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Procedural Framing and Epidural Steroid Injection Outcomes
Sponsor: Northwestern University
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
Conditions
Interventions
Behavioral manipulation of ESI expectations
5-slide summary of ESI portrayed in a positive light, accompanied by a study investigator.
No behavioral manipulation of ESI expectations
1-slide summary of ESI portrayed in a neutral light.
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