Treatment effects in pharmacological clinical randomized controlled trials are mainly due to placebo.
Stefan Schmidt, Martin Loef, Thomas Ostermann...
https://pubmed.ncbi.nlm.nih.gov/39733973Actively Recruiting
Phase Not Applicable
All Genders
ID07498140
The Effect of Procedural Framing on Epidural Steroid Injection Outcomes: A Randomized Controlled Study
Led by Northwestern University · Updated on 2026-05-01
210
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
P
Phramongkutklao College of Medicine and Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Back pain is a leading cause of disability worldwide, especially among military personnel. Epidural steroid injections (ESI) are commonly used to manage lumbosacral radiculopathy, a condition causing pain radiating to the lower limbs. This research aims to explore how the way ESI is presented, either positively or neutrally, affects pain relief outcomes compared to medication and exercise. The study is a randomized controlled trial designed to understand the impact of treatment framing on pain.
CONDITIONS
Brief Title
Procedural Framing and Epidural Steroid Injection Outcomes
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years
- Lumbosacral radicular pain confirmed by history and physical exam
- Pain lasting more than 6 weeks
- Leg pain score above 4 on a numeric rating scale or at least equal to back pain if score is 3
- MRI evidence of spinal pathology matching symptoms
- Suitable candidates for epidural steroid injection and medication therapy
You will not qualify if you...
- Untreated bleeding disorder
- Previous spine surgery
- No MRI or MRI does not match symptoms
- Leg pain lasting more than 15 years
- Epidural steroid injection within past 2 years
- Signs or symptoms of cauda equina syndrome
- Previous failed treatment with gabapentin, pregabalin, tricyclic antidepressants, or duloxetine
- Allergic reactions preventing use of contrast dye or study medications
- Referral for diagnostic injections related to surgery evaluation
- Serious medical or untreated psychiatric conditions that may affect outcomes
- Pregnancy
- Inability to understand basic English
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single session at enrollment
Participants receive one of three interventions: a positive framing presentation about epidural steroid injections (ESI) with study personnel available for questions, a neutral framing presentation about ESI, or a neutral presentation about pharmacological therapy and exercise instructions.
1 visit (in-person)
Follow-up
Duration - Up to 12 weeks
Participants are monitored for outcomes including pain levels, patient satisfaction, disability, and medication use for up to 12 weeks after the intervention.
Follow-up assessments at 15 minutes post-procedure and at 4 and 12 weeks
Trial Site Locations
Total: 2 locations
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
2
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20814
Enrolling by Invitation
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Research Team
S
Steven P Cohen, MD
J
Jordan Wood, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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