Single‐Center Retrospective Analysis of Device‐Related Complications Related to Dorsal Root Ganglion Stimulation for Pain Relief in 31 Patients

Background: Patients with lumbosacral radicular pain may complain of persisting pain after monopolar pulsed radiofrequency (PRF) treatment. Objective: We evaluated the effect of bipolar PRF stimulation of the dorsal root ganglion (DRG) in patients with chronic lumbosacral radicular pain who were unresponsive to both monopolar PRF stimulation of the DRG and transforaminal epidural steroid injection (TFESI). Study Design: This is a prospective observational study. Setting: The outpatient clinic of a single academic medical center in Korea. Methods: We retrospectively reviewed data from 102 patients who had received monopolar PRF to the DRG for management of lumbosacral radiculopathy. Of these, 32 patients had persistent radicular pain that was scored at least 5 on a numeric rating scale (NRS). Twenty-three of them were included in this study and underwent bipolar PRF of the DRG. The outcomes after the procedure were evaluated using the NRS for radicular pain before treatment and 1, 2, and 3 months after treatment. Successful pain relief was defined as ≥ 50% reduction in the NRS score compared with the score prior to treatment. Furthermore, at 3 months after treatment, patient satisfaction levels were examined. Patients reporting very good (score = 7) or good results (score = 6) were considered to be satisfied with the procedure. Results: The NRS scores changed significantly over time. At 1, 2, and 3 months after bipolar PRF, the NRS scores were significantly reduced compared with the scores before the treatment. Twelve (52.2%) of the 23 patients reported successful pain relief and were satisfied with treatment results 3 months after bipolar PRF. No serious adverse effects were recorded. Limitations: A small number of patients were recruited and we did not perform long-term follow-up. Conclusion: We believe the use of bipolar PRF of the DRG can be an effective and safe interventional technique for chronic refractory lumbosacral radiculopathy. It appears to be a potential option that can be tried before proceeding to spinal surgery. Key words: Bipolar, pulsed radiofrequency, lumbosacral radicular pain, chronic pain, dorsal root ganglion, spinal stenosis, herniated disc

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Mechanism of dorsal root ganglion stimulation for pain relief in painful diabetic polyneuropathy is not dependent on GABA release in the dorsal horn of the spinal cord

CNS Neuroscience & Therapeutics ◽

10.1111/cns.13192 ◽

2019 ◽

Vol 26 (1) ◽

pp. 136-143 ◽

Cited By ~ 9

Author(s):

Eva Koetsier ◽

Glenn Franken ◽

Jacques Debets ◽

Lonne Heijmans ◽

Sander M.J. Kuijk ◽

...

Keyword(s):

Spinal Cord ◽

Pain Relief ◽

Dorsal Root Ganglion ◽

Dorsal Horn ◽

Dorsal Root ◽

Diabetic Polyneuropathy ◽

Gaba Release

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Decreased Opioid Consumption and Durable Pain Relief in Patients Treated with 10 kHz SCS: A Retrospective Analysis of Outcomes from Single-Center

Journal of Pain Research ◽

10.2147/jpr.s312932 ◽

2021 ◽

Vol Volume 14 ◽

pp. 2593-2600

Author(s):

Honghui Feng ◽

Patrick Doherty ◽

Anand Rotte

Keyword(s):

Pain Relief ◽

Retrospective Analysis ◽

Opioid Consumption ◽

Single Center

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Retrospective analysis of complications associated with dorsal root ganglion stimulation for pain relief in the FDA MAUDE database

Regional Anesthesia and Pain Medicine ◽

10.1136/rapm-2018-000007 ◽

2019 ◽

Vol 44 (1) ◽

pp. 100-106 ◽

Cited By ~ 14

Author(s):

Eellan Sivanesan ◽

Mark C Bicket ◽

Steven P Cohen

Keyword(s):

Pain Relief ◽

Dorsal Root Ganglion ◽

Adverse Events ◽

Dorsal Root ◽

New Technology ◽

Safety Data ◽

Secondary Analysis ◽

Freedom Of Information ◽

Serious Adverse Events ◽

Innovative Therapy

Background and objectivesDorsal root ganglion stimulation is an emerging therapy in the treatment of chronic pain. Compared with traditional spinal cord stimulation, it allows a discretely targeted stimulation profile and may act via differing mechanisms of action. Despite these advantages, little is known about the complications associated with this new modality.MethodsWe queried the MAUDE (Manufacturer and User Facility Device Experience) database for all entries named ‘Dorsal root ganglion stimulator for pain relief’ reported between May 1, 2016 and December 31, 2017. We verified these data through the Office of the Freedom of Information Act at the US Food and Drug Administration. We then eliminated duplicate entries and categorized each complication based on the event description. A secondary analysis was performed to characterize the serious adverse events and the severity of new neurologic symptoms and infections.ResultsWe identified 979 unique episodes following our process of deduplication. Almost half (47%) of entries were categorized as device-related complications, a quarter (28%) as procedural complications, with the remainder as patient complaints (12%), serious adverse events (2.4%), and ‘other’ complications (4.6%). The majority of complications were managed surgically with revision (n = 488; 49.8%) rather than explant (n = 161; 16.4%) events, respectively.ConclusionsThe ‘Dorsal root ganglion stimulator for pain relief’ device has been publicized as a breakthrough in neuromodulation technologies. As with any new technology, we must proceed with caution and re-evaluate effectiveness as information becomes available. The MAUDE database has provided safety data unique for this device that will aid in informed consent and further refinement of this innovative therapy.

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