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

TL;DR

A study found that injecting bone marrow concentrate into the spine for chronic back pain was no better than a fake treatment, with both groups showing similar results.

Contribution

This is the first double-blind randomized sham-controlled trial to evaluate bone marrow concentrate for chronic discogenic low back pain.

Findings

Bone marrow concentrate injections showed no significant improvement in pain relief compared to a sham procedure.

Both groups had similar success rates in pain and function outcomes at 3, 6, and 12 months.

The trial's limitations, such as lack of cell quality analysis, hinder conclusions about BMC's effectiveness.

Abstract

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.

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.

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.

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 %]).

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.

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