NCT06666621 Endogenous Opioid Response to Injections
| NCT ID | NCT06666621 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Middle Tennessee Research Institute |
| Condition | Low Back Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 33 participants |
| Start Date | 2024-08-22 |
| Primary Completion | 2025-10 |
Trial Parameters
Eligibility Fast-Check
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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.
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 conditi