Chronic Degenerated Facet Low Back Pain Clinical Trial
Official title:
A Prospective Pilot Study to Evaluate the Safety and Efficacy of a Single Facet Injection of an Extracellular Vesicle Isolate Product in Treating Chronic Degenerated Facet Low Back Pain
The study format is a prospective non-randomized study to be conducted at a single site. Up to twenty consecutive DFLBP patients meeting the inclusion and exclusion criteria and who provide informed consent will be enrolled in the study. The patients will receive treatment compliant with national guidelines. Appropriate patients will be injected with 0.5cc of ExoFlo into each of their affected facet joint(s). The facets to be treated will be determined by imaging and Dr. Wilson. Up to three vertebral levels can be treated. Patients will be assessed with pre and post-treatment physical examination. At baseline, Brief Pain Inventory (BPI) and Visual Analogue Scale (VAS) will be documented. BPI and VAS scoring will be collected at 24 hours, 3 days, 7 days, 1 month, 2 months and 3 months after each treatment. Adverse events will be monitored by follow-up phone calls at 24, 48 hours, 1 week after the procedure and at all follow-up visits. Patients drug usage will be monitored. Patient will be instructed to call the office any time after treatment if they are experiencing any adverse events. A patient can leave the study at any time.
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