MedTrace Logo

Endogenous Opioid Response to Injections

NCT06666621 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-05-18

No results posted yet for this study

Summary

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

  • Low Back Pain
  • Zygapophyseal Joint Arthritis

Interventions

DRUG

Normal saline infusion

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)

DRUG

Naloxone infusion

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.

Sponsors & Collaborators

  • International Pain and Spine Intervention Society

    collaborator UNKNOWN

  • Middle Tennessee Research Institute

    lead OTHER

Principal Investigators

  • William E Rivers, DO · Tennessee Valley Healthcare System VA

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-22
Primary Completion
2025-10-31
Completion
2026-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06666621 on ClinicalTrials.gov