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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Platelet-Rich Plasma

Intervention / Treatment
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* Biological: Autologous platelet rich plasma


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous platelet rich plasma<br>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<br>* 0.5 mL autologous platelet rich plasma into a symptomatic osteoarthritic lumbar facet to treat back pain caused by lumbar facet syndrome<br>|

What is the study measuring?
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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 |