Epidural Steroids for Back Pain

Overseen By Matthew Cunningham, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Hospital for Special Surgery, New York

Must not be taking: Opioids, Steroids

Disqualifiers: Chronic pain, Uncontrolled diabetes, Cancer, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 3

Duration: During surgery

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether using a steroid (Depo-Medrol) during back surgery can reduce pain and minimize the need for opioids afterward. It focuses on patients undergoing a specific type of back surgery called a lumbar laminectomy. Participants will receive either the steroid or a placebo (a treatment with no active drug) to determine which is more effective. Those undergoing this surgery without other complex procedures and without a history of daily opioid use might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on chronic steroid therapy or immunosuppressants, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using Depo-Medrol for epidural steroid injections carries serious risks, such as paralysis or even death. Although these risks are rare, they remain possible. The safety of using corticosteroids, like Depo-Medrol, in the spine has not been clearly established, and the FDA has not officially approved it for this use. However, many patients have used these injections for other conditions without major problems. Potential benefits and risks should always be considered before joining a trial like this one. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for back pain?

Most treatments for back pain, like NSAIDs and physical therapy, focus on reducing inflammation or improving mobility over time. But Depo-Medrol, an epidural steroid injection, operates differently by delivering a potent anti-inflammatory effect directly to the affected area, which can lead to quicker pain relief. Researchers are excited about this treatment because it targets inflammation right at the source, which could mean faster and potentially more effective relief compared to traditional systemic treatments. Additionally, this method of delivery minimizes the systemic side effects often seen with oral medications.

What evidence suggests that this trial's treatments could be effective for back pain?

Research has shown that Depo-Medrol injections can effectively reduce pain and disability in people with low back pain. Patients reported significant improvement four weeks after treatment. Another study found that many patients experienced good pain relief following these injections. This treatment reduces swelling, which can help lessen pain. In this trial, participants will receive either Depo-Medrol or a placebo to evaluate its effectiveness. Overall, studies support Depo-Medrol's effectiveness for back pain relief. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 undergoing a specific back surgery called lumbar laminectomy. It's not for those who don't speak English, have had daily opioid use in the last six months, need additional spine procedures, have chronic pain conditions, uncontrolled diabetes (A1C > 6.5), weakened immune systems, prostate issues causing urinary problems or are allergic to Depo-Medrol and steroids.

Inclusion Criteria

I am scheduled for a surgery to remove part of one or two vertebrae.

Exclusion Criteria

Your diabetes is not well controlled, with an A1C level higher than 6.5.

You are allergic to Depo-Medrol, glucocorticoids, or other steroids.

You have used opioid medication daily in the past 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 1-2 level lumbar laminectomy with either 40 mg Depo-Medrol or 1 mL of sterile normal saline applied to the surgical wound

During surgery

1 visit (in-person)

Post-operative Monitoring

Participants are assessed daily for two weeks post-operatively for opioid usage and other outcomes

2 weeks

Daily assessments (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness, including pain and return to work, at 1 and 3 months post-operation

3 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Depo-Medrol 40Mg/Ml Suspension for Injection
• Placebo

Trial Overview The study tests if applying Depo-Medrol steroid directly to the spinal area during surgery can reduce post-surgery opioid use and improve recovery outcomes like hospital stay duration and return-to-work time compared to a placebo (no active medication).

How Is the Trial Designed?

Group I: Group 1: Topical Steroid Experimental Treatment 1 Intervention

Group II: Group 2: Topical Normal Saline Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Hospital for Special Surgery, New York

Lead Sponsor

Trials

257

Recruited

61,800+

Published Research Related to This Trial

In a study of 16 patients with chronic lumbar pain and sciatica, only 62% reported significant pain relief the day after receiving an epidural steroid injection, but this dropped to 43% after one month, indicating limited long-term efficacy.

The results suggest that epidural steroid injections may be ineffective for patients with long-lasting pain and previous disc surgeries, leading to the abandonment of a planned larger randomized trial due to these discouraging findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural application of cortico-steroids in low-back pain and sciatica. Andersen, KH., Mosdal, C.[2019]

Methylprednisolone acetate (Depo-Medrol) injections via epidural or intrathecal routes can effectively relieve diskogenic back pain and radiculopathy when conservative treatments have failed, particularly if symptoms have lasted less than three months.

Corticosteroid injections are less effective for patients with chronic symptoms lasting over three months or those who have previously undergone surgery, suggesting a limited window for optimal use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of diskogenic pain using epidural and intrathecal steroids. Brown, FW.[2019]

Accidental injection of Depo-Medrol into the vitreous cavity can lead to severe complications like retinal detachment, as seen in a case involving a 34-year-old woman treated for anterior uveitis.

Early surgical intervention, including vitrectomy and other techniques, was successful in reattaching the retina and achieving good functional outcomes, highlighting the importance of prompt treatment in such cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Retinal detachment after accidental intra-vitreous Depo-Medrol injection. A case report]. Philips, RH., Kulesza, M.[2018]

The literature review found only a few reports of serious complications from epidural steroid injections, suggesting that they are generally safe when performed correctly.

Most reported complications, such as meningitis and abscesses, were associated with multiple subarachnoid injections, indicating that the risk may increase with the number of procedures rather than being a common outcome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications associated with epidural steroid injections. Abram, SE., O'Connor, TC.[2022]

In a study comparing epidural methylprednisolone (Depo-Medrol) to non-depo betamethasone in patients with low back pain, those receiving Depo-Medrol experienced significant reductions in pain and disability after 4 weeks, while betamethasone showed no significant benefits.

The findings suggest that depo-steroids like methylprednisolone may have superior anti-inflammatory effects compared to non-depo steroids like betamethasone, highlighting the importance of steroid type in epidural injections for effective pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of epidural Depo-Medrol vs. aqueous betamethasone in patients with low back pain. Noe, CE., Haynsworth, RF.[2006]

In a study involving 14 dogs, the injection of methylprednisolone into the intrathecal space resulted in significant histological changes in the spinal cord, including meningeal thickening and lymphocytic infiltrates, despite no observable clinical symptoms during the 21-day evaluation period.

Three dogs developed adhesions between the layers of the meninges, and one dog showed necrosis of the spinal cord, highlighting potential serious complications associated with intrathecal methylprednisolone injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and histological effects of the intrathecal administration of methylprednisolone in dogs. Lima, RM., Navarro, LH., Carness, JM., et al.[2013]

In a study of 30 patients with lumbar discopathy and chronic ischialgia, those receiving epidural steroid injections (Depo-Medrol or Polcortolon) showed greater and earlier improvement compared to a control group that did not receive injections.

Depo-Medrol was more effective than Polcortolon, and importantly, no side effects were reported from the injections, indicating a safe treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Epidural injections of steroids in the treatment of patients with chronic sciatica in discopathy]. Popiołek, A., Domanik, A., Mazurkiewicz, G.[2018]

Epidural corticosteroid injections may effectively relieve low back pain (LBP), particularly in patients who have not responded to conservative treatments, as they target inflammation and nerve root compression directly.

While there are concerns about potential adverse reactions due to preservatives in corticosteroid preparations, the overall safety profile suggests they do not cause significant neurotoxicities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of epidural corticosteroids in low back pain. Tonkovich-Quaranta, LA., Winkler, SR.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2903111/

Local application of low-dose Depo-Medrol is effective in ... Results show that local application of low-dose Depo-Medrol is helpful in reducing immediate postoperative backache after discectomy, but it is not effective ...

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

Safety of Epidural Steroid Injections for Lumbosacral ... This review summarizes the data on the neurological safety issues surrounding ESIs as well as data supporting the efficacy of corticosteroid injections for the ...

3. withpower.com withpower.com/trial/phase-3-spinal-stenosis-8-2021-4c7cb

Epidural Steroids for Back Pain Research shows that patients receiving Depo-Medrol injections for low back pain reported significant pain and disability reduction after 4 weeks compared to ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2214751920300657

Efficacy of Transforaminal epidural steroid injection in ... Overall 56 patients (94.90%) had a satisfactory pain relief after one or two attempts of TFESI and their 1 year follow up pain status after the latest TFESI is ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01397552

Dexamethasone Versus Depo Medrol in Lumbar Epidurals Depo-Medrol is a synthetic steroid (cortisone) medication which also acts as an anti-inflammatory when physicians administer an epidural for relief of low back ...

6. medsafe.govt.nz medsafe.govt.nz/profs/datasheet/d/depomedrolinj.pdf

Depo-Medrol® 40 mg/mL Suspension for Injection Many patients can be controlled with 40 mg of Depo-Medrol sterile aqueous suspension administered in from 30-300 mL of water depending upon the degree of ...

7. healthy.kaiserpermanente.org healthy.kaiserpermanente.org/health-wellness/drug-encyclopedia/drug.depo-medrol-40-mg-ml-suspension-for-injection.165381

Depo-Medrol 40 mg/mL suspension for injection Rare but serious side effects may occur with epidural use. Methylprednisolone is a corticosteroid hormone. Methylprednisolone may also be used with other ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2024/011757s125lbl.pdf

DEPO-MEDROL® (methylprednisolone acetate injectable ... The safety and effectiveness of epidural administration of corticosteroids have not been established, and corticosteroids are not approved for this use ...

9. mayoclinic.org mayoclinic.org/drugs-supplements/methylprednisolone-injection-route/description/drg-20075216

Methylprednisolone (injection route) - Side effects & uses It is used to treat a number of different conditions, such as inflammation (swelling), severe allergies, adrenal problems, arthritis, blood or ...