Platelet-Rich Plasma (PRP) for Treatment of Symptomatic Lumbar Facet Syndrome of the Spine

University of Colorado Denver (CU Denver)

Status and phase: Completed; Early Phase 1

Conditions: Platelet-Rich Plasma

Treatments: Biological: Autologous platelet rich plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT04522674

19-3066

Details and patient eligibility

About

The purpose of this study is to investigate the feasibility of standardized autologous platelet rich plasma injections into osteoarthritic lumbar facet joints to treat back pain and improve patient function.

Enrollment: 5 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Suspicion of z-joint mediated low back pain
• Pain rating of ≥4/10 on a VAS scale
• Symptom duration of 3 or more months
• Failed conservative therapy (minimum of PT and pain medications)
• Have diagnosis of lumbar facet syndrome after MRI, X-ray, or CT imaging of any severity and a medial branch block with local anesthetic that confirms lumbar facet pathology.

Exclusion criteria

• Inability to undergo fluoroscopically guided procedures
• Current pregnancy
• Prior spinal surgery with hardware
• Intolerance to local anesthesia, contrast medium, or blood derivatives
• Local or systemic infection or spinal infection
• Irreversible coagulopathy
• Patients that require strict anticoagulation and cannot be off antiplatelet medication for at least a week
• Less than 18 years of age
• Corticosteroid shot within last 3 months into affected lumbar facet joint because of concern of damage to cartilage in the joint in that time period.
• Patients with workman compensation related back pain
• Patients with rheumatic cause of lumbar facet arthritis.
• Patients who have had a radiofrequency neurotomy of the nerves innervating their affected facet joints within the last year

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Autologous platelet rich plasma

Experimental group

Description:

0.5 mL of activated autologous PRP will be injected by fluoroscopic guidance into the affected lumbar facet joint (s) depending on the number of affected levels. A max of 4 joints will be injected per patient.

Treatment:

Biological: Autologous platelet rich plasma