210 Participants NeededMy employer runs this trial

Epidural Steroid Injections for Back Pain

(PEACE Trial)

Recruiting at 3 trial locations
SP
JW
Overseen ByJordan Wood, BS

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different explanations of epidural steroid injections (ESI) affect back pain relief. It compares two groups receiving ESI: one hears a very positive explanation, while the other hears a neutral one. Another group takes medications such as gabapentin, nortriptyline, or duloxetine. This study targets individuals with back pain radiating down their legs, persisting for more than six weeks. Participants should have pain that aligns with MRI scan findings. As an unphased trial, it offers a unique opportunity to understand how communication impacts treatment outcomes.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that epidural steroid injections (ESI) for back pain are generally safe, though some risks exist. Most people tolerate the treatment well. However, serious complications, such as a small risk of paralysis or death, have been reported. These severe outcomes are rare, particularly when the injection targets the lower back, which is the focus here.

In some studies, a few individuals experienced increased pain after the injection or mild allergic reactions. Despite these risks, many report reduced pain following an ESI. This procedure has provided pain relief since 1952, offering a nonsurgical option for those with back pain.

Weighing the potential benefits against the risks is important. Prospective trial participants should discuss these findings with a healthcare provider to make an informed decision.12345

Why are researchers excited about this trial?

Researchers are excited about epidural steroid injections (ESI) for back pain because they offer a targeted approach to reducing inflammation and pain directly at the source. Unlike oral medications like gabapentin or duloxetine, which work systemically and can take time to show effects, ESIs deliver corticosteroids right into the epidural space around the spine, potentially offering quicker relief. This direct delivery might help patients experience less overall pain and improve mobility faster. Additionally, ESIs could provide an option for those who haven't had success with standard pain management treatments.

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

This trial will evaluate different methods of presenting information about epidural steroid injections (ESIs) for back pain. Studies have shown that ESIs can effectively relieve back pain, particularly in the short to medium term. Research indicates that patients with sciatica, characterized by pain traveling down the legs from the lower back due to lumbar disc issues, often experience significant relief after an ESI. In some cases, up to 79% of patients reported a substantial and lasting reduction in pain. However, the benefits may decrease after about five months and appear less effective for long-term chronic back pain lasting over a year. Overall, ESIs often provide more immediate relief compared to other conservative treatments.678910

Who Is on the Research Team?

SP

Steven P Cohen, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with back pain radiating to the legs (sciatica or similar), confirmed by MRI, lasting more than 6 weeks, and who are candidates for both epidural steroid injections and medications. People can't join if they've had certain prior treatments fail, recent spine surgery or injection, severe allergies to study drugs, serious health issues, or can't understand English.

Inclusion Criteria

MRI evidence of spinal pathology consistent with symptoms
I am over 18 years old.
I have lower back pain that radiates down one or both legs.
See 3 more

Exclusion Criteria

I have had leg pain for more than 15 years.
No MRI or non-concordant MRI study
I have tried and not improved with gabapentin, pregabalin, tricyclics, and duloxetine.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either positive or neutral framing of ESI or pharmacotherapy with instructions to exercise

4 weeks
1 visit (in-person) for procedure and follow-up

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks
Regular assessments for pain and satisfaction

What Are the Treatments Tested in This Trial?

Interventions

  • Epidural Steroid Injection

Trial Overview

The study compares three groups: one gets an epidural steroid injection described in a very positive way; another gets the same injection but described neutrally; the third group receives medication only. Participants are randomly assigned to these groups.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: Positive framing- ESIExperimental Treatment1 Intervention
Group II: Pharmacotherapy with gabapentin, nortriptyline and/or duloxetinePlacebo Group1 Intervention
Group III: Neutral framing- ESIPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

Phramongkutklao College of Medicine and Hospital

Collaborator

Trials
39
Recruited
7,900+

Ramathibodi Hospital

Collaborator

Trials
74
Recruited
35,100+

Walter Reed National Military Medical Center

Collaborator

Trials
149
Recruited
33,800+

First Lviv Medical Union

Collaborator

Citations

Efficacy of epidural steroid injection in the treatment of sciatica ...

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

Evaluating the Effectiveness of Epidural Steroid Injections in ...

The data provides some evidence that ESIs are most reliable at relieving pain up to the five-month mark, after which their efficacy decreases.

Effectiveness of Epidural Steroid Injections for Low Back Pain

Epidural steroid injection has minimal benefit for patients with chronic (12 months or longer) low back pain. (SOR: A, meta-analysis of RCTs.) Evidence Summary.

Therapeutic Effect and Outcome Predictors of Sciatica Treated ...

In total, 22 (79%) of the 28 patients experienced a substantial, permanent reduction in pain. Narozny et al. [31] reported that transforaminal epidural steroid ...

Systematic review of the effectiveness of caudal epidural ...

The primary outcome was the proportion of individuals with reduction of pain by ​≥ ​50%. Secondary outcomes included functional improvement, analgesic use, ...

Safety of Epidural Steroid Injections for Lumbosacral ... - PMC

Although effective in certain patient populations, ESIs have been associated with serious complications, including paralysis and death.

Safety of Epidural Corticosteroid Injections - PMC - NIH

ESIs are relatively safe; however, although major complications of ESIs have been reported, their true incidence remains obscure.

Epidural steroid injections in lumbar disc herniation

The results showed that epidural steroids after PELD might reduce back and leg pain while improving functional outcomes in the short-term postoperative period ( ...

Effectiveness of epidural steroid injections for low back pain in ...

Two [29, 33] studies reported increased pain after epidural steroid injection. One [33] study reported two patients with mild allergic reactions ...

Epidural Steroid Injections for Chronic Back Pain: An AAN ...

When compared to people not receiving the treatment, 24% more people receiving the treatment reported reduced pain, and 16% more reported ...