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Low Back PainPainDiagnostics and screeningDrugPhase 4

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 ↗