BridgeMD
New treatment option for Low Back Pain
Official title Endogenous Opioid Response to Injections
ClinicalTrials.gov ID: NCT06666621
What this study is testing
What is Normal saline infusion?
Normal saline infusion is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for low back pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- 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...
See the full eligibility 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.