Status:
COMPLETED
Platelet-Rich Plasma (PRP) for Treatment of Symptomatic Lumbar Facet Syndrome of the Spine
Lead Sponsor:
University of Colorado, Denver
Conditions:
Platelet-Rich Plasma
Eligibility:
All Genders
18-95 years
Phase:
EARLY_PHASE1
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 fu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2022
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04522674
Start Date
February 19 2021
End Date
April 28 2022
Last Update
May 4 2022
Active Locations (1)
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1
University of Colorado School of Medicine Spine Center
Aurora, Colorado, United States, 80045