Pain medicine

Subperception dorsal root ganglion stimulation versus sham stimulation in established responders: a randomized, double-blind crossover clinical trial

Reg Anesth Pain MedPublished Randomised controlled trial

Primary resultResult — go to the resultHodges-Lehmann median difference −2.5 NRS 95% CI −3.0 to −2.0
  • Two participants terminated one treatment period early per prespecified criteria; available data retained

Authors' conclusion

In established DRG responders, subperception DRG stimulation produced clinically meaningful pain reduction and improved patient-reported outcomes compared with sham.

Study context

Population
Adults with chronic peripheral neuropathic or nociplastic pain, implanted dorsal root ganglion (DRG) system and sustained response (≥50% pain reduction for ≥3 months)randomized
Participants
20 adults
Comparison
Subperception DRG stimulation vs sham
Primary endpoint
Median pain intensity on 0-10 Numeric Rating Scale (NRS)
Methodological detailsdouble-blind, sham-controlled, crossover, enriched enrollment, single-centre
  • Double-blind
  • Sham-controlled
  • Crossover
  • Enriched enrollment
  • Single-centre

Primary result

As reported in the abstract

Hodges-Lehmann median difference

−2.5 NRS

95% CI −3.0 to −2.0

P < 0.001

By group

Active vs Sham
Hodges-Lehmann median difference −2.5 NRS (95% CI −3.0 to −2.0); P < 0.001

Secondary outcomes

Patient satisfaction and all Patient Global Impression of Change (PGIC) domains favored active stimulation

Safety

No serious or device-related adverse events reported

Original publication

Subperception dorsal root ganglion stimulation versus sham stimulation in established responders: a randomized, double-blind crossover clinical trial. Reg Anesth Pain Med. Published 13 May 2026. doi:10.1136/rapm-2026-107906

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