Procedural Framing and Epidural Steroid Injection Outcomes

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorNorthwestern University

About this trial

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 criteria

Qualifiers

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)

Disqualifiers

Untreated coagulopathy

Previous spine surgery

No MRI or non-concordant MRI study

Leg pain > 15 years duration

Trial design

Treatments tested in this trial

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

Treatment groups

210 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Northwestern University

Lead sponsor

Phramongkutklao College of Medicine and Hospital

Collaborator

Ramathibodi Hospital

Collaborator

Walter Reed National Military Medical Center

Collaborator

First Lviv Medical Union

Collaborator