Epidural Steroids for Slipped Disc

(Intra-Op Trial)

Recruiting at 1 trial location

Overseen By Vickci Jones, MEd, CCRP

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Missouri-Columbia

Must not be taking: Chronic steroids, Immunosuppressants

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well an epidural steroid called dexamethasone aids people with a slipped disc in their lower back. The goal is to identify which patients benefit most by comparing it to a placebo (a harmless substance with no active drug). Candidates include those with a slipped disc confirmed by MRI, who have tried other treatments like rest or physical therapy without success, and who experience nerve issues like numbness or weakness. Participants will receive either the steroid or a placebo during surgery to assess if the steroid reduces inflammation and improves outcomes. As a Phase 4 trial, this research aims to understand how this already FDA-approved and effective treatment can benefit more patients.

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 is the safety track record for Dexamethasone?

Research has raised safety concerns about using dexamethasone as an epidural steroid injection. While helpful for certain conditions, studies have linked these injections to serious complications, including paralysis and even death, though such severe outcomes are rare.

Most patients have tolerated dexamethasone well, but side effects remain a risk. For instance, in one case, an injection accidentally entered an artery, potentially leading to more serious problems.

Despite these risks, dexamethasone is often used because it can alleviate issues like sciatica, which causes leg pain due to slipped discs. Participants in the trial should be aware of these safety concerns and discuss them with their healthcare provider. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike traditional treatments for a slipped disc, such as physical therapy, pain relievers, or surgery, dexamethasone offers a unique approach by directly delivering steroids via epidural injection to reduce inflammation and pain precisely at the source. This targeted delivery method allows for potentially quicker relief compared to oral medications that take longer to circulate through the body. Researchers are excited about dexamethasone because it could offer a non-surgical option that provides rapid pain relief and improved mobility, making it a promising alternative for those who haven't found success with other treatments.

What evidence suggests that this trial's treatments could be effective for a slipped disc?

Research has shown that dexamethasone, which trial participants may receive, can aid in treating slipped discs. Studies have found it significantly improves muscle control issues. In one study, dexamethasone reduced the need for surgery by about 30% compared to other treatments. Another study found no major differences in using dexamethasone for lower back pain, yet it still had positive effects. Overall, dexamethasone is considered a helpful and safe option for treating conditions like a slipped disc. Participants in this trial will be randomized to receive either dexamethasone or a placebo. ^{5 6 7 8 9}

Who Is on the Research Team?

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.

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

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?

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+

Published Research Related to This Trial

A study involving 98 subjects found that transforaminal epidural dexamethasone significantly reduced radicular pain by an average of 41.7% at 4 weeks, with continued improvement observed at 8 and 12 weeks, indicating its efficacy in pain management.

No serious adverse events were reported, suggesting that dexamethasone is a safe alternative for epidural steroid injections, and the optimal effective dose may be lower than 4 mg, enhancing its safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lumbar transforaminal epidural dexamethasone: a prospective, randomized, double-blind, dose-response trial. Ahadian, FM., McGreevy, K., Schulteis, G.[2022]

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]

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]

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]

In a study of 100 patients with radicular pain from herniated lumbar discs, treatment with tapering doses of intramuscular dexamethasone resulted in pain relief for all patients within 24-48 hours.

The findings suggest that dexamethasone effectively reduces nerve root inflammation, providing prompt pain relief and potentially reducing the need for surgery, as non-surgically treated patients had better outcomes during a 15-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of using dexamethasone and placebo in the treatment of prolapsed lumbar disc. Hedeboe, J., Buhl, M., Ramsing, P.[2019]

Epidural administration of dexamethasone significantly reduces postoperative pain after major abdominal surgery, with a 10 mg dose being more effective than a 5 mg dose, as shown in a study involving 120 patients undergoing gastrectomy.

Patients receiving the higher dose of dexamethasone (10 mg) reported lower pain levels and required less fentanyl for pain management compared to those receiving saline or the lower dose, without an increase in adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural Dexamethasone Influences Postoperative Analgesia after Major Abdominal Surgery. Hong, JM., Kim, KH., Lee, HJ., et al.[2018]

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 double-blind study involving 52 patients with symptoms from a prolapsed lumbar disc, dexamethasone phosphate did not show any significant effect on pain or other neurological symptoms compared to placebo.

There was no difference in hospitalization length between the dexamethasone phosphate group and the placebo group, suggesting that this treatment may not be effective for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11132404/

Retrospective study assessing the efficacy of i.v. ... However, clinical improvement was significantly better in both the dexamethasone and SNRB groups than in the control group. Motor deficits ...

2. journals.lww.com journals.lww.com/md-journal/fulltext/2022/07150/retrospective_study_assessing_the_efficacy_of_i_v_.43.aspx

Retrospective study assessing the efficacy of i.v.... Motor deficits improved significantly after dexamethasone treatment alone. Dexamethasone and SNRB are useful and safe treatment options for ...

3. nature.com nature.com/articles/s41598-022-10659-1

Effectiveness of intra-venous steroids for preventing ... Intravenous steroid treatment in our retrospective series was approximately 30% better at preventing the need for surgery than the reported outcomes of ...

4. academic.oup.com academic.oup.com/painmedicine/article/15/4/548/1930062

Comparative Effectiveness of Lumbar Transforaminal Epidural ... This study demonstrates that dexamethasone via a transforaminal epidural injection may not have major differences in effectiveness for lumbar radicular pain due ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT00516009

Efficacy of Intravenous Dexamethasone for Acute Disc ... It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3401142/

The Impact of Epidural Steroid Injections on the Outcomes ... Patients with lumbar disc herniation treated with epidural steroid injection had no improvement in short or long-term outcomes compared with patients who were ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8360670/

Safety of Epidural Steroid Injections for Lumbosacral ... Although effective in certain patient populations, ESIs have been associated with serious complications, including paralysis and death.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2772594423000663

Safety of dexamethasone in transforaminal epidural steroid ... This case report describes a very fortunate outcome in which an injection of dexamethasone with lidocaine entered a radiculomedullary artery and caused only ...

9. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1406504/full

Efficacy of epidural steroid injection in the treatment ... Epidural steroid injection has demonstrated notable efficacy in relieving sciatica caused by lumbar disc herniation in short to medium-term.