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Understanding Pain Relief from Spine Injections for Low Back Pain

This study is looking at how different types of pain relief work after spine injections for low back pain. It aims to understand if some pain relief comes from a 'placebo effect' (your body's natural pain relief system) rather than just the injection itself. You might be able to join if you are 18 or older, have had low back pain for at least three months that hasn't improved with usual treatments, and your pain is rated 4 out of 10 or higher. Participants will receive an intravenous (IV) infusion of normal saline, followed by an IV infusion of naloxone. Naloxone is a medication that can block your body's natural pain relief system. The main goal is to measure how much pain relief is due to your body's natural system after the naloxone infusion. The study status is currently unclear.

Study design
This interventional study plans to enroll 33 participants. It will involve giving participants specific treatments (normal saline and naloxone infusions) and then observing their response.
What's involved
You will receive an infusion of normal saline, followed by a re-assessment of your pain. Then, you will receive an infusion of naloxone, followed by a final pain re-assessment.
Compensation
Not stated in the trial record.
Follow-up
Your pain response will be measured at 10 minutes after the naloxone infusion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06666621

Endogenous Opioid Response to Injections

Recruiting
PHASE4Ages 18+InterventionalDiagnostic
Middle Tennessee Research Institute
~33 participants
Updated 2025-05-18 on ClinicalTrials.gov
What's tested:Normal saline infusionNaloxone infusion

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Endogenous opioid-dependent placebo analgesia
Measured over 10 minutes after naloxone infusion

Conditions

Low Back Pain
Zygapophyseal Joint Arthritis

Explore related trials

Lower Back PainZygapophyseal Joint Arthritis

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

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

Who to contact

William E Rivers, DO
[email protected]
859-513-9793
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Endogenous opioid-dependent placebo analgesia10 minutes after naloxone infusion

    Endogenous opioid-dependent placebo analgesia is defined as change in analgesia after lumbar medial branch block #1 (measured by numeric pain rating scale) after infusing naloxone