1. 2022;25;29-34Safety and Efficacy of Platelet Rich Plasma for Treatment of Lumbar Discogenic Pain: A Prospective, Multicenter, Randomized, Double-blind Study
   Randomized Controlled Study
   Kennedy Mahdavi, BA, Hannah R. Barrows, BA, Jessica Lovine, BA, Matthew R. Peterson, MD, Daniel Franc, MD, PhD, Ramsin Benyamin, MD, Kent Remley, MD, Aaron Calodney, MD, Evish Kamrava, MD, Hyun Bae, MD, Margaret Anne Zielinski, BA, Natalie Eleanor Evans, BA, Taylor P. Kuhn, PhD, and Sheldon Jordan, MD.

BACKGROUND: Interventions for chronic discogenic spine pain are currently insufficient in lowering individual patient suffering and global disease burden. A 2016 study of platelet rich plasma (PRP) for chronic discogenic pain previously demonstrated clinically significant response among active group patients compared with controls.

OBJECTIVES: To replicate the previous research to move this intervention forward as a viable option for patient care.

STUDY DESIGN: A double-blind, randomized, placebo-controlled study.

SETTING: Multicenter private practices.

METHODS: Twenty-six (12 men, 14 women) human patients, ages 25 to 71 with a diagnosis of chronic lumbar discogenic pain, were randomly assigned to active (PRP) or control (saline) groups in a ratio of 2 active to 1 control. Baseline and follow-up Oswestry Disability Index and Numeric Pain Rating Scale questionnaires were obtained to track patient outcomes at 8 weeks postoperatively.

RESULTS: Within group assessment showed clinically significant improvement in 17% of PRP patients and clinically significant decline in 5% (1 patient) of the active group. Clinically significant improvement was seen in 13% of placebo group patients and no placebo patients had clinically significant decline secondary to the procedure.

LIMITATIONS: Possible explanations may include a range of factors including differences in patient demographics, outcome-measure sensitivity, or misalignment of statistical analyses.

CONCLUSIONS: These findings are markedly different than the highly promising results of the 2016 PRP study. This study posits necessary caution for researchers who wish to administer PRP for therapeutic benefit and may ultimately point to necessary redirection of interventional research for discogenic pain populations.

KEY WORDS: Degenerative, disc, growth factors, lumbar, pain, platelet, plasma, PRP, regenerative, spine