Bone marrow concentrate intradiscal injection for chronic discogenic low back pain: A double-blind randomized sham-controlled trial

Abstract

Summary of background

The field of orthobiologics has attempted to address the challenge of discogenic low back pain (LBP). Research in areas such as stem cells, platelet-rich plasma, and specific growth factor injections has seen limited success.

Objective

The purpose of this trial was to determine the efficacy of a single intradiscal bone marrow concentrate (BMC) injection on pain and function for chronic discogenic LBP.

Methods

Patients with presumed discogenic LBP participated in a prospective, double-blind, randomized, sham controlled trial of a single intradiscal BMC injection compared to a sham procedure. Pain and function were assessed at baseline, 3, 6, and 12 months by Clinical Outcome Measurement Brief Instrument (COMBI) which includes the Numeric Rating Scale (NRS). Function was also assessed by the Oswestry Disability Index (ODI). The primary outcome was based upon clinical success, defined by at least 50 % pain relief from baseline to 3, 6, and 12 months.

Results

Sixty-three patients were included in the trial (45 BMC, 18 sham). There were no significant differences in the primary outcome (>50 % relief in NRS) at 3 months (40 % BMC group [95 %CI: 27–50 %] vs 33 % sham group [95 %CI: 15–56 %]), 6 months (40 % BMC [95 %CI: 27–50 %] vs 39 % sham [95 %CI: 20–61 %]), or 12 months (44 % BMC [95 %CI: 31–59 %] vs 56 % sham [95 %CI: 34–75 %]). There were no significant differences in the proportion of patients achieving at least a 30 % improvement on the ODI at 3 months (51 % BMC group [95 %CI: 37–65 %] vs 33 % sham group [95 %CI: 16–56 %]), 6 months (53 % BMC [95 %CI: 39–67 %] vs 44 % sham [95 %CI: 25–65 %]), or 12 months (56 % BMC [95 %CI: 41–69 %] vs 61 % sham [95 %CI: 39–80 %]).

Conclusions

Intradiscal BMC was equivalent to a sham procedure for chronic discogenic LBP. Both groups had a high, but statistically equivalent success rate. Unfortunately, the significant limitations of this trial, including lack of quality cell analysis, limit the ability to draw conclusions on the effectiveness of intradiscal BMC.