Ruishenan Medical Hosts Seminar on High-Frequency (10kHz) and Low-Frequency Spinal Cord Stimulation for Diabetic Peripheral Neuropathy

What is 10kHz Ultra-High Frequency Spinal Cord Stimulation Therapy?

10kHz SCS Electrode Placement

Traditional SCS requires doctors to spend time adjusting the electrode position during surgery and conducting intraoperative tests with the help of technicians, engaging in verbal communication with patients to discuss sensations, ensuring that the stimulation from the electrodes covers the patient’s pain area. In contrast, with 10kHz therapy, electrode implantation is anatomy-based. After placing the electrodes, impedance is checked to ensure the integrity of the stimulation system, and it is only necessary to verify that the electrodes are located in the epidural space before completing the surgery. There is no need to check paresthesia coverage during the operation, allowing the patient to remain continuously sedated, improving the surgical process and increasing patient comfort.

10kHz Therapy: For lower back or leg pain, electrodes are typically placed from T8 to T11, with the anatomical target position located at the T9/10 intervertebral disc. Russo^[1]According to experience, for patients with lower back and leg pain, the first contact of one electrode is usually placed at the top of the T8 vertebra, and the last contact of the second electrode is placed at the bottom of the T11 vertebra, with some overlap of the electrode leads at the T9/T10 intervertebral disc. For neck and arm pain, the C2/3 intervertebral disc and C3-C4 vertebrae are selected based on the clinician’s experience.

10kHz SCS Parameter Settings

Patients using 10kHz therapy have a pulse frequency of 10,000 Hz and a pulse width of 30 μs. A treatment plan usually lasts for 24 hours, and if the efficacy is poor, another plan is adopted (the main adjustment of the plan involves electrode contact). If pain relief exceeds 50% during the 10kHz therapy trial period, implantation of a permanent pulse generator can be considered.

Comparison Table of 10kHz SCS and Traditional SCS^[1]

10kHz SCS Effectively Treats Painful Diabetic Neuropathy

In 2022, Petersen^[2]Reported that in the study conducted by their research team on 10kHz spinal cord stimulation therapy for treating PDN, compared with conventional medical management (CMM), 10kHz treatment provided significant and sustained pain relief for PDN patients. Key findings at 12 months: 85% responder rate, 74% average pain reduction, 66% neurological improvement, and 92% of patients were very satisfied or satisfied with the therapy among those receiving 10kHz spinal cord stimulation therapy (including crossover arm). Additionally, 10kHz SCS treatment significantly improved patients' overall health-related quality of life (HRQoL).

In August 2023, the research team reported the results of the SENZA-PDN study after 24 months of 10kHz SCS treatment.^[3]Further Discussion on the Long-term Safety and Efficacy of 10kHz SCS in Treating PDN. At the 24-month follow-up, compared with baseline, 10kHz SCS treatment reduced pain by an average of 79.9% in PDN patients, with 90.1% of patients experiencing pain relief ≥50%. Significant improvements were observed in HRQoL scores and sleep (P<0.001), and 65.7% of patients showed clinically meaningful improvements in neurological function.

10kHz SCS Effectively Relieves Leg and Back Pain

The First Clinical Study of 10kHz SCS^[4]A feasibility study was conducted on 24 patients with chronic back pain at five centers in the United States, who were candidates for traditional SCS. After undergoing a 4-day trial of traditional SCS, the patients then underwent a 4-day trial of 10kHz SCS. Compared to baseline, patients in this study who received 10kHz SCS showed significant improvements in VAS pain scores (8.68-2.03 [P<0.001]) and back pain scores (8.12-1.88 [P<0.001]). 87.5% (21 patients) preferred 10kHz SCS treatment over conventional treatment.

Kapural^[5]The pivotal RCT on 10kHz spinal cord stimulation (SCS) for treating low back and leg pain conducted by et al. demonstrated that 10kHz SCS outperformed traditional SCS in both the number of responsive patients and treatment efficacy. Its success rate in treating back pain was nearly double that of conventional SCS, and its success rate for leg pain was 1.5 times higher. Moreover, all patients in the trial had previously failed conventional medical management over an average of 8 years. After receiving 10kHz SCS treatment for 12 months post-implantation, they experienced significant improvements in pain, disability, and quality of life.

10kHz SCS for the Treatment of Chronic Upper Limb and Neck Pain

Amirdelfan^[6]A prospective multicenter study on 10kHz high-frequency spinal cord stimulation for the treatment of neck and arm pain was conducted. 86.7% of the subjects achieved the primary endpoint (≥50% pain relief at 3 months). Compared with baseline, the average VAS scores for neck pain (7.6±0.2 cm vs 1.5±0.3 cm) and upper limb pain (7.1±0.3 cm vs 1.0±0.2 cm) were significantly reduced at the 12-month evaluation (P<0.001). At the 12-month assessment, 89.2% of patients with neck pain and 95.0% of patients with upper limb pain experienced ≥50% pain relief from baseline, 95.0% reported being "satisfied/very satisfied," and 30.0% of patients discontinued or reduced their opioid usage.

Russo^[7]A retrospective study reviewed 256 patients treated with 10kHz SCS for chronic intractable pain of various etiologies. Pain distributions included back + leg, back, head ± neck, and neck ± arm/shoulder. Approximately 30% of the patients had previously used conventional low-frequency stimulation but failed. Among the 256 patients, 73% underwent permanent implantation, and patients with back + leg pain showed the highest success rate (81%) after receiving 10kHz SCS treatment. In patients with available data, 50% experienced pain reduction at 6 months post-surgery. Sixty-eight percent of patients who had failed traditional SCS reported a response, with an average pain relief of 49% at 6 months (P<0.001). After 6 months, the ODI decreased by 8.6 points (21%), improving tolerance for sitting, standing, and walking.

10kHz SCS for the Treatment of Chronic Pelvic Pain (CPP)