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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
0.5 mL autologous platelet rich plasma into a symptomatic osteoarthritic lumbar facet to treat back pain caused by lumbar facet syndrome
University of Colorado School of Medicine Spine Center
Aurora, Colorado, United States
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
Time frame: 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.
Time frame: Baseline, immediately after intervention, 1 week, 1 month, and 3 months post intervention
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
Time frame: 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.
Time frame: 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
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Time frame: 3 months