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 range22 Years – 70 Years
SexALL
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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…
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