Background: The role of stimulation parameters, especially stimulation frequency is not well understood in dorsal root ganglion stimulation. Previous studies documented higher effectiveness for frequencies as low as 20 Hz, but there is evidence that even lower values could lead to better outcomes. In this study, we investigate the influence of low-frequency DRG-S.
Method: This is a randomized double-blind clinical trial with a crossover design. Patients with an already implanted DRG-S system were included and randomly tested with 4 Hz, 20 Hz, 60 Hz, and sham stimulation. Amplitude was adjusted to subthreshold values for each frequency. Each frequency was tested for 5 days, followed by a 2-day washout period. Patients were assessed using VAS, McGill Pain Questionnaire, EQ-5D-5L, and Beck Depression Inventory.
Results: Seventeen patients were in included. Time between inclusion in this study and primary implant was 32.8 months. Baseline stimulation frequency was 20 Hz in all patients. Mean baseline pain intensity was VAS 3.2 (SD 2.2). With 4-Hz stimulation, VAS was 3.8 (SD 1.9), with 20 Hz VAS 4.2 (SD 2.0) and with 60 Hz VAS 4.6 (SD 2.7). Worst pain control was seen with sham stimulation with a VAS of 5.3 (SD 3.0). Stimulation with 4 Hz achieved lower VAS scores, but this was only statistically significant when compared to sham (p = 0.001). A similar trend favoring 4-Hz stimulation was seen using the Beck Depression Inventory, but in this case no statistical significance was found. Outcomes of McGill Pain Questionnaire and EQ-5D-5L favored 20 Hz stimulation, but again without statistical significance.
Conclusions: Low-frequency stimulation was not significantly better than classic 20-Hz stimulation in relieving pain intensity; the study might however be underpowered. Longer washout and observational periods might also be necessary to show clear differences in frequency response.
Keywords: Dorsal root ganglion stimulation; Frequency; Neuromodulation; Neuropathic pain; Nociceptive pain.
© 2023. The Author(s).