Ensayos clínicos

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 ?l).

- 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 2/21/23. Questions regarding updates should be directed to the study team contact.