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

Document Type

Article

Publication Date

10-2-2021

Publication Title

Pain medicine (Malden, Mass.)

Keywords

washington; seattle; swedish neuro; 10kHz; Chronic Low Back Pain; Duty cycling; High-Frequency Stimulation; Pulse dosing; Spinal Cord Stimulation

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 (10kHzSCS) can reduce device recharge time while maintaining efficacy in patients with chronic intractable back pain with/without leg pain.

DESIGN: Prospective, multi-center, observational study.

METHODS: Patients successfully using 10kHzSCS at 100%ON (no PD) for >3-months were consecutively enrolled. After a 1-week Baseline period of documenting their pain twice-daily using 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 where they were requested but not limited to use their most preferred %PD program. Towards 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. Preferences: 39% subjects preferred 3%PD, 32% preferred 14%PD, 10% preferred 50%PD, and 19% preferred 100%ON. Average daily charge durations: 3%PD = 8.3 ± 3.1 min, 14%PD = 13.9 ± 4.9 min, 50% PD = 26.2 ± 7.4 min, 100%ON = 43.8 ± 10.9 min. Regression modeling suggested pain relief was weighted more than twice as influential as charging in preference for reduced %PD.

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

Clinical Institute

Neurosciences (Brain & Spine)

Department

Neurosciences

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