200 Participants Needed

Epidural Steroids for Slipped Disc

(Intra-Op Trial)

Recruiting at 1 trial location
SC
VJ
Overseen ByVickci Jones, MEd, CCRP
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are using chronic steroids or immunosuppressive drugs, you may not be eligible to participate.

Is dexamethasone safe for treating slipped discs?

Research shows that dexamethasone, a type of steroid, has been used safely in humans for conditions like slipped discs and ischalgia (a type of nerve pain). While its effectiveness may vary, studies indicate it is generally safe when used in controlled doses.12345

How does the drug used in the trial for slipped disc differ from other treatments?

Epidural steroids, like dexamethasone, are injected directly into the space around the spinal nerves, which can provide quick pain relief by reducing inflammation. This method is different from oral medications or surgery, as it targets the affected area directly and may help avoid surgery in many cases.26789

What evidence supports the effectiveness of the drug dexamethasone for treating a slipped disc?

Research shows that dexamethasone can provide quick pain relief for patients with a herniated lumbar disc, potentially reducing the need for surgery. However, another study found that its effectiveness was similar to a placebo, indicating mixed results.127910

Who Is on the Research Team?

DK

Don Kim Moore, MD

Principal Investigator

Missouri Orthopaedic Institute

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My recent MRI shows a single-level lumbar disc herniation.
I have tried rest, anti-inflammatory drugs, and physical therapy without success.
I am being treated for a slipped disc in my lower back at the University of Missouri hospital system.
See 1 more

Exclusion Criteria

I have had surgery before or a recurring herniation at the same spot.
I have a narrowed spinal canal or slipped vertebra.
Pregnancy - qualitative human chorionic gonadotropin (hCG) testing will be performed prior to enrollment
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo discectomy surgery with intraoperative administration of either dexamethasone or placebo

1 day
1 visit (in-person, surgical procedure)

Follow-up

Participants are monitored for post-operative outcomes including disability index, pain scores, opioid usage, and complications

8 weeks
Multiple visits (in-person and/or virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Dexamethasone
Trial Overview 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.
How Is the Trial Designed?
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 Clinic Near You

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials
387
Recruited
629,000+

Published Research Related to This Trial

In a study involving 73 patients undergoing percutaneous epidural adhesiolysis, dexamethasone sodium phosphate (DSP) demonstrated non-inferiority to triamcinolone acetate (TA) in reducing pain and improving function at the 6-month follow-up, with success rates of 62.5% for DSP compared to 45.2% for TA.
At 3 months, while DSP showed a higher mean percent decrease in pain scores (46.1%) compared to TA (42.4%), non-inferiority was not established until the 6-month mark, indicating that DSP may provide longer-lasting benefits in pain management.
Percutaneous Epidural Adhesiolysis with Epidural Steroid Injection: A Non-inferiority Test of Non-particulate Steroids Versus Particulate Steroids.Cho, S., Park, HS.[2018]
In a double-blind study of 39 patients with prolapsed lumbar disc symptoms, dexamethasone did not show a statistically significant advantage over placebo, with only 19 patients receiving dexamethasone experiencing improvement compared to 20 patients on placebo.
Despite some patients showing improvement, 50% of those who did improve in both groups experienced recurrences of symptoms within 3 months, suggesting that neither treatment provided lasting relief.
Effects of using dexamethasone and placebo in the treatment of prolapsed lumbar disc.Hedeboe, J., Buhl, M., Ramsing, P.[2019]
In a study of 90 patients undergoing major abdominal surgery, administering 5 mg of epidural dexamethasone either before or after the operation significantly reduced postoperative pain and the need for rescue analgesics compared to a control group without dexamethasone.
While there were no significant differences in nausea and vomiting among the groups, patients receiving dexamethasone at the end of the operation reported more frequent itching, indicating a potential side effect to consider.
The effect of epidural administration of dexamethasone on postoperative pain: a randomized controlled study in radical subtotal gastrectomy.Jo, YY., Yoo, JH., Kim, HJ., et al.[2022]

Citations

Percutaneous Epidural Adhesiolysis with Epidural Steroid Injection: A Non-inferiority Test of Non-particulate Steroids Versus Particulate Steroids. [2018]
Effects of using dexamethasone and placebo in the treatment of prolapsed lumbar disc. [2019]
The effect of epidural administration of dexamethasone on postoperative pain: a randomized controlled study in radical subtotal gastrectomy. [2022]
Analgesia after Epidural Dexamethasone is Further Enhanced by IV Dipyrone, but Not IV Parecoxibe Following Minor Orthopedic Surgery. [2021]
Dexamethasone in the management of symptoms due to herniated lumbar disc. [2019]
Lumbar transforaminal epidural dexamethasone: a prospective, randomized, double-blind, dose-response trial. [2022]
Prolapsed lumbar disc treated with intramuscularly administered dexamethasonephosphate. A prospectively planned, double-blind, controlled clinical trial in 52 patients. [2019]
[Assessment of dexamethasone effectiveness in the treatment of ischalgia]. [2015]
Epidural Dexamethasone Influences Postoperative Analgesia after Major Abdominal Surgery. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Serum Triamcinolone Levels following Cervical Interlaminar Epidural Injection. [2018]
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