A Prospective Pilot Study in Treating Chronic Degenerated Facet Low Back Pain
Status:
Completed
Trial end date:
2021-09-01
Target enrollment:
Participant gender:
Summary
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.