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

Overview

About this study

The purpose of this study is to assess the safety of the Angel® Concentrated Platelet Rich Plasma System and Angel® CPRP Processing Set to process Platelet Rich Plasma for intra-articular injection into four lumbar facet joints (2 levels) causing chronic low back pain.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.
  • Age 22-70 years.
  • 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.
  • Use of illicit drugs within 30 days prior to study entry.
  • NSAID use during the pre-procedural period (one week before Treatment Day 0).
  • Preoperative hematocrit less than 36%.
  • History of hemodynamic instability or inability to maintain stable oncotic pressure.
  • History of prolonged clotting times.
  • Prior history of lumbar procedure.
  • Redness, swelling, rash or other concerning lesions at the injection site just prior to the procedure.
  • Prior history of allergy to lidocaine or other local anesthetic agent.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Matthew Pingree, M.D.

Open for enrollment

Contact information:

Matthew Pingree M.D.

(507) 266-9240

Pingree.Matthew@mayo.edu

More information

Publications

Publications are currently not available