NCT07498140 · Northwestern University
Procedural Framing and Epidural Steroid Injection Outcomes
(PEACE)
What this study is about
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.
View original scientific description
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 participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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)
- 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
- Inability to understand basic English
Where
- Chicago, Illinois
- Bethesda, Maryland
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 25, 2026 · Source of record for eligibility and locations