A prospective long-term follow-up of dorsal root ganglion stimulation for the management of chronic intractable pain

Abstract

Initial clinical studies have shown that the stimulation of the dorsal root ganglion (DRG) can significantly reduce chronic intractable pain. However, clinical data on long-term results and complications of these systems are limited. The aim of this prospective study is to report on a single center long-term follow-up of DRG stimulation for intractable chronic pain. Participants were implanted with DRG stimulation devices between 2013 and 2015 with an observation period of 24 months. Patients were contacted again in 2020 for a final follow-up (ie, between 5 and 7 years postimplantation). Forty-two participants were recruited, of whom 32 received the fully implantable pulse generator (IPG). At the final follow-up, 50% (16/32) of participants were still using DRG stimulation. Two participants still had the original IPG and 14 had received a replacement IPG. Pain scores were significantly reduced at 24 months, mean difference 1.7 (95% confidence interval: 0.2-3.3, P 5 0.03), and at the last follow-up, mean difference 2.1 (95% confidence interval: 0.3-4, P 5 0.03). Significant improvements were observed for health-related quality of life. The findings were generally robust to imputation methods of missing data. Implantable pulse generators of 8 patients were explanted because of dissatisfaction with pain relief. In conclusion, DRG stimulation can provide effective pain relief and improved quality of life in patients suffering with neuropathic pain, although this study had a revision rate of 42% within the first 24 months, and 56% of IPGs that were replaced because of battery depletion had a shorter than expected battery life.

Does a Screening Trial for Spinal Cord Stimulation in Patients With Chronic Pain of Neuropathic Origin Have Clinical Utility (TRIAL-STIM)? 36-Month Results From a Randomized Controlled Trial

“…Despite many advances in SCS waveforms, 16 - 18 target neural tissue, 19 , 20 and feedback technology, 6 common to all RCTs to date is that patients are required to undergo a screening trial to evaluate early response to therapy before full implantation of the SCS device. Screening trials are recommended by clinical guidelines and regulators including the Food and Drug Administration (FDA) in the United States.…”

Trends in spinal cord stimulation utilization: change, growth and implications for the future

“…Pulse generators had been explanted in 8 patients because of dissatisfaction with pain relief. The patients in this study had a revision rate of 42% within the first 24 months and 56% of the IPG that were replaced due to battery depletion had a shorter than expected battery life 19. Hines et al examined outcomes in a single-center retrospective analysis of device-related complications related to DRG stimulation for pain relief in 31 patients.…”

Best Practices for Dorsal Root Ganglion Stimulation for Chronic Pain: Guidelines from the American Society of Pain and Neuroscience

“…224 Similarly, earlier studies used paresthesia-based programming with frequencies similar to SCS, leading to a battery depletion time which was similar to an SCS non-rechargeable IPG. 72,225,226 And the initial lead iteration contained a "ball tip" lead that was prone to dislocation, adding to the hardware complications. Lead migration and fracture mitigation via lead anchoring is discussed below.…”