Subcutaneous placement of electrodes with our minimally invasive technique and wireless neuromodulation technology was safe and effective. Significant improvements in pain relief ensued, and no further adverse events had been reported at the end of 3 months' follow-up.

Wireless high-frequency stimulation of the DRG is a viable option to treat chronic low back pain. Preliminary results show a subject preference for stimulation at the T9 vertebral level.

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.

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