Epidural Steroid Injections for Back Pain
(PROFESS Trial)
What You Need to Know Before You Apply
What is the purpose of 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.
Who Is on the Research Team?
Steven P Cohen, MD
Principal Investigator
Northwestern University Feinberg School of Medicine
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either positive or neutral framing of ESI or pharmacotherapy with instructions to exercise
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Epidural Steroid Injection
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Patients will review around 5 slides detailing ESI in a very positive light and references, with study personnel available to answer questions.
Patients will review 1 slide that portrays ESI in a neutral light.
Patients will review 1 slide that portrays adjuvant medications for neuropathic pain in a neutral light.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwestern University
Lead Sponsor
Phramongkutklao College of Medicine and Hospital
Collaborator
Ramathibodi Hospital
Collaborator
Walter Reed National Military Medical Center
Collaborator
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.