Wireless Neuromodulation for Chronic Back Pain: Delivery of High-Frequency Dorsal Root Ganglion Stimulation by a Minimally Invasive Technique

Abstract

Objective To evaluate the analgesic effect of a dorsal root ganglion (DRG) stimulation technology utilizing high-frequency pulse rates to treat intractable chronic back and leg pain. Methods This case study presents the outcomes, with a novel, wireless, minimally invasive miniature neurostimulator system in a case of chronic back pain. The subject was implanted bilaterally with a Freedom 4A quadripolar electrode array at the L2 dorsal root ganglion. Stimulation was applied using 10 kHz pulse rate and 30 μs pulse width. A VAS pain-rating scale, Oswestry Disability Index (ODI), EQ-5D-5L Quality of Life Questionnaire 5 dimensions, and Patients' Global Impression of Change (PGIC) scale were evaluated at 12 weeks and 6 months post implantation. Results VAS pain scores for back pain reduced from 91 to 31 mms and 80 to 35 mms for leg pain. Additionally, while stimulation remained paresthesia-free, there were a marked decrease in pain medications and an increase in quality of life. Also, an increase in functionality from crippled to moderate was reported. There were no adverse reactions related to the procedure or device. Conclusion The minimally invasive, wireless approach to deliver high-frequency, paresthesia-free DRG stimulation for treatment of chronic back and leg pain associated with FBSS was effective and encouraging.

Dorsal Root Ganglion Stimulation in Experimental Painful Diabetic Polyneuropathy: Delayed Wash-Out of Pain Relief After Low-Frequency (1Hz) Stimulation

“…Until now there is little data about the use of HF for DRGS. Nevertheless, one case report and one pilot study ( n = 5) applying HF‐DRGS (2‐10 kHz) in the treatment of chronic back pain, have shown positive results.…”

<p>Neuromodulation with electrical field stimulation of dorsal root ganglion in various pain syndromes: a systematic review with focus on participant selection</p>

“…Included studies analyzed the following painful conditions: CRPS,1–3,31–36 LBP,5,6,37–40 groin pain,7,8,41 pelvic girdle pain,9,10 peripheral neuropathy,29,30,42 peripheral diabetic neuropathy,43 phantom limb pain,44 chronic intractable pain in the coccyx,45 chronic testicular pain,46 anterior cutaneous nerve entrapment syndrome (ACNES),47 loin pain hematuria syndrome (LPHS) 48…”

“…Two studies in this group were case reports that used a novel high-frequency type of neuromodulation with EFS with parameters of stimulation different from standard DRG stimulation. One was case report including only one patient with fixed stimulation parameters that showed 66% improvement for back pain and 56% for leg pain at 6 months followup 5. The other was a small feasibility study that included six participants and used a range of stimulation parameters, specifically amplitude between 1 and 24 mA, pulse width of 10–1000 µs, and frequency of 2–10,000 Hz.…”

“…Since our search is dated September 2018, we included several painful conditions that have been treated with DRG EFS neuromodulation for the first time such as chronic intractable pain in the coccyx,45 ACNES,47 and LPHS 48. We also included small pilot studies and case reports that used novel high-frequency parameters of stimulation 5,39…”

Design and Analysis of a Whole-Body Noncontact Electromagnetic Subthreshold Stimulation Device with Field Modulation Targeting Nonspecific Neuropathic Pain

“…For our purpose, we decided to reconstruct that design for a much lower frequency band of 100 kHz or less. In particular, the band of 10 kHz has recently demonstrated great promise for spinal cord stimulation for back and leg chronic pain management [55][56][57][58][59][69][70][71][72][73][74][75][76][77] with and without previous back surgeries [70,72], and is utilized by TENS [78]. In addition to superior pain relief, the 10 kHz band may provide long-term improvements in quality of life and functionality for subjects with chronic low back and leg pain [77].…”