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Epidural Steroids for Slipped Disc (Intra-Op Trial)

Phase 4
Recruiting
Led By Don Kim Moore, MD
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Recent MRI confirming single-level lumbar disc herniation corresponding to clinical evaluation
Failed conservative treatment - rest, anti-inflammatory medications, physical therapy
Must not have
Previous surgery at the affected level or recurrent herniation
Concomitant spinal stenosis, segmental instability, or spondylolisthesis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until final follow up (up to 8 weeks
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial is testing a new way to grade the severity of inflammation in lumbar disc herniation, as well as testing whether or not epidural steroids help patients with this condition.

Who is the study for?
This trial is for individuals with a confirmed single-level lumbar disc herniation, experiencing leg pain or nerve-related symptoms, who haven't improved with rest, anti-inflammatory meds, or physical therapy. It's only for those treated within the University of Missouri hospital system and not for pregnant women, people with certain spine conditions like spinal stenosis or previous surgery at the affected level.
What is being tested?
The study aims to create a grading system for inflammation due to slipped discs and see if injecting steroids into the spine during surgery helps. Participants will receive either saline (a placebo) or Dexamethasone (a steroid) directly into their epidural space during discectomy surgery.
What are the potential side effects?
Dexamethasone may cause side effects such as increased blood sugar levels, mood swings, insomnia, weakened immune response making it easier to get infections and possibly slow wound healing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My recent MRI shows a single-level lumbar disc herniation.
Select...
I have tried rest, anti-inflammatory drugs, and physical therapy without success.
Select...
I am being treated for a slipped disc in my lower back at the University of Missouri hospital system.
Select...
I have nerve pain or weakness in my arms or legs.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had surgery before or a recurring herniation at the same spot.
Select...
I have a narrowed spinal canal or slipped vertebra.
Select...
I have been diagnosed with or am showing signs of cauda equina syndrome.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until final follow up (up to 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and until final follow up (up to 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Post Operative Oswestry Disability Index
Post Operative Pain Scores
Secondary study objectives
Length of stay
Post Operative Complications
Post Operative Opioid Usage

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Dexamethasone GroupActive Control1 Intervention
Patients in this group will be given the study drug (dexamethasone).
Group II: Placebo GroupPlacebo Group1 Intervention
Patients in this group will be given the placebo (sterile saline).

Find a Location

Who is running the clinical trial?

University of Missouri-ColumbiaLead Sponsor
380 Previous Clinical Trials
628,562 Total Patients Enrolled
Don Kim Moore, MDPrincipal InvestigatorMissouri Orthopaedic Institute
1 Previous Clinical Trials

Media Library

Dexamethasone Group Clinical Trial Eligibility Overview. Trial Name: NCT04182997 — Phase 4
Slipped Disc Research Study Groups: Placebo Group, Dexamethasone Group
Slipped Disc Clinical Trial 2023: Dexamethasone Group Highlights & Side Effects. Trial Name: NCT04182997 — Phase 4
Dexamethasone Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT04182997 — Phase 4
~26 spots leftby Oct 2025
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