Recruiting

Epidural Steroid

Sponsor:

University of Missouri-Columbia

Code:

NCT04182997

Conditions

Lumbar Disc Herniation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dexamethasone

saline 0.9%

Study Details

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.

Conditions

Lumbar Disc Herniation

Study ID

NCT04182997

Start date

Nov 21, 2019

Status verified date

May, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo Group

Patients in this group will be given the placebo (sterile saline).

active comparator: Dexamethasone Group

Patients in this group will be given the study drug (dexamethasone).

Interventions

Dexamethasone

Patients included in the treatment group will have their surgical site lavaged with dexamethasone at the end of their surgery.

saline 0.9%

Patients included in the placebo group will have their surgical site lavaged with sterile saline at the end of their surgery.

Primary outcome measure

  • Post Operative Pain Scores [ Time Frame: Until final follow up (up to 8 weeks) ]
  • Post Operative Oswestry Disability Index [ Time Frame: Until final follow up (up to 8 weeks ]

Central Contacts and Locations

Central contacts

Vickci Jones, MEd, CCRP

(573) 882-7583jonesvicki@health.missouri.edi

Locations

Missouri Orthopaedic Institute

Recruiting

Columbia, Missouri, United States, 65202

Contacts

Vicki Jones, MEd,CCRP

573-882-7583jonesvicki@health.missouri.edi

Principal Investigator:

Don Moore, MD

More Information

Sponsor

University of Missouri-Columbia

Last update posted

Jun 3, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Missouri-Columbia on 2026-06-03.