Implanted nerve stimulation cuts pain by half, study confirms
A rigorous clinical trial shows that subperception dorsal root ganglion stimulation—a minimally invasive implant that sends electrical pulses to nerve clusters—significantly reduces chronic nerve pain without causing sensation. The finding validates a growing market for implantable pain devices and provides insurers and hospital systems with rare, gold-standard evidence for reimbursement decisions.
Originaltitel: Subperception dorsal root ganglion stimulation versus sham stimulation in established responders: a randomized, double-blind crossover clinical trial
Background subperception (paresthesia-free) dorsal root ganglion (DRG) stimulation is increasingly used for focal neuropathic pain, but sham-controlled evidence remains limited. We conducted a randomized, double-blind, sham-controlled crossover trial with enriched enrollment design in established DRG-stimulation responders. Methods In this single-center trial, adults with chronic peripheral neuropathic or nociplastic pain with implanted DRG system and sustained response (≥50% pain reduction for ≥3 months on stable stimulation settings and medication) were randomized 1:1 to active→sham or sham→active stimulation. Participants completed two 5-day treatment periods separated by a 24-hour washout with stimulation off. Active stimulation was delivered at 90% of the perception threshold, and sham was stimulation off. The primary outcome was median pain intensity on a 0–10 Numeric Rating Scale (NRS). Secondary outcomes included patient satisfaction and Patient Global Impression of Change (PGIC) domains. Analyses used Wilcoxon signed-rank tests with Hodges-Lehmann estimates. Results In 20 randomized patients, pain intensity was lower during active than sham stimulation (median NRS 3.0 (IQR 2.0–4.0) vs 6.0 (IQR 4.0–7.0); Hodges-Lehmann median difference, −2.5; 95% CI −3.0 to −2.0; p<0.001). Patient satisfaction and all PGIC domains favored active stimulation. Two participants terminated one treatment period early per prespecified criteria; available data were retained. No serious or device-related adverse events were reported. Conclusions In established DRG responders, subperception DRG stimulation produced clinically meaningful pain reduction and improved patient-reported outcomes compared with sham. These findings support efficacy during the maintenance phase of treatment, but their generalizability to unselected chronic pain populations or earlier treatment phases is limited. Trial registration number NCT07170722 .