Actively Recruiting
Endogenous Opioid Response to Injections
Led by Middle Tennessee Research Institute · Updated on 2025-05-18
33
Participants Needed
1
Research Sites
75 weeks
Total Duration
On this page
Sponsors
M
Middle Tennessee Research Institute
Lead Sponsor
I
International Pain and Spine Intervention Society
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study will study pain relief after spine injections that are used to guide care. Some improvements in pain from a procedure might be from placebo effect rather than the physiological effect of the procedure. The study will use naloxone to reverse the effect of the body's internal placebo system after a spine injection, so the placebo effect and the injection effect can be measured separately. This process may improve the understanding of spine injections and their ability to guide pain care.
CONDITIONS
Official Title
Endogenous Opioid Response to Injections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and consent in English and follow study procedures
- Low back pain lasting 3 months or more despite conventional treatments like physical therapy and medications
- Average low back pain intensity of 4 or higher on a 0-10 scale over 7 days and at the time of lumbar medial branch block
You will not qualify if you...
- Daily opioid or recreational drug use, or opioid use within 3 days before the study
- Positive opioid drug screen on naloxone administration day
- Allergy to naloxone
- Refusal or failure to place an IV
- Previous lumbar medial branch block or radiofrequency neurotomy
- Spine conditions affecting diagnosis or treatment of facet pain or requiring spine surgery
- Active medical conditions limiting naloxone safety (e.g., severe kidney/liver failure, unstable heart disease, infection, severe coagulopathy)
- Psychiatric, medical, neurologic, or pain disorders affecting accurate pain reporting
- Need for sedation to tolerate lumbar medial branch block
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
VA Tennessee Valley Healthcare System
Nashville, Tennessee, United States, 37212
Actively Recruiting
Research Team
W
William E Rivers, DO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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