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

Recruitment & Eligibility

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 & Design

Arm && Interventions

Group	Intervention	Description
Autologous platelet rich plasma	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.

Primary Outcome Measures

Name	Time	Method
Change in pain Visual Analog Score with back flexion and at rest from baseline after intervention over time.	Baseline, immediately after intervention, 1 week, 1 month, and 3 months post intervention	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
PROMIS Survey for Low Back Pain Function (PROMIS-29)	Baseline, immediately after intervention, 1 week, 1 month, and 3 months post intervention	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.

Secondary Outcome Measures

Name	Time	Method
Length of enrollment of 10 patients and attrition rate	3 months	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
Degree of improvement in pain and function based on severity of lumbar facet OA.	3 months	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
Safety as measured by number of subjects with at least one adverse event	3 months	Monitoring of adverse events such as bleeding, infection, allergy, neurologic deficits, and injection-related complications.

Recruitment & Eligibility