Dorsal Root Ganglion Stimulation Used for the Treatment of Chronic Neuropathic Pain in the Groin: A Single-Center Study With Long-Term Prospective Results in 34 Cases

Morgalla, Matthias; Bolat, Anil; Fortunato, Marcos; Lepski, Guilherme; Chander, Bankim Subhash

doi:10.1111/ner.12713

Cited by 57 publications

(57 citation statements)

References 35 publications

(36 reference statements)

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“…The overall incidence rate of 3.2% for DRG stimulation was comparable to the event rate for fully‐implantable SCS systems (3.1%) from the same manufacturer and so represents a true comparison of rates given that the same requirements for reporting and methods for data collection were taken as a part of the required device vigilance monitoring. These rates are similar to those observed during the ACCURATE clinical trial conducted for FDA approval as well as those reported in the literature . The latter of these two data collection methods (clinical studies) yield fairly large ranges of events, mostly due to the heterogeneity in data collection methods, reporting decisions and the fact that data was obtained from different geographies as well as different clinical sites.…”

Section: Discussionsupporting

confidence: 83%

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Safety Analysis of Dorsal Root Ganglion Stimulation in the Treatment of Chronic Pain

Deer

Pope

Hunter

et al. 2020

Neuromodulation: Technology at the Neural Interface

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Background Stimulation of the dorsal root ganglion (DRG) in the treatment of chronic, intractable pain has shown excellent clinical results in multiple published studies, including a large prospective, randomized, controlled trial. Both safety and efficacy have been demonstrated utilizing this therapeutic approach for many chronic complaints. Continued assessment of neuromodulation therapies, such as DRG stimulation, are not only an important aspect of vigilant care, but are also necessary for the evaluation for safety. Materials and Methods Safety and complaint records for DRG and spinal cord stimulation (SCS) stimulation were obtained from the manufacturer, analyzed and compiled to further assess ongoing device safety. Complaint event data were stratified according to complain type as well as overall rates. Data from similar time periods were compared between epidural neurostimulation devices by the same manufacturer as well as rates reported in the literature. Results Overall, DRG stimulation device event rates were lower or comparable to similar epidurally placed neurostimulation devices. Rates of events varied from 0 to 1.0% for DRG stimulation (n >500+ implants) which was similar to the event rate for SCS by the same manufacturer (n >2000+ implants). In comparison, complaints and adverse events ranged from 0 to 14% for SCS in the literature. Discussions The current results from a large consecutive cohort obtained from manufacturer records indicates that DRG stimulation demonstrates an excellent safety profile. Reported event rates are similar to previously reported adverse event and complaint rates in the literature for this therapy. Similarly, safety events rates were lower or similar to previously reported rates for SCS, further demonstrating the comparative safety of this neuromodulation technique for chronic pain treatment.

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Section: Discussionsupporting

confidence: 83%

“…Clinically, it has been shown in multiple, published studies that DRG stimulation produces significant analgesia in patients suffering from chronic pain . This includes results from a large, prospective, multi‐center, randomized controlled trial (ACCURATE study) in which DRG stimulation was shown to be safe and effective .…”

Section: Introductionmentioning

confidence: 99%

Safety Analysis of Dorsal Root Ganglion Stimulation in the Treatment of Chronic Pain

Deer

Pope

Hunter

et al. 2020

Neuromodulation: Technology at the Neural Interface

View full text Add to dashboard Cite

show abstract

“…Advantages of the method include lower occurrence of paresthesias, independence from body spatial position, and very low electrical current consumption . However, the electrodes used in DRGS are thinner and more flexible than those of traditional spinal cord stimulation (SCS), which may lead to a higher rate of electrode fracture . This complication has happened in two of our subjects.…”

Section: Discussionmentioning

confidence: 99%

“…Deer et al reported a 74.2% success rate at the 12-month evaluation and significant improvement in all SF-36 scores and BPI scores in a DRGS randomized trial (27). Morgalla et al reported 63.5% overall pain relief and improvement in BPI scores under DRGS in patients with post-herniorraphy inguinal pain, which was sustained even after three years of observation (14). These successful rates of pain relief have been replicated in other more recent smaller case series (11,55,56) as well as in some case reports (13,16,18,19,26).…”

Section: Drg Stimulationmentioning

confidence: 99%