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

NCT ID: NCT04522674

Last Updated: 2022-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-19
• Study Completion Date: 2022-04-28

Brief Summary

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.

Conditions

Platelet-Rich Plasma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Autologous platelet rich plasma

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.

Group Type: EXPERIMENTAL

Autologous platelet rich plasma

Intervention Type: BIOLOGICAL

0.5 mL autologous platelet rich plasma into a symptomatic osteoarthritic lumbar facet to treat back pain caused by lumbar facet syndrome

Interventions

Autologous platelet rich plasma

0.5 mL autologous platelet rich plasma into a symptomatic osteoarthritic lumbar facet to treat back pain caused by lumbar facet syndrome

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Venu R Akuthota, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado School of Medicine

Locations

University of Colorado School of Medicine Spine Center

Aurora, Colorado, United States

Countries

United States

Other Identifiers

19-3066

Identifier Type: -

Identifier Source: org_study_id