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Provenzano D, Tate J, Gupta M, et al. Pulse Dosing of 10-kHz Paresthesia-Independent Spinal Cord Stimulation Provides the Same Efficacy with Substantial Reduction of Device Recharge Time. Pain Med. 2022;23(1):152-163doi: 10.1093/pm/pnab288.
Provenzano, D., Tate, J., Gupta, M., Yu, C., Verrills, P., Guirguis, M., Harrison, N., Smith, T., Azalde, R., & Bradley, K. (2022). Pulse Dosing of 10-kHz Paresthesia-Independent Spinal Cord Stimulation Provides the Same Efficacy with Substantial Reduction of Device Recharge Time. Pain medicine (Malden, Mass.), 23(1), 152-163. https://doi.org/10.1093/pm/pnab288
Provenzano, David, et al. "Pulse Dosing of 10-kHz Paresthesia-Independent Spinal Cord Stimulation Provides the Same Efficacy with Substantial Reduction of Device Recharge Time." Pain medicine (Malden, Mass.) vol. 23,1 (2022): 152-163. doi: https://doi.org/10.1093/pm/pnab288
Provenzano D, Tate J, Gupta M, Yu C, Verrills P, Guirguis M, Harrison N, Smith T, Azalde R, Bradley K. Pulse Dosing of 10-kHz Paresthesia-Independent Spinal Cord Stimulation Provides the Same Efficacy with Substantial Reduction of Device Recharge Time. Pain Med. 2022 Jan 03;23(1):152-163. doi: 10.1093/pm/pnab288. PMID: 34601597; PMCID: PMC8723142.
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Pain Med. 2022 Jan 03;23(1):152-163. doi: 10.1093/pm/pnab288.

Pulse Dosing of 10-kHz Paresthesia-Independent Spinal Cord Stimulation Provides the Same Efficacy with Substantial Reduction of Device Recharge Time.

Pain medicine (Malden, Mass.)

David Provenzano, Jordan Tate, Mayank Gupta, Cong Yu, Paul Verrills, Maged Guirguis, Nathan Harrison, Thomas Smith, Rose Azalde, Kerry Bradley

Affiliations

  1. Pain Diagnostics & Interventional Care, Sewickley, Pennsylvania, USA.
  2. Alliance Spine & Pain Centers, Atlanta, Georgia, USA.
  3. Neuroscience Research Center, Overland Park, Kansas, USA.
  4. Swedish Medical Center, Seattle, Washington, USA.
  5. Metro Pain Group, Clayton, VIC, Australia.
  6. Ochsner Medical Center, New Orleans, Louisiana, USA.
  7. Guy's and St. Thomas' Hospital NHS Trust, London, UK.
  8. Nevro Corporation, Redwood City, California, USA.

PMID: 34601597 PMCID: PMC8723142 DOI: 10.1093/pm/pnab288

Abstract

OBJECTIVE: This study was designed to assess whether using pulse dosing (PD) (regularly cycled intermittent stimulation) of high-frequency 10-kHz spinal cord stimulation (10-kHz SCS) can reduce device recharge time while maintaining efficacy in patients with chronic intractable back pain with or without leg pain.

DESIGN: Prospective, multicenter, observational study.

METHODS: Patients successfully using 10-kHz SCS at 100%ON (i.e., continuously with no PD) for >3 months were consecutively enrolled. After a 1-week baseline period of documenting their pain twice daily on a 0-10 numerical rating scale (NRS) using 100%ON of their "favorite" program, all subjects were reprogrammed to 14%PD for 10-14 days. If subjects preferred 14%PD to 100%ON, they were programmed to 3%PD; otherwise, they were programmed to 50%PD. Subjects used this next program for another 10-14 days. Subjects then entered a 3-month observational period during which they were requested to use but not limited to their most preferred %PD program. Toward the end of 3 months, subjects completed a 7-day NRS diary and indicated a final %PD program preference. Study endpoints included %PD preference, mean diary NRS by %PD, and daily minutes and patterns of charging.

RESULTS: Of 31 subjects completing the study, 81% preferred less than 100%ON. Among the subjects, 39% preferred 3%PD, 32% preferred 14%PD, 10% preferred 50%PD, and 19% preferred 100%ON. Average daily charge durations were 8.3 ± 3.1 minutes for 3%PD, 13.9 ± 4.9 minutes for 14%PD, 26.2 ± 7.4 minutes for 50%PD, and 43.8 ± 10.9 minutes for 100%ON. Regression modeling suggested that pain relief was weighted as more than twice as influential as charging in preference for reduced %PD.

CONCLUSIONS: This prospective study suggests that 10-kHz SCS therapy with PD may be successfully used in a large majority of 10-kHz SCS responders, maintaining efficacy while reducing device charging time by nearly two thirds.

© The Author(s) 2021. Published by Oxford University Press on behalf of the American Academy of Pain Medicine.

Keywords: 10 kHz; Chronic Low Back Pain; Duty Cycling; High-Frequency Stimulation; Pulse Dosing; Spinal Cord Stimulation

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