NCT07498140 Procedural Framing and Epidural Steroid Injection Outcomes
| NCT ID | NCT07498140 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northwestern University |
| Condition | Lumbosacral Radiculopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 210 participants |
| Start Date | 2026-03-30 |
| Primary Completion | 2028-03-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 210 participants in total. It began in 2026-03-30 with a primary completion date of 2028-03-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Steven P Cohen, MD
PRINCIPAL INVESTIGATOR
Northwestern University
Frequently Asked Questions
Who can join the NCT07498140 clinical trial?
This trial is open to participants of all sexes, studying Lumbosacral Radiculopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07498140 currently recruiting?
Yes, NCT07498140 is actively recruiting participants. Contact the research team at steven.cohen@northwestern.edu for enrollment information.
Where is the NCT07498140 trial being conducted?
This trial is being conducted at Chicago, United States, Bethesda, United States, Bangkok, Thailand, Lviv, Ukraine.
Who is sponsoring the NCT07498140 clinical trial?
NCT07498140 is sponsored by Northwestern University. The principal investigator is Steven P Cohen, MD at Northwestern University. The trial plans to enroll 210 participants.