Study Evaluating the Safety and Feasibility of Platelet-rich Plasma to Treat Facetogenic Low Back… (NCT05250947) | Clinical Trial Compass
TerminatedPhase 1
Study Evaluating the Safety and Feasibility of Platelet-rich Plasma to Treat Facetogenic Low Back Pain
Stopped: Projected cost to continue was not supported by the study budget and additional funds could not be obtained so the decision to close the study was made.
United States4 participantsStarted 2023-01-05
Plain-language summary
This study is being done to assess the safety of using the Angel Concentrated Platelet Rich Plasma System to process Platelet Rich Plasma (PRP) to treat arthritis of the low back (lumbar spondylosis).
Who can participate
Age range
22 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Clinical and radiographic (MRI, CT or lumbar x-ray) evidence of symptomatic facet arthropathy involving the bilateral bottom two facets (e.g., L4-5 or L5-6 and L5-S1 or L6-S1).
* Positive response, defined according to current clinical standards for the diagnosis of facet-mediated low back pain as greater than or equal to 75% pain improvement (as reported by patient) to diagnostic medial branch nerve blocks, one block with lidocaine and the other with bupivacaine.
* Low back pain VAS score of greater than or equal to 5 at the clinical visit just prior to the first medial branch nerve block.
Exclusion Criteria:
* Prior facet related procedure (intraarticular corticosteroid injection, radiofrequency ablation (RFA)) in last 6 months or prior fusion in the bottom two facets.
* Current opioid use of greater than 50mg oral morphine milligram equivalents per day.
* No advanced imaging (MRI, CT or lumbar x-ray) of the lumbar spine within the last 6 months.
* BMI \> 34.99 (WHO class I obesity).
* Active systemic or local infection as evidenced by fever \>100.4 degrees Fahrenheit, or any other clinical signs or symptoms of infection within 24 hours of the procedure.
* On anticoagulation drug and has been on hold for less than 7 days prior to the investigational procedure.
* Imaging evidence of high likelihood of failure for intra-articular injection in the opinion of the PI or delegate review of MRI, CT or lumbar x-ray imaging.
* History of chronic thrombocytop…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of adverse device effects
Timeframe: Day 0 (Day of procedure)
2
Number of suspected acute adverse reactions to the treatment