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
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