Kaare Meier

Complications and Effects of Dorsal Root Ganglion Stimulation in the Treatment of Chronic Neuropathic Pain: A Nationwide Cohort Study in Denmark

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Complications and Effects of Dorsal Root Ganglion Stimulation in the Treatment of Chronic Neuropathic Pain : A Nationwide Cohort Study in Denmark. / Horan, Mattias; Jacobsen, Anne Helene; Scherer, Christian; Rosenlund, Christina; Gulisano, Helga Angela; Søe, Morten; Sørensen, Jens Christian Hedemann; Meier, Kaare; Blichfeldt-Eckhardt, Morten Rune.

In: Neuromodulation, 06.2020.

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Horan, Mattias ; Jacobsen, Anne Helene ; Scherer, Christian ; Rosenlund, Christina ; Gulisano, Helga Angela ; Søe, Morten ; Sørensen, Jens Christian Hedemann ; Meier, Kaare ; Blichfeldt-Eckhardt, Morten Rune. / Complications and Effects of Dorsal Root Ganglion Stimulation in the Treatment of Chronic Neuropathic Pain : A Nationwide Cohort Study in Denmark. In: Neuromodulation. 2020.

Bibtex

@article{ab568dd0ee8f443fa972e7b1dd8d75fe,
title = "Complications and Effects of Dorsal Root Ganglion Stimulation in the Treatment of Chronic Neuropathic Pain: A Nationwide Cohort Study in Denmark",
abstract = "Objectives: Dorsal root ganglion (DRG) stimulation is a novel treatment of chronic neuropathic pain and has been shown to be efficacious across several case reports and randomized trials. However, long-term follow-up is limited, as are reports of complication rates. This study presents efficacy and complications for patients treated with DRG stimulation. Materials and Methods: We performed an observational, multicenter cohort study of all patients in Denmark implanted with FDA-approved DRG stimulation systems to treat chronic, neuropathic pain between 2014 and 2018. Follow-up period was one to three years. Results: Forty-three patients underwent trial DRG stimulation; 33 were subsequently fully implanted. Pain location: 58% lower extremity; 21% upper extremity; 21% thoracic/abdominal. At the end of the observation period, 58% of fully implanted patients were still implanted; 42% had fully functional systems. In these patients, average Numerical Rating Scale (NRS)-score of pain was reduced from 6.8 to 3.5 (p = 0.00049) and worst NRS-score was reduced from 8.6 to 6.0 (p = 0.0039) at 12 months follow-up. Pain Catastrophizing Score was reduced from 32 to 15 (p = 0.0039). Thirteen patients experienced complications related to defect leads (39% of implanted systems). In four patients (12%), lead removal left fragments in the root canal due to lead fracture, and three patients suffered permanent nerve damage during attempts to replace broken leads. Conclusions: This study suggests a significant, clinically relevant effect of DRG stimulation on neuropathic pain, but also demonstrates substantial problems with maintenance and revision of currently available systems. Consequently, treatment with equipment marketed specifically for DRG stimulation is currently paused in Denmark.",
keywords = "Chronic pain, complications, DRG stimulation, efficacy, neuromodulation",
author = "Mattias Horan and Jacobsen, {Anne Helene} and Christian Scherer and Christina Rosenlund and Gulisano, {Helga Angela} and Morten S{\o}e and S{\o}rensen, {Jens Christian Hedemann} and Kaare Meier and Blichfeldt-Eckhardt, {Morten Rune}",
year = "2020",
month = jun,
doi = "10.1111/ner.13171",
language = "English",
journal = "Neuromodulation: Technology at the Neural Interface",
issn = "1094-7159",
publisher = "Wiley-Blackwell Publishing, Inc.",

}

RIS

TY - JOUR

T1 - Complications and Effects of Dorsal Root Ganglion Stimulation in the Treatment of Chronic Neuropathic Pain

T2 - A Nationwide Cohort Study in Denmark

AU - Horan, Mattias

AU - Jacobsen, Anne Helene

AU - Scherer, Christian

AU - Rosenlund, Christina

AU - Gulisano, Helga Angela

AU - Søe, Morten

AU - Sørensen, Jens Christian Hedemann

AU - Meier, Kaare

AU - Blichfeldt-Eckhardt, Morten Rune

PY - 2020/6

Y1 - 2020/6

N2 - Objectives: Dorsal root ganglion (DRG) stimulation is a novel treatment of chronic neuropathic pain and has been shown to be efficacious across several case reports and randomized trials. However, long-term follow-up is limited, as are reports of complication rates. This study presents efficacy and complications for patients treated with DRG stimulation. Materials and Methods: We performed an observational, multicenter cohort study of all patients in Denmark implanted with FDA-approved DRG stimulation systems to treat chronic, neuropathic pain between 2014 and 2018. Follow-up period was one to three years. Results: Forty-three patients underwent trial DRG stimulation; 33 were subsequently fully implanted. Pain location: 58% lower extremity; 21% upper extremity; 21% thoracic/abdominal. At the end of the observation period, 58% of fully implanted patients were still implanted; 42% had fully functional systems. In these patients, average Numerical Rating Scale (NRS)-score of pain was reduced from 6.8 to 3.5 (p = 0.00049) and worst NRS-score was reduced from 8.6 to 6.0 (p = 0.0039) at 12 months follow-up. Pain Catastrophizing Score was reduced from 32 to 15 (p = 0.0039). Thirteen patients experienced complications related to defect leads (39% of implanted systems). In four patients (12%), lead removal left fragments in the root canal due to lead fracture, and three patients suffered permanent nerve damage during attempts to replace broken leads. Conclusions: This study suggests a significant, clinically relevant effect of DRG stimulation on neuropathic pain, but also demonstrates substantial problems with maintenance and revision of currently available systems. Consequently, treatment with equipment marketed specifically for DRG stimulation is currently paused in Denmark.

AB - Objectives: Dorsal root ganglion (DRG) stimulation is a novel treatment of chronic neuropathic pain and has been shown to be efficacious across several case reports and randomized trials. However, long-term follow-up is limited, as are reports of complication rates. This study presents efficacy and complications for patients treated with DRG stimulation. Materials and Methods: We performed an observational, multicenter cohort study of all patients in Denmark implanted with FDA-approved DRG stimulation systems to treat chronic, neuropathic pain between 2014 and 2018. Follow-up period was one to three years. Results: Forty-three patients underwent trial DRG stimulation; 33 were subsequently fully implanted. Pain location: 58% lower extremity; 21% upper extremity; 21% thoracic/abdominal. At the end of the observation period, 58% of fully implanted patients were still implanted; 42% had fully functional systems. In these patients, average Numerical Rating Scale (NRS)-score of pain was reduced from 6.8 to 3.5 (p = 0.00049) and worst NRS-score was reduced from 8.6 to 6.0 (p = 0.0039) at 12 months follow-up. Pain Catastrophizing Score was reduced from 32 to 15 (p = 0.0039). Thirteen patients experienced complications related to defect leads (39% of implanted systems). In four patients (12%), lead removal left fragments in the root canal due to lead fracture, and three patients suffered permanent nerve damage during attempts to replace broken leads. Conclusions: This study suggests a significant, clinically relevant effect of DRG stimulation on neuropathic pain, but also demonstrates substantial problems with maintenance and revision of currently available systems. Consequently, treatment with equipment marketed specifically for DRG stimulation is currently paused in Denmark.

KW - Chronic pain

KW - complications

KW - DRG stimulation

KW - efficacy

KW - neuromodulation

UR - http://www.scopus.com/inward/record.url?scp=85086463644&partnerID=8YFLogxK

U2 - 10.1111/ner.13171

DO - 10.1111/ner.13171

M3 - Journal article

C2 - 32539189

AN - SCOPUS:85086463644

JO - Neuromodulation: Technology at the Neural Interface

JF - Neuromodulation: Technology at the Neural Interface

SN - 1094-7159

ER -