Recruiting

ESI, Medications, Framing

Sponsor:

Northwestern University

Code:

NCT07498140

Conditions

Lumbosacral Radiculopathy

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Behavioral manipulation of ESI expectations

No behavioral manipulation of ESI expectations

No behavioral manipulation of pharmacotherapy expectations

Study Details

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.

Conditions

Lumbosacral Radiculopathy

Study ID

NCT07498140

Start date

Mar 30, 2026

Status verified date

Aug, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Mar 25, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

210 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Positive framing- ESI

Patients will review around 5 slides detailing ESI in a very positive light and references, with study personnel available to answer questions.

placebo comparator: Neutral framing- ESI

Patients will review 1 slide that portrays ESI in a neutral light.

placebo comparator: Pharmacotherapy with gabapentin, nortriptyline and/or duloxetine

Patients will review 1 neutrally-framed slide that portrays adjuvant medications for neuropathic pain in a neutral light.

Interventions

Behavioral manipulation of ESI expectations

5-slide summary of ESI portrayed in a positive light, accompanied by a study investigator.

No behavioral manipulation of ESI expectations

1-slide summary of ESI portrayed in a neutral light.

No behavioral manipulation of pharmacotherapy expectations

1-slide summary of medications for neuropathic pain portrayed in a neutral light.

Primary outcome measure

  • Mean reduction in average leg pain [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Steven P Cohen, MD

312-695-2500steven.cohen@northwestern.edu

Jordan Wood, BS

312-695-2500Jordan.Wood1@northwestern.edu

Locations

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Steven P Cohen, MD

312-695-2500steven.cohen@northwestern.edu

Jordan Wood, BS

3126952500Jordan.Wood1@northwestern.edu

More Information

Sponsor

Northwestern University

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Keywords

  • Back pain
  • Lumbar radiculopathy
  • Epidural steroid injection
  • Placebo effect
  • Sciatica
  • Positive framing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-08-18.