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NCT03801356 · ClinicalTrials.gov registry record · Phase 4
Threshold Response of Lumbar Selective Nerve Root Block in Predicting Good Outcome Following Lumbar Foraminotomy
A Phase 4 study, sponsored by The Cleveland Clinic.
- Terminated
- Registry status
- Phase 4
- Development phase
- 11
- Enrollment target
NCT03801356: Clinical Trial Phase 4 study, sponsored by The Cleveland Clinic.
NCT03801356 is a Phase 4 study that was terminated before completion, run by The Cleveland Clinic. The registered enrollment target is 11 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03801356, a Phase 4 study, was terminated before completion, sponsored by The Cleveland Clinic.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 11 participants
- Enrollment target
Study Summary
SNRB, as measured by the change in pain and objective functional ability, can solicit crucial information regarding a patient's clinical picture and can predict a patient's outcome post-surgery. By using the walk test as an objective functional assessment, the aim is to better standardize the threshold for a positive response to SNRB. In summary, SNRB, despite utilized frequently in the diagnostic work-up with patients with lumbar radiculopathy, vary widely in their sensitivity and specificity. The reasons, as outlined above, are multifactorial. The proposed study aims to minimize the known limitations of these injections and prospectively define their positive and negative predictive value in a homogenous group of patients undergoing surgery for lumbar foraminal stenosis and radiculopathy. The design will define a threshold of response utilizing both subjective and objective measures and more accurately predict excellent results following surgery.
Primary Outcome
Aim: 0-2 point improvement The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' (0) and 'pain as bad as it could be' (10). The patient is asked to mark their pain level on the line between the two endpoints. The distance and change between '0' and the mark then defines the subject's pain. This will be measured at each subject visit.
Interventions
- DRUG Selective Nerve Root Block
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2018-08-23 |
| Est. Completion | 2020-12-15 |
| Phase | Phase 4 |
Why NCT03801356 stopped before completion
NCT03801356 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Selective Nerve Root Block is the first listed.
NCT03801356 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03801356 about?
NCT03801356 is a clinical study titled "Threshold Response of Lumbar Selective Nerve Root Block in Predicting Good Outcome Following Lumbar Foraminotomy". SNRB, as measured by the change in pain and objective functional ability, can solicit crucial information regarding a patient's clinical picture and can predict a patient's outcome post-surgery. By using the walk test as an objective functional assessment, the aim is to better standardize the thresh...
What is the current status of trial NCT03801356?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 11 participants. The study started on 2018-08-23. Estimated completion is 2020-12-15.
What interventions are being tested in trial NCT03801356?
The interventions under investigation include: Selective Nerve Root Block (DRUG).
Who is sponsoring clinical trial NCT03801356?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03801356's enrollment target sits among peer trials
11 1931st of 2000 higher than 61 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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