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Procedural Framing and Epidural Steroid Injection Outcomes

RecruitingNAAges any - anyAllNorthwestern University
NCT07498140 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 determ

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📋 Eligibility rules (as published)
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
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What it tests

  • Behavioral manipulation of ESI expectations
  • No behavioral manipulation of ESI expectations
  • No behavioral manipulation of pharmacotherapy expectations
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Where

4 sites
Northwestern University
Chicago, United States
Walter Reed National Military Medical Center
Bethesda, United States
Phramongkutklao Military Hospital
Bangkok, Thailand
First Lviv Medical Union
Lviv, Ukraine
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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