NCT04182997 Subjective Intraoperative Use of Epidural Steroid Administration Following Discectomy
| NCT ID | NCT04182997 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Missouri-Columbia |
| Condition | Lumbar Disc Herniation |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2019-11-21 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 200 participants in total. It began in 2019-11-21 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to determine a grading system for inflammation in lumbar disc herniation and which groups, if any, benefit most from the administration of an intra-operative epidural steroid.
Eligibility Criteria
Inclusion Criteria: * Presenting to the University of Missouri hospital system - including the University of Missouri Hospital and Missouri Orthopaedic Institute - with a clinical assessment indicative of a lumbar disc herniation * Failed conservative treatment - rest, anti-inflammatory medications, physical therapy * Radiculopathy present - positive tension signs or sensory/motor neurologic deficits present * Recent MRI confirming single-level lumbar disc herniation corresponding to clinical evaluation Exclusion Criteria: * Concomitant spinal stenosis, segmental instability, or spondylolisthesis * Previous surgery at the affected level or recurrent herniation * Underlying disease that may affect response to steroids - immunocompromise, use of chronic steroids or immunosuppression * Pregnancy - qualitative human chorionic gonadotropin (hCG) testing will be performed prior to enrollment * Diagnosis of or symptoms concerning for cauda equina syndrome
Contact & Investigator
Don Kim Moore, MD
PRINCIPAL INVESTIGATOR
Missouri Orthopaedic Institute
Frequently Asked Questions
Who can join the NCT04182997 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lumbar Disc Herniation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04182997 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04182997 currently recruiting?
Yes, NCT04182997 is actively recruiting participants. Contact the research team at jonesvicki@health.missouri.edi for enrollment information.
Where is the NCT04182997 trial being conducted?
This trial is being conducted at Columbia, United States.
Who is sponsoring the NCT04182997 clinical trial?
NCT04182997 is sponsored by University of Missouri-Columbia. The principal investigator is Don Kim Moore, MD at Missouri Orthopaedic Institute. The trial plans to enroll 200 participants.