What this study is
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.
What's being tested
- Normal saline infusion
Intervention · DRUG
After assessment of response to lumbar medial branch block, 8 ml normal saline will be infused through IV over several minutes. 10 minutes will pass, and response to lumbar medial branch block procedure will be re-assessed. After this step, naloxone infusion will occur (see next intervention)
- Naloxone infusion
Intervention · DRUG
After infusion of normal saline and re-assessment of response to lumbar medial branch block procedure, 8 milligrams of naloxone will be infused over several minutes. Then after 10 minutes, response to lumbar medial branch block procedure will be re-reassessed for the final time.
Study details
- Official title
- Antagonism of Endogenous Opioids: Use in Interpretation of Injections
- Sponsor
- Middle Tennessee Research Institute
- Conditions
- Low Back Pain · Zygapophyseal Joint Arthritis
- Enrolling
- 33 people
- Starts
- 2024-08-22
- Est. completion
- 2026-02
- Design
- Open-label, single group, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Capable of understanding and providing consent in English and capable of complying with the outcome instruments used
- ≥3 months low back pain with persistent limiting symptoms despite conventional treatment (physical therapy and oral medications)
- Low back pain NRS ≥ 4/10 in intensity on 7-day average and at time of lumbar medial branch block
You can't join if
- Daily use of opioid medications or recreational drugs, or if using opioids PRN, report of opioid use within the 3 days prior to participating in the protocol
- Positive urine drug screen for opioid medication on the day of naloxone administration
- Allergy to naloxone
- Refusal of or failure to place IV
- Previous LMBB or LMBRN
- Known spine condition that may affect the ability to diagnose or treat facet pain or lead to spine surgery (e.g. instability, severe spinal stenosis, radiculopathy, previous spine operation resulting in alteration of anatomy targeted by LMBB or LMBRFN)
- Active medical condition that would limit the safety of naloxone administration (e.g. severe kidney or liver failure, unstable cardiac disease, infection, severe coagulopathy)
- Psychiatric, medical, neurologic, or pain-related disorder that may compromise the ability of the patient to accurately report changes in low back pain
- Requirement for procedural sedation to tolerate LMBB
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openVA Tennessee Valley Healthcare System
Nashville, Tennessee, United States
- William E Rivers, DO · Contact615-225-6559william.rivers@va.gov
Recruiting
Study team
Sponsor
Middle Tennessee Research Institute
Study ID 1792559
Principal investigator
William E Rivers, DO
Tennessee Valley Healthcare System VA
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.