Regional anesthesia and pain medicine · 2026
Subperception dorsal root ganglion stimulation versus sham stimulation in established responders: a randomized, double-blind crossover clinical trial.
СтатьяНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Tabatabaei Pedram, Wänman Johan, Awad Amar, Eriksson Maria, Salomonsson Josef, Bredemo Linda, Sjöberg Rickard, Hariz Marwan I, Blomstedt Patric
Аннотация
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.
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.