Platelet-Rich Plasma Releasate versus Corticosteroid for the Treatment of Discogenic Low Back Pain: A Double-Blind Randomized Controlled Trial.

Koji Akeda,Rui Niimi,Kohshi Ohishi,Junichi Yamada,Norihiko Takegami,Akihiro Sudo,Yuki Nishimura,Tatsuhiko Fujiwara,Satoshi Tamaru,Toru Ogura,Takao Sudo,Takeshi Matsumoto

doi:10.3390/jcm11020304

Koji Akeda, Rui Niimi + Show 10 more

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https://doi.org/10.3390/jcm11020304

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Abstract

Clinical application of platelet-rich plasma is gaining popularity in treating low back pain (LBP). This study investigated the efficacy and safety of platelet-rich plasma releasate (PRPr) injection into degenerated discs of patients with discogenic LBP. A randomized, double-blind, active-controlled clinical trial was conducted. Sixteen patients with discogenic LBP received an intradiscal injection of either autologous PRPr or corticosteroid (CS). Patients in both groups who wished to have PRPr treatment received an optional injection of PRPr eight weeks later. The primary outcome was change in VAS from baseline at eight weeks. Secondary outcomes were pain, disability, quality of life (QOL), image analyses of disc degeneration, and safety for up to 60 weeks. The VAS change at eight weeks did not significantly differ between the two groups. Fifteen patients received the optional injection. Compared to the CS group, the PRPr group had a significantly improved disability score at 26 weeks and walking ability scores at four and eight weeks. Radiographic disc height and MRI grading score were unchanged from baseline. PRPr caused no clinically important adverse events. PRPr injection showed clinically significant improvements in LBP intensity equal to that of CS. PRPr treatment relieved pain, and improved disability and QOL during 60 weeks of observation.

Highlights

The Global Burden of Diseases, Injuries, and Risk Factors Study 2017 (GBD 2017) [1]conducted in 195 countries for 354 medical conditions reported that low back pain (LBP) was the leading cause of worldwide productivity loss and disability, with enormous socioeconomic and health impacts [2]
Patients were recruited via a rigorous selection process and received an intradiscal injection of either platelet-rich plasma releasate (PRPr) or the corticosteroid (CS)
Treatment success was defined as patients who met all of the following requirements: (1) Improvement of visual analogue scale (VAS) by more than 30% from baseline (% change: less than −30%); (2) more than 30% improvement in Oswestry Disability Index (ODI) from baseline (% change: less than −30%); (3) no additional treatment; and (4) no serious adverse events (AEs) following PRPr administration

Summary

Introduction

The Global Burden of Diseases, Injuries, and Risk Factors Study 2017 (GBD 2017) [1]conducted in 195 countries for 354 medical conditions reported that low back pain (LBP) was the leading cause of worldwide productivity loss and disability, with enormous socioeconomic and health impacts [2]. Among the anatomical elements comprising the lumbar spine, intervertebral disc (IVD) degeneration is one of the major causes of LBP [3]; this is termed ‘discogenic LBP’. IVD degeneration is accompanied by cellular and extracellular matrix changes in intradiscal microenvironments that eventually lead to structural breakdown and impaired IVD function [4]. Aberrant expression of proinflammatory cytokines found in degenerated human IVDs induces progressive degradation of major extracellular matrix components, including proteoglycan and type II collagen, by stimulating matrix-degrading enzymes [4]. Proinflammatory stimuli enhance the expression of nociceptive molecules within degenerated IVDs affecting sensory endings in the outer layer of the annulus fibrosus [3]. Matrix degradation with nociceptive stimuli in the inflammatory microenvironment is responsible for discogenic pain

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