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The Effect of Procedural Framing on Epidural Steroid Injection Outcomes: A Randomized Controlled Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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

Locations
United States
Illinois
Northwestern University
RECRUITING
Chicago
Maryland
Walter Reed National Military Medical Center
ENROLLING_BY_INVITATION
Bethesda
Contact Information
Primary
Steven P Cohen, MD
steven.cohen@northwestern.edu
312-695-2500
Backup
Jordan Wood, BS
Jordan.Wood1@northwestern.edu
312-695-2500
Time Frame
Start Date: 2026-03-25
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 210
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Phramongkutklao College of Medicine and Hospital, Ramathibodi Hospital, Walter Reed National Military Medical Center
Leads: Northwestern University

This content was sourced from clinicaltrials.gov