RecruitingNot ApplicableNCT07498140

Procedural Framing and Epidural Steroid Injection Outcomes

PEACE Study: Psychophysical Enhancement to Augment Conservative and Epidural Steroid Injection Outcomes: A Multi-Center International Randomized Trial


Sponsor

Northwestern University

Enrollment

210 participants

Start Date

Mar 30, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Behavioral manipulation of ESI expectations, No behavioral manipulation of ESI expectations, and others for people with lumbosacral radiculopathy. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALBehavioral manipulation of ESI expectations

5-slide summary of ESI portrayed in a positive light, accompanied by a study investigator.

OTHERNo behavioral manipulation of ESI expectations

1-slide summary of ESI portrayed in a neutral light.

OTHERNo behavioral manipulation of pharmacotherapy expectations

1-slide summary of medications for neuropathic pain portrayed in a neutral light.


Locations(4)

Northwestern University

Chicago, Illinois, United States

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Phramongkutklao Military Hospital

Bangkok, Thailand

First Lviv Medical Union

Lviv, Ukraine

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NCT07498140


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