How the way doctors explain epidural steroid injections affects sciatica pain outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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

Where it's running

• Northwestern University
  Chicago, Illinois, United States Recruiting
• Phramongkutklao Military Hospital
  Bangkok, Thailand Recruiting
• Walter Reed National Military Medical Center
  Bethesda, Maryland, United States Enrolling by invitation
• First Lviv Medical Union
  Lviv, Ukraine Not yet recruiting

Study contacts

• Principal investigator: Steven P Cohen, MD — Northwestern University
• Study coordinator: Steven P Cohen, MD
• Email: steven.cohen@northwestern.edu
• Phone: 312-695-2500

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• VER-01 for chronic painful lumbosacral radiculopathy

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.