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

NCT04522674 | Completed Early Phase 1

• 1 other identifier: 19-3066
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Length of enrollment of 10 patients and attrition rate

  3 months

• Safety as measured by number of subjects with at least one adverse event

  3 months

• Degree of improvement in pain and function based on severity of lumbar facet OA.

  3 months

Study Arms (1)

Autologous platelet rich plasma

EXPERIMENTAL

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

Interventions

Autologous platelet rich plasma BIOLOGICAL

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

Autologous platelet rich plasma

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado School of Medicine Spine Center

Aurora, Colorado, 80045, United States

Location

Study Officials

• Venu R Akuthota, MD

  University of Colorado School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 21, 2020
• Study Start: February 19, 2021
• Primary Completion: April 28, 2022
• Study Completion: April 28, 2022
• Last Updated: May 4, 2022

Record last verified: 2022-05

Locations

US (1)