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Procedural Framing and Epidural Steroid Injection Outcomes

NCT07498140 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2026-05-01

No results posted yet for this study

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.

Conditions

  • Lumbosacral Radiculopathy

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.

Sponsors & Collaborators

  • Phramongkutklao College of Medicine and Hospital

    collaborator OTHER

  • Ramathibodi Hospital

    collaborator OTHER

  • Walter Reed National Military Medical Center

    collaborator FED

  • Northwestern University

    lead OTHER

Principal Investigators

  • Steven P Cohen, MD · Northwestern University Feinberg School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-30
Primary Completion
2028-03-25
Completion
2028-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07498140 on ClinicalTrials.gov