How the way doctors explain epidural steroid injections affects sciatica pain outcomes
The Effect of Procedural Framing on Epidural Steroid Injection Outcomes: A Randomized Controlled Study
NA · Northwestern University · NCT07498140
This trial will test whether explaining epidural steroid injections more positively or more neutrally changes pain for adults with lumbosacral radiculopathy who are candidates for injections.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Sex | All |
| Sponsor | Northwestern University (other) |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Trial ID | NCT07498140 on ClinicalTrials.gov |
What this trial studies
Two hundred ten adults with MRI-confirmed lumbosacral radiculopathy and moderate-to-severe leg pain will be randomized in a 2:2:1 ratio to positive framing for epidural steroid injection (ESI), neutral framing for ESI, or a pharmacotherapy plus exercise active control. Randomization is blocked in groups of 10 and suballocated by unilateral versus bilateral symptoms to match injection type (transforaminal vs interlaminar). The positive framing arm receives a brief slide presentation summarizing evidence and guidelines that present ESI more favorably, while the neutral arm receives more neutral information; an investigator is available to answer questions. Pain and related outcome measures will be compared across groups to see whether expectation framing changes the effectiveness of ESI.
Who should consider this trial
Good fit: Adults over 18 with MRI-confirmed lumbosacral radiculopathy for more than 6 weeks, moderate-to-severe leg pain, and who are candidates for epidural steroid injection or pharmacotherapy are ideal.
Not a fit: Patients with prior spine surgery, recent epidural steroid injection (within 2 years), very long-standing leg pain (>15 years), untreated coagulopathy, signs of cauda equina syndrome, allergies or contraindications to contrast or the study medications, or prior failure of key neuropathic pain drugs are excluded and unlikely to benefit.
Why it matters
Potential benefit: If successful, changing how clinicians present epidural injections could reduce pain and improve function without altering the procedure or medications.
How similar studies have performed: Prior research shows strong placebo and expectation effects for pain treatments and some evidence that procedural framing can influence outcomes, but randomized trials specifically testing framing for epidural steroid injections are limited.
Eligibility criteria
Show full inclusion / exclusion 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) * 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
Where this trial is running
Chicago, Illinois and 1 other locations
- Northwestern University — Chicago, Illinois, United States (RECRUITING)
- Walter Reed National Military Medical Center — Bethesda, Maryland, United States (ENROLLING_BY_INVITATION)
Study contacts
- Principal investigator: Steven P Cohen, MD — Northwestern University Feinberg School of Medicine
- Study coordinator: Steven P Cohen, MD
- Email: steven.cohen@northwestern.edu
- Phone: 312-695-2500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lumbosacral Radiculopathy, Back pain, Lumbar radiculopathy, Epidural steroid injection, Placebo effect, Sciatica, Positive framing