Endogenous Opioid Response to Injections

Launched by MIDDLE TENNESSEE RESEARCH INSTITUTE · Oct 29, 2024

Keywords

ClinConnect Summary

This clinical trial, called "Endogenous Opioid Response to Injections," is looking at how effective spine injections are for relieving low back pain, particularly pain related to a specific type of joint arthritis in the back. Researchers want to understand if some of the pain relief people feel after these injections comes from a natural response in the body, known as the placebo effect, rather than just the injection itself. To do this, they will use a medication called naloxone, which can block the body's natural pain-relieving system, allowing them to see how much of the relief is due to the injection versus the placebo effect.

To participate in this study, individuals need to be between 65 and 74 years old, have experienced low back pain for at least three months, and still feel significant pain despite trying other treatments like physical therapy and medications. Participants will need to be able to understand and follow study instructions. They will be closely monitored during the trial, and the researchers will provide detailed information about what to expect throughout the process. It's important to note that certain medical conditions or recent use of specific medications may prevent someone from being eligible for this study.

Gender

ALL

Eligibility criteria

• 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