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Fischgrund et al. Intraosseous basivertebral nerve ablation for chronic low-back pain

One-paragraph summary

The SMART investigational-device trial randomized 225 selected adults with chronic axial low-back pain and Modic type 1 or 2 changes to radiofrequency basivertebral-nerve ablation (147) or sham (78). Mean baseline ODI was 42. At three months, ODI decreased 20.5 points with ablation and 15.2 with sham (between-group p=0.019 in the per-protocol population); ≥10-point ODI response occurred in 75.6% versus 55.3% (PMID 29423885). The trial established a sham-controlled efficacy signal while also showing a large sham response and narrow phenotype.

Key findings

  • 225 randomized participants; mean age 47 years.
  • All had Modic type 1 or 2 changes at treated vertebrae.
  • Three-month ODI change: −20.5 versus −15.2.
  • ≥10-point ODI responders: 75.6% versus 55.3%.
  • Prospective, multicenter, double-blind and sham controlled.

Limitations

  • Narrow inclusion/exclusion criteria.
  • Primary reported comparison used per-protocol analysis.
  • Large sham improvement reduces absolute specific effect.
  • Device/sponsor context and specialist centers.
  • Does not establish that every Modic lesion is painful.
  • Long-term reports no longer retain the randomized sham comparison.

Why it matters

This was the pivotal mechanistic clinical trial for a vertebrogenic-pain pathway distinct from generic discogenic pain. It moved basivertebral ablation from anatomical hypothesis to randomized evidence while defining the continuing questions of replication and transportability.

Cited by wiki pages

  • Overview
  • Discogenic pain and differential
  • Injections and ablative procedures
  • Guidelines
  • Clinical trials landscape
  • Red flags and safety concerns