Recruiting

Endogenous Opioid

Sponsor:

Middle Tennessee Research Institute

Code:

NCT06666621

Conditions

Low Back Pain

Zygapophyseal Joint Arthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Normal saline infusion

Naloxone infusion

Study Details

Brief 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

Study ID

NCT06666621

Start date

Aug 22, 2024

Status verified date

May, 2025

Completion date

Feb, 2026

Anticipated

Primary completion date

Oct, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

33 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

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)

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

William E Rivers, DO

859-513-9793william.rivers@va.gov

Locations

VA Tennessee Valley Healthcare System

Recruiting

Nashville, Tennessee, United States, 37212

Contacts

William E Rivers, DO

615-225-6559william.rivers@va.gov

More Information

Sponsor

Middle Tennessee Research Institute

Last update posted

May 18, 2025

Last verified

May, 2025

Keywords

  • low back pain
  • zygapophysial joint arthritis
  • endogenous opioids
  • lumbar medial branch block

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Middle Tennessee Research Institute on 2025-05-18.