RECRUITING

Endogenous Opioid Response to Injections

Conditions

Low Back Pain Zygapophyseal Joint Arthritis zygapophysial joint arthritis endogenous opioids lumbar medial branch block

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Antagonism of Endogenous Opioids: Use in Interpretation of Injections

Quick Facts

Study Start:2024-08-22

Study Completion:2026-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06666621

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

William E Rivers, DO

CONTACT

859-513-9793

william.rivers@va.gov

Principal Investigator

William E Rivers, DO

PRINCIPAL_INVESTIGATOR

Tennessee Valley Healthcare System VA

Study Locations (Sites)

VA Tennessee Valley Healthcare System

Nashville, Tennessee, 37212

United States

Collaborators and Investigators

Sponsor: Middle Tennessee Research Institute

William E Rivers, DO, PRINCIPAL_INVESTIGATOR, Tennessee Valley Healthcare System VA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-22

Study Completion Date2026-02

Study Record Updates

Study Start Date2024-08-22

Study Completion Date2026-02

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Low Back Pain
Zygapophyseal Joint Arthritis