Procedural Framing and Epidural Steroid Injection Outcomes (NCT07498140)
PEACE Study: Psychophysical Enhancement to Augment Conservative and Epidural Steroid Injection Outcomes: A Multi-Center International Randomized Trial
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Northwestern University — Chicago, Illinois
🧪 Interventions in This Study
- Behavioral manipulation of ESI expectations (BEHAVIORAL)
- No behavioral manipulation of ESI expectations (OTHER)
- No behavioral manipulation of pharmacotherapy expectations (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (4 Sites)
- Northwestern University — Chicago, Illinois
- Walter Reed National Military Medical Center — Bethesda, Maryland
- Phramongkutklao Military Hospital — Bangkok,
- First Lviv Medical Union — Lviv,
📞 Contact the Study Coordinator
Phone: (312) 695-2500
Email: steven.cohen@northwestern.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Lumbosacral Radiculopathy
- A Long-term, 3-Year, Follow-up Study for Patients Completing the KS-GIG-001-01 Study — Salt Lake City, Utah
- A Multicomponent Intervention for Patients With Lumbosacral Radiculopathy: Move-MORE — Portland, Oregon
Explore by condition: All Lumbosacral Radiculopathy clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.