Evaluating the Role of Endogenous Opioids in Pain Relief from Spine Injections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the pain relief effects of lumbar medial branch blocks (LMBB) in patients with low back pain and zygapophyseal joint arthritis. It aims to differentiate between the physiological effects of the nerve block and the placebo response by using naloxone, an opioid receptor antagonist, to block the body's endogenous opioids. By measuring pain relief before and after the administration of naloxone, the study seeks to enhance understanding of how these injections guide pain management. The findings could lead to improved treatment protocols for patients suffering from chronic low back pain.

Why it matters

Who can join: the full rules

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

Where it's running

• VA Tennessee Valley Healthcare System
  Nashville, Tennessee, United States Recruiting

Study contacts

• Principal investigator: William E Rivers, DO — Tennessee Valley Healthcare System VA
• Study coordinator: William E Rivers, DO
• Email: william.rivers@va.gov
• Phone: 859-513-9793

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• A novel multi angular isometric lumbar exercise for chronic low back pain

  This trial tests MAILE, a new lumbar exercise method, to see if it helps adults with nonspecific chronic low back pain more than standard lumbar stabilization and core exercises.

  Recruiting Hamad Medical Corporation · Doha · NCT07908693

• Pain catastrophizing, fear of movement, and activity in postmenopausal women with chronic low back pain

  This observational study looks at how negative pain thoughts and fear of moving relate to how active postmenopausal women with long‑standing low back pain are.

  Recruiting Istanbul Medipol University Hospital · Istanbul, Istanbul · NCT07856498

• Analgesia boost from adding a sacral submultifidus block to SIJ injection

  This study tests whether adding a sacral submultifidus block to a standard image-guided sacroiliac joint injection provides better pain relief and function for adults with chronic SIJ‑related pain.

  Recruiting Fayoum University Hospital · Al Fayyum · NCT07814729

• Telerehabilitation after spine surgery

  This trial tests different ways of delivering post-operative instructions to people who had spinal decompression surgery to see how it affects recovery and healthcare use.

  Recruiting Kuopio University Hospital · Kuopio · NCT07795697

• How patient education helps people with chronic musculoskeletal pain stick to home exercise for pain relief

  A structured patient education program is tested to see if it helps people with chronic low back pain, knee osteoarthritis, and shoulder problems stick with their home exercise plan to relieve pain.

  Recruiting Imam Abdulrahman Bin Faisal University · Dammam, Eastern Province · NCT07764354

• Core endurance vs segmental stabilization for low back pain in recreational athletes

  This trial tests whether core endurance exercises or segmental stabilization exercises better help recreational athletes with non-specific low back pain.

  Recruiting Uskudar University · Istanbul · NCT07760103

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.