Affiliations: USA StemCell, 7000 SW 62nd Ave, Suite PH-S, Miami, FL 33143, USA | Tel.: +1 305 250 2355; E-mail: [email protected]
Correspondence:
[*]
Corresponding author: USA StemCell, 7000 SW 62nd Ave, Suite PH-S, Miami, FL 33143, USA. Tel.: +1 305 250 2355; E-mail: [email protected].
Abstract: BACKGROUND: Facet joint syndrome (FJS) pain is a significant contributor to back pain and has a high rate of opioid prescription. Unfortunately, there are a limited number of therapeutic options for these patients. OBJECTIVE: To evaluate the safety and effectiveness of amniotic membrane/umbilical cord particulate (AM/UC) in managing FJS pain. METHODS: A single-center, investigator-initiated, retrospective study was performed on consecutive patients with FJS pain who received intra- or peri-articular injection of AM/UC between July 1, 2018 and July 26, 2019. Primary outcome was change in Patient Global Impression of Change (PGIC) at 6 weeks, 3 months, 6 months, and 12 months to assess the self-reported percent improvement relative to baseline. Safety was assessed by AM/UC- and procedure-related complications. Paired t-tests were used to determine whether there is a statistically significant improvement of pain post-injection compared to baseline. RESULTS: There were a total of 54 patients (69.7 ± 13.4 years; 31 female) presenting baseline pain score of 9.2 ± 1.0 despite prior treatments of activity modification (66.7%), NSAIDs (61.1%), opioids (37.0%), and physical therapy (35.2%). Mean GPIC improvement was 65.3%, 67.5%, 56.9%, and 56.7% among responders30, respectively. There were no complications. CONCLUSION: This study supports the safety and effectiveness of AM/UC particulate injection in managing FJS pain.
