Procedural Framing and Epidural Steroid Injection Outcomes
United States, Thailand, Ukraine210 participantsStarted 2026-03-30
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.