Procedural Framing and Epidural Steroid Injection Outcomes

Conditions

• Lumbosacral Radiculopathy

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Behavioral manipulation of ESI expectations — BEHAVIORAL
  5-slide summary of ESI portrayed in a positive light, accompanied by a study investigator.
• No behavioral manipulation of ESI expectations — OTHER
  1-slide summary of ESI portrayed in a neutral light.
• No behavioral manipulation of pharmacotherapy expectations — OTHER
  1-slide summary of medications for neuropathic pain portrayed in a neutral light.

Study Details

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.

Key Dates

Start date

Mar 30, 2026

Status verified

Apr 2026

Primary completion

Mar 25, 2028

Completion

Jun 30, 2028

Study Design

Enrollment

210 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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 slide that portrays adjuvant medications for neuropathic pain in a neutral light.

Primary Outcome Measure

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

Central Contacts

• Steven P Cohen, MD
  312-695-2500
  [email protected]
• Jordan Wood, BS
  312-695-2500
  [email protected]

Locations (2)

Find similar trials in Chicago, IL

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