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