Riassunto dello studio

Sixty-three patients with chronic discogenic low back pain were randomized to receive a single intradiscal bone marrow concentrate (BMC) injection (n=45) or a sham spinal injection without disc puncture (n=18). The primary outcome of interest was clinical success, defined as at least 50% reduction in Numeric Rating Scale (NRS) pain from baseline at 3, 6, and 12 months. Secondary outcomes of interest included ≥30% improvement in NRS, ≥30% improvement in Oswestry Disability Index (ODI), patient global impression of change, and other components of the COMBI instrument (including pain interference, activity restoration, medication use, and work status). Outcomes were assessed at baseline and at 3, 6, and 12 months. Overall, the results of the study revealed that intradiscal BMC did not provide statistically superior pain or functional outcomes compared with the sham procedure, although both groups showed substantial improvement over baseline. These findings suggest that, in this trial, the observed benefits of intradiscal BMC may largely reflect non-specific or placebo-related effects rather than a specific biologic treatment effect.