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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 is a Phase 4 study that was terminated before completion, run by The Cleveland Clinic. The registered enrollment target is 11 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03801356
The ClinicalTrials.gov registry entry for NCT03801356 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Selective Nerve Root Block is the first listed.
NCT03801356 reports 0 study locations.
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.
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