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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous platelet rich plasma | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous platelet rich plasma | Biological | 0.5 mL autologous platelet rich plasma into a symptomatic osteoarthritic lumbar facet to treat back pain caused by lumbar facet syndrome |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Venu R Akuthota, MD | University of Colorado School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado School of Medicine Spine Center | Aurora | Colorado | 80045 | United States |
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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 |