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Study Evaluating the Safety and Feasibility of Platelet-rich Plasma to Treat Facetogenic Low Back Pain | Clinical Trials | Clareo Health

TERMINATEDPHASE1

Study Evaluating the Safety and Feasibility of Platelet-rich Plasma to Treat Facetogenic Low Back Pain

A Phase I Study Evaluating the Safety and Feasibility of Platelet-rich Plasma for the Treatment of Facetogenic Low Back Pain

NCT05250947•Matthew Pingree

View on ClinicalTrials.gov

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).

Detailed Description

This study is a pilot of the safety of using the FDA cleared Angel® Concentrated Platelet Rich Plasma System and Angel® cPRP Processing Set to process PRP to treat arthritis of the low back (lumbar spondylosis). Subjects will be screened at outpatient clinic visit appointments and interested qualified subjects will be consented and offered participation in this trial. Once consent has been obtained baseline values will be established and subjects will begin treatment and follow-up for the next 12 months. A final visit for evaluation and collection of lab samples will be conducted at the end of the study.

Eligibility

Age

22 - 70 years

Sex

ALL

Healthy Volunteers

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 thrombocytopenia (or pre-operative platelet count less than 195,000 per μl).
•Undergoing chemotherapy at time of injection.
•Pregnant or breastfeeding.
+8 more criteria

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Key Dates

Start Date

January 5, 2023

Primary Completion Date

May 20, 2024

Completion Date

May 20, 2024

Last Updated

July 17, 2024

Enrollment

ACTUAL participants

Conditions

Lumbar Spondylosis

Interventions

Angel® Concentrated Platelet Rich Plasma System

DEVICE

Platelet Rich Plasma

DRUG

Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

NCT05029726

Lumbar Spinal StenosisLumbar Disc Herniation+8 more

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RECRUITINGNA

To Brace or Not to Brace for Single Level Lumbar Fusion Pilot

NCT03439228

Lumbar SpondylosisFusion of Spine

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 17, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study Evaluating the Safety and Feasibility of Platelet-rich Plasma to Treat Facetogenic Low Back Pain

Inclusion Criteria

Exclusion Criteria

Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

To Brace or Not to Brace for Single Level Lumbar Fusion Pilot

Safety and Efficacy of Pre-incisional Intravenous Ibuprofen to Reduce Postoperative Pain and Opioid Dependence After Posterior Cervical or Lumbar Instrumented Spine Surgery

EOTA With Or Without Mechanical Traction For Patients With Lumbar Spondylosis