Epidural Steroids for Slipped Disc

(Intra-Op Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Don Kim Moore, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: University of Missouri-Columbia

Must not be taking: Chronic steroids, Immunosuppressants

Disqualifiers: Spinal stenosis, Segmental instability, Spondylolisthesis, Immunocompromise, Pregnancy, others

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 2 6 7 8}

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. ^{1 3 5 9 10}

Research Team

Don Kim Moore, MD

Principal Investigator

Missouri Orthopaedic Institute

Eligibility Criteria

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.

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

Trial Timeline

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)

Treatment Details

Interventions

• Dexamethasone (Corticosteroid)

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.

Participant Groups

Group I: Dexamethasone Group Active Control 1 Intervention

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

Group II: Placebo Group Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

Mun Y. Choi

University of Missouri-Columbia

Chief Executive Officer since 2017

PhD in Mechanical and Aerospace Engineering from Princeton University

Richard Barohn

University of Missouri-Columbia

Chief Medical Officer since 2020

MD from the University of Missouri-Columbia School of Medicine

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Epidural administration of dexamethasone provided effective pain relief after minor orthopedic surgery, lasting about 7 hours, and reduced the need for additional painkillers compared to the control group.

Combining epidural dexamethasone with IV dipyrone significantly extended pain relief to 17 hours and decreased overall painkiller consumption, while adding IV parecoxibe did not enhance the analgesic effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesia after Epidural Dexamethasone is Further Enhanced by IV Dipyrone, but Not IV Parecoxibe Following Minor Orthopedic Surgery. Lauretti, GR., Righeti, CC., Kitayama, AT.[2021]

In a study of 43 patients with acute ischalgia due to intervertebral disc disease, dexamethasone was found to be effective and safe when administered in high but rapidly decreasing doses.

The results indicated that dexamethasone provided better outcomes compared to tramadol for treating ischalgia, suggesting it may be a preferable treatment option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Assessment of dexamethasone effectiveness in the treatment of ischalgia]. Kwasucki, J., Olbrych-Karpińska, B., Stepień, A., et al.[2015]

The study analyzed the pharmacokinetics of triamcinolone acetonide after cervical epidural steroid injections in eight patients, revealing a long terminal elimination half-life of 219 hours, indicating prolonged presence in the system.

Peak serum concentrations of triamcinolone were observed at 5.4 ng/mL approximately 22.1 hours post-injection, suggesting that while the drug is absorbed systemically, its elimination is faster compared to lumbar epidural injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serum Triamcinolone Levels following Cervical Interlaminar Epidural Injection. Lamer, TJ., Dickson, RR., Gazelka, HM., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Percutaneous Epidural Adhesiolysis with Epidural Steroid Injection: A Non-inferiority Test of Non-particulate Steroids Versus Particulate Steroids. [2018]

2. Denmark pubmed.ncbi.nlm.nih.gov

Effects of using dexamethasone and placebo in the treatment of prolapsed lumbar disc. [2019]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

The effect of epidural administration of dexamethasone on postoperative pain: a randomized controlled study in radical subtotal gastrectomy. [2022]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Analgesia after Epidural Dexamethasone is Further Enhanced by IV Dipyrone, but Not IV Parecoxibe Following Minor Orthopedic Surgery. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Dexamethasone in the management of symptoms due to herniated lumbar disc. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Lumbar transforaminal epidural dexamethasone: a prospective, randomized, double-blind, dose-response trial. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Prolapsed lumbar disc treated with intramuscularly administered dexamethasonephosphate. A prospectively planned, double-blind, controlled clinical trial in 52 patients. [2019]

8. Poland pubmed.ncbi.nlm.nih.gov

[Assessment of dexamethasone effectiveness in the treatment of ischalgia]. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

Epidural Dexamethasone Influences Postoperative Analgesia after Major Abdominal Surgery. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Serum Triamcinolone Levels following Cervical Interlaminar Epidural Injection. [2018]