Procedure with unproven benefit, not covered by insurance, not FDA approved, with significant risk. There are a few human studies with low "n" subject numbers. (none of the spine PRP studies have been placebo controlled or blinded)
Intradiscal Injection of Autologous Serum Isolated From Platelet‐Rich‐Plasma for the Treatment of Discogenic Low Back Pain: Preliminary Prospective Clinical Trial: Gp141
Akeda, Koji1; Imanishi, Takao1; Ohishi, Kohshi2; Masuda, Koichi3; Uchida, Atsumasa4; Sakakibara, Toshihiko5; Kasai, Yuichi5; Sudo, Akihiro1
1Mie University Graduate School of Medicine, Orthopaedic Surgery, Tsu, Japan; 2Mie University Hospital, Transfusion Service, Tsu, Japan; 3University of California, San Diego, Orthopaedic Surgery, La Jolla, US; 4Mie University, Tsu, Japan; 5Mie University Graduate School of Medicine, Spinal Surgery and Medical Engineering, Tsu, Japan
INTRODUCTION: The treatment of degenerative disc disease is one of the most challenging clinical problems facing the spine surgeon. Activated platelets are known to release several kinds of growth factors that contribute to tissue repair. Serum isolated from platelet‐rich‐plasma (PRP‐serum) has recently been demonstrated to influence the metabolism of intervertebral discs in vitro and in vivo. Based on a preclinical study, we performed a preliminary clinical trial to determine the safety and efficacy of an intradiscal injection of autologous PRP‐serum in patients with discogenic low back pain.METHODS: Inclusion criteria for this study included chronic low back pain without leg pain for more than 3 months; one or more lumbar discs (L3/L4 to L5/S1) with evidence of degenerative changes on magnetic resonance imaging (MRI); and at least one symptomatic disc confirmed using standardized provocative discography. PRPserum, isolated from clotted PRP, was injected (2.0 ml) into the center of the nucleus pulposus. Outcome measures included the visual analog scale (VAS), Roland‐Morris Disability Questionnaire (RDQ), X‐ray and MRI (T2‐quantification).RESULTS: Data were analyzed from 6 patients (3 men, 3 women; mean age 34.4 years‐old) who had completed 6 months follow‐up. After treatment, no patient showed adverse events or significant narrowing of disc height. The mean pain score before treatment was significantly decreased at one month (VAS score: 7.1±1.2 to 1.8±2.0, p<0.01; RDQ score: 11±1.8 to 3.2±2.4, p<0.01); this was sustained for six months after treatment. The mean T2 values did not change significantly after treatment (p=0.18).DISCUSSION: The intradiscal injection of autologous PRP‐serum in patients with low back pain has been shown to be safe and effective for six months after treatment. Future long‐term follow‐up and/or randomized control studies should be performed to evaluate the effects of this therapy.
© 2011 Lippincott Williams & Wilkins, Inc.