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RECRUITING
NCT07498140
NA

Procedural Framing and Epidural Steroid Injection Outcomes

Sponsor: Northwestern University

View on ClinicalTrials.gov

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, we will conduct a 3-arm randomized trial comparing positive framing of ESI, neutral framing of ESI, and medications, in patients with lumbosacral radiculopathy.

Official title: The Effect of Procedural Framing on Epidural Steroid Injection Outcomes: A Randomized Controlled Study

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

210

Start Date

2026-03-25

Completion Date

2028-06-30

Last Updated

2026-03-27

Healthy Volunteers

No

Interventions

BEHAVIORAL

Behavioral manipulation of ESI expectations

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

OTHER

No behavioral manipulation of ESI expectations

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

OTHER

No behavioral manipulation of pharmacotherapy expectations

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

Locations (2)

Northwestern University

Chicago, Illinois, United States

Walter Reed National Military Medical Center

Bethesda, Maryland, United States