Mattias Horan1,2, Anne Helene Jacobsen1, Christian Scherer1,3, Christina Rosenlund1, Helga Angela Gulisano4, Morten Søe1, Jens Christian Hedemann Sørensen5, Kaare Meier5,6, Morten Rune Blichfeldt-Eckhardt1,2,3. 1. Department of Neurosurgery, Odense University Hospital, Odense, Denmark. 2. Department of Clinical Research, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark. 3. Department of Anesthesiology and Intensive Care, Odense University Hospital, Odense, Denmark. 4. Department of Neurosurgery, Aalborg University Hospital, Aalborg, Denmark. 5. Department of Neurosurgery, Aarhus University Hospital, Aarhus, Denmark. 6. Department of Anesthesiology and Intensive Care, Aarhus University Hospital, Aarhus, 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.
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.
Authors: Ashley N Dalrymple; Jordyn E Ting; Rohit Bose; James K Trevathan; Stephan Nieuwoudt; Scott F Lempka; Manfred Franke; Kip A Ludwig; Andrew J Shoffstall; Lee E Fisher; Douglas J Weber Journal: J Neural Eng Date: 2021-11-04 Impact factor: 5.379
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