A Prospective Pilot Study in Treating Chronic Degenerated Facet Low Back Pain

• Status: Completed
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Direct Biologics, LLC

Criteria

Inclusion Criteria: All candidates for this study must meet ALL of the following Inclusion Criteria to be eligible for enrollment:

• Voluntary signature of the approved Informed Consent

• Subject must be over 18 years old.

• A minimum 6-month diagnosis of DFLBP defined based on INCLUSION criteria.

• The DFLBP can be from any etiology.

• The patient must be currently on regular treatments and/or medications for their DFLBP diagnosis.

• MRI evidence of one or up to three levels of facet degeneration.

• Primary symptom complaint of degenerated facet caused low back pain. This will be established by MRI imaging documenting facet degeneration and a diagnostic image guided facet injection of an anesthetic that provides the patient at least a 70% reduction of their LBP for a period of time appropriate for the anesthetic used.

Exclusion Criteria: Candidates who meet ANY of the following Exclusion Criteria at the time of the study procedure are NOT eligible for enrollment in the study:

• The subject is unable to conform to the study protocol follow-up procedures and visits.

• The subject has major risk factors such as a history of narcotic abuse, paucity of family support, unemployed, history of previous physical or mental abuse or severe medical comorbidities.

• Patients with any auto-immune disorder.

• Any patient felt not to be a suitable study patient by the principal Investigator.

• Radiographic evidence of spondylolysis or spondylolisthesis.

• Symptomatic stenosis or disc herniation resulting in leg greater than back pain.

• Symptomatic discogenic pain.

• Patients with hematologic blood dyscrasias, platelet dysfunction, septicemia/fever, malignancy, cutaneous infections in area to be treated or severe psychiatric impairment or unrealistic expectations.