Endogenous Opioid Response to Injections

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Middle Tennessee Research Institute
Study ID
NCT06666621
Phase
PHASE4
Status
Recruiting
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Conditions

  • Low Back Pain
  • Zygapophyseal Joint Arthritis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Normal saline infusion — 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 — 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

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.

Key Dates

Start date
Aug 22, 2024
Status verified
May 2025
Primary completion
Oct 31, 2025
Completion
Feb 28, 2026

Study Design

Enrollment
33 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Other: Single arm study: endogenous opioid blockade
    This is a single group study. The participants will undergo two sequential experimental conditions: saline infusion and naloxone infusion. Participants will be identified as candidates for standard of care lumbar medial branch block, consented, and enrolled. Baseline demographics and patient reported clinical measures will be collected. All participants will have IV placed, undergo standard of care lumbar medial branch block, wait 20 minutes, then have their response to procedure assessed. Then normal saline will be infused through the IV over several minutes, 10 minutes will pass, and response to procedure re-assessed. Then naloxone will be infused through the IV over several minutes, 10 minutes will pass, and response to procedure re-assessed for a final time. IV will then be removed. Participants will then follow standard of care clinical practice for second lumbar medial branch block and lumbar medial branch radiofrequency neurotomy treatment.

Primary Outcome Measure

Endogenous opioid-dependent placebo analgesia [ Time Frame: 10 minutes after naloxone infusion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Tennessee Valley Healthcare SystemNashvilleTennessee37212
William E Rivers, DO
[email protected]
615-225-6559

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By research site
VA Tennessee Valley Healthcare System· Nashville, TN

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