Clinical Trial

Procedural Framing and Epidural Steroid Injection Outcomes

Study acronym: PEACE
Recruiting
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Summary
Back pain is the leading cause of disability and military medical boards across the globe. Epidural steroid injections (ESI) are the most commonly performed pain procedure in the world. There is strong evidence that the placebo effect for all pain treatments, including ESI, is greater than the intrinsic effect. The placebo effect is highly dependent on a patient's 'expectations', and therefore how the procedure is framed. This study aims to compare ESI when the procedure is framed very positively- as is often done in clinical practice vs. more neutrally (which is less commonly done in clinical practice but consistent with evidence). The placebo effect is also stronger for procedures than medications. The evidence on the benefits of ESI is highly dependent on whether it is compiled by interventional doctors who perform the procedure or non-interventional researchers. In order to determine how 'framing' a treatment affects pain outcomes, the investigative team will conduct a 3-arm randomized trial comparing positive framing of ESI, neutral framing of ESI, and medications, in patients with lumbosacral radiculopathy.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2026-03-23; most recent amendment 2026-06-22.
Trial Details
NCT Number NCT07498140
Lead Sponsor Northwestern University
Collaborators: Phramongkutklao College of Medicine and Hospital, Ramathibodi Hospital, Walter Reed National Military Medical Center, First Lviv Medical Union
Conditions Lumbosacral Radiculopathy
Enrollment 210 participants
Start Date 2026-03-30
Primary Completion 2028-03-25 (estimated)
Study Completion 2028-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-25