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

A Pilot Trial Evaluating the Feasibility of Using Platelet-Rich Plasma (PRP) for Treatment of Symptomatic Osteoarthritis of the Lumbar Facet Joint(s) of the Spine

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.

Study Overview

• Status: Completed
• Conditions: Platelet-Rich Plasma
• Intervention / Treatment: Biological: Autologous platelet rich plasma

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado School of Medicine Spine Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Biological: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain Visual Analog Score with back flexion and at rest from baseline after intervention over time.	Pain as assessed from 0-10. Where 10 is severe pain and 0 is no pain. Improvement of pain by 50% after intervention is defined as treatment success	Baseline, immediately after intervention, 1 week, 1 month, and 3 months post intervention
PROMIS Survey for Low Back Pain Function (PROMIS-29)	NIH validated PROMIS score for physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, pain interference, and pain intensity (PROMIS- 29 Profile v2.0). A higher PROMIS T-score represents more of the concept being measured.For negatively-worded concepts like Anxiety,a T-score of 60 is one SD worse than average.By comparison,an Anxiety T-score of 40 is one SD better than average.However,for positively-worded concepts like Physical Function-Mobility,a T-score of 60 is one SD better than average while a T-score of 40 is one SD worse than average.	Baseline, immediately after intervention, 1 week, 1 month, and 3 months post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of enrollment of 10 patients and attrition rate	Determine percentage of patients who enroll in the study, how long it takes to enroll 10 patients, and attrition rate of patients in a 3 month time period	3 months
Safety as measured by number of subjects with at least one adverse event	Monitoring of adverse events such as bleeding, infection, allergy, neurologic deficits, and injection-related complications.	3 months
Degree of improvement in pain and function based on severity of lumbar facet OA.	Using the surveys from the primary outcome, the investigators plan to perform a subgroup analysis depending on the severity of lumbar facet OA as seen by imaging	3 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Venu R Akuthota, MD, University of Colorado School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 19, 2021
• Primary Completion (ACTUAL): April 28, 2022
• Study Completion (ACTUAL): April 28, 2022

Study Registration Dates

• First Submitted: August 17, 2020
• First Submitted That Met QC Criteria: August 20, 2020
• First Posted (ACTUAL): August 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 4, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 19-3066

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No