TERMINATED
- Registry status
- NA
- Development phase
- 26 participants
- Enrollment target
Study Summary
The most common forms of injection used for the treatment of degenerative lumbar spinal stenosis (DLSS) patients with neurogenic claudication (NC) are the caudal and inter-laminar epidural injections of anesthetic and steroid. Unilateral transforaminal epidural steroid injections (TESI) are also used to alleviate patients' symptoms of NC from DLSS, particularly in patients whose level of stenosis is L4-5 or higher. However, these unilateral injections do not cross the midline, so in cases of lower extremity pain and symptoms on both sides, a bilateral TESI would probably be more beneficial. To date, there have not been any well designed prospective studies to determine the effectiveness of bilateral TESI below the level of stenosis in DLSS patients with NC. Therefore, the goal of this prospective, non-randomized case-series outcome study is to evaluate the effectiveness of BTESI in alleviating symptoms of NC, as well as improving function in patients with DLSS. The hypothesis is that BTESI at the level below the most stenotic segment of the central canal of the lumbar spine decreases symptoms of NC and improves function in patients with DLSS.
Primary Outcome
change from baseline (pre-1st injection) pain score, based on a numeric pain scale of 0-10(most severe pain), at 6 months post-1st injection
Interventions
- DRUG bilateral transforaminal epidural steroid injections
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2013-05 |
| Est. Completion | 2014-06 |
| Phase | NA |
Why NCT01995461 stopped before completion
NCT01995461 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which bilateral transforaminal epidural steroid injections is the first listed.
NCT01995461 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01995461 about?
NCT01995461 is a clinical study titled "Bilateral Transforaminal Epidural Steroid Injections for Degenerative Lumbar Spinal Stenosis". The most common forms of injection used for the treatment of degenerative lumbar spinal stenosis (DLSS) patients with neurogenic claudication (NC) are the caudal and inter-laminar epidural injections of anesthetic and steroid. Unilateral transforaminal epidural steroid injections (TESI) are also use...
What is the current status of trial NCT01995461?
This trial is currently terminated. It is a NA study. The enrollment target is 26 participants. The study started on 2013-05. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01995461?
The interventions under investigation include: bilateral transforaminal epidural steroid injections (DRUG).
Who is sponsoring clinical trial NCT01995461?
This trial is sponsored by Marshfield Clinic Research Foundation, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01995461's enrollment target sits among peer trials
26 1710th of 2000 higher than 289 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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