Study Finds Bone Marrow-Derived Stem Cells No Better Than Placebo for Chronic Low Back Pain
The trial found no significant difference in pain or function outcomes between bone marrow injections and sham procedures over 12 months, but also had important limitations.
Key findings
- A randomized, double-blind, sham-controlled trial found intradiscal bone marrow concentrate (BMC) injections performed similarly to a sham procedure for chronic discogenic low back pain.
- Across 3, 6, and 12 months, there were no significant differences between groups in rates of at least 50% pain relief or meaningful improvement in disability.
- The authors highlight key limitations, including a lack of cell quality analysis, which limits conclusions about intradiscal BMC effectiveness.
Results from a prospective, double-blind, randomized, sham-controlled trial evaluated whether a single intradiscal injection of bone marrow concentrate (BMC) improves pain and function in patients with chronic discogenic low back pain (low back pain presumed to originate from an intervertebral disc).
The trial can be found here (NCT03340818) and the paper was published in Interventional Pain Medicine.
Study Design
Patients with presumed discogenic low back pain were randomized to receive either a single intradiscal BMC injection or a sham saline injection. Pain and function were assessed at baseline and again at 3, 6, and 12 months.
Outcome measures included:
- Clinical Outcome Measurement Brief Instrument (COMBI), including the Numeric Rating Scale (NRS) for pain
- Oswestry Disability Index (ODI) for function and disability
The primary outcome was “clinical success,” defined as at least 50% pain relief from baseline at 3, 6, and 12 months.
The Results
A total of 63 patients were included (45 BMC, 18 sham). The trial did not find significant differences between groups for the primary outcome at any time point:
- 3 months: 40% (BMC) vs 33% (sham) achieved >50% relief in NRS
- 6 months: 40% (BMC) vs 39% (sham) achieved >50% relief in NRS
- 12 months: 44% (BMC) vs 56% (sham) achieved >50% relief in NRS
- 3 months: 51% (BMC) vs 33% (sham)
- 6 months: 53% (BMC) vs 44% (sham)
- 12 months: 56% (BMC) vs 61% (sham)
What the Authors Concluded (and What They Couldn’t)
The authors concluded that intradiscal BMC was equivalent to a sham procedure for chronic discogenic low back pain, and that both groups had a high but statistically equivalent success rate.
However, candidly, they flagged “significant limitations,” including a lack of quality cell analysis. It appears they sent 5 non-randomized samples of bone marrow/BMC to a third-party lab, which found “no living cells” in the samples.
Additionally, they did not do an intradiscal puncture for the sham group for ethical/safety reasons, and the physician administering the injection was unblinded, so it appears it was not a “perfect” placebo.
These could limit the ability to draw conclusions, whether positive or negative, in this trial.
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