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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

Who can join

All ages · All sexes

Inclusion Criteria:

* Age \> 18
* Lumbosacral radicular pain based on history and physical exam (e.g. pain radiating into one or both lower extremities, sensory loss, muscle weakness, positive straight leg raising test etc.)
* Duration of pain \>6 weeks
* NRS leg pain score \>/= 4 (or if 3/10, greater or equal to back pain \& worst leg pain is \>/=4)
* MRI evidence of spinal pathology consistent with symptoms
* Candidates for ESI and pharmacotherapy

Exclusion Criteria:

* Untreated coagulopathy
* Previous spine surgery
* No MRI or non-concordant MRI study
* Leg pain \> 15 years duration
* Epidural steroid injection within past 2 years
* Signs or symptoms of cauda equina syndrome
* Previous failed trials with gabapentin and pregabalin and tricyclic antidepressants and duloxetine
* Allergic reactions to contrast dye prohibiting injection (e.g., tranforaminal ESI), gabapentinoids, tricyclic antidepressants or duloxetine, and contraindications to all of the above medications
* Referrals from surgery for diagnostic injections for surgical evaluation
* Serious medical (e.g. congestive heart failure) or psychiatric (untreated depression) condition that might preclude optimal outcome
* Pregnancy
* Inability to understand basic English

About the study

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.

What is being tested

• Behavioral manipulation of ESI expectations (behavioral)
• No behavioral manipulation of ESI expectations (other)
• No behavioral manipulation of pharmacotherapy expectations (other)

Sponsor: Northwestern University · Participants: 210 · Started: Mar 30, 2026

Contact the study team

• Steven P Cohen, MD · Phone: 312-695-2500
• Jordan Wood, BS · Phone: 312-695-2500

Official record on ClinicalTrials.gov — NCT07498140

Locations in the U.S.

Conditions

• Back Pain
• Radiculopathy

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.