Platelet-Rich Plasma
Conditions
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.
Interventions
BIOLOGICALAutologous platelet rich plasma
0.5 mL autologous platelet rich plasma into a symptomatic osteoarthritic lumbar facet to treat back pain caused by lumbar facet syndrome
Sponsors
University of Colorado, Denver
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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 |
Countries
United States
Outcome results
None listed