150 Participants Needed

Epidural Steroids for Back Pain

RK
MC
Overseen ByMatthew Cunningham, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Hospital for Special Surgery, New York
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This trial tests if applying a steroid during back surgery helps patients recover faster and need less pain medication. It focuses on patients having a specific type of back surgery and looks at their recovery and pain levels.

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.

What data supports the effectiveness of the drug Depo-Medrol 40Mg/Ml Suspension for Injection in treating 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 those receiving another steroid, betamethasone. Additionally, Depo-Medrol was found to provide greater and earlier improvement in patients with chronic sciatica compared to another treatment.12345

Is it safe to use epidural steroids like Depo-Medrol for back pain?

Epidural steroid injections like Depo-Medrol are generally considered safe, with studies showing no side effects in patients treated for back pain. However, rare complications can occur, such as accidental injection into the wrong area, which can lead to serious issues like retinal detachment.12367

How does the drug used in epidural steroid injections for back pain differ from other treatments?

Epidural steroid injections, specifically using methylprednisolone (Depo-Medrol), are unique because they deliver the medication directly into the epidural space around the spinal cord, providing targeted anti-inflammatory effects. This method can offer significant pain relief and improved function, especially in the short term, compared to other steroids like betamethasone, which may not be as effective when administered epidurally.12348

Eligibility Criteria

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.
See 4 more

Timeline

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)

Treatment Details

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).
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 1: Topical SteroidExperimental Treatment1 Intervention
Group II: Group 2: Topical Normal SalinePlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hospital for Special Surgery, New York

Lead Sponsor

Trials
257
Recruited
61,800+

Findings from Research

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.
Comparison of epidural Depo-Medrol vs. aqueous betamethasone in patients with low back pain.Noe, CE., Haynsworth, RF.[2006]
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.
Management of diskogenic pain using epidural and intrathecal steroids.Brown, FW.[2019]
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.
[Epidural injections of steroids in the treatment of patients with chronic sciatica in discopathy].Popiołek, A., Domanik, A., Mazurkiewicz, G.[2018]

References

Comparison of epidural Depo-Medrol vs. aqueous betamethasone in patients with low back pain. [2006]
Management of diskogenic pain using epidural and intrathecal steroids. [2019]
[Epidural injections of steroids in the treatment of patients with chronic sciatica in discopathy]. [2018]
Epidural application of cortico-steroids in low-back pain and sciatica. [2019]
Use of epidural corticosteroids in low back pain. [2017]
Complications associated with epidural steroid injections. [2022]
[Retinal detachment after accidental intra-vitreous Depo-Medrol injection. A case report]. [2018]
Clinical and histological effects of the intrathecal administration of methylprednisolone in dogs. [2013]