Ten kilohertz SCS for Treatment of Chronic Upper Extremity Pain (UEP): Results from Prospective Observational Study

Abstract

Background: Chronic upper extremity pain (UEP) has complex etiologies and is often disabling. It has been shown that 10 kHz SCS can provide paresthesia-free and durable pain relief in multiple pain types and improve the quality of life of patients.

Objective: To gain additional evidence on the safety and effectiveness of 10 kHz SCS for the treatment of chronic UEP.

Study design: It was a prospective, multicenter, and observational study. The study was registered on ClinicalTrials.gov prospectively (clinical trial identifier: NCT02703818).

Setting: Multicenter.

Patients intervention and main outcomes: A total of 43 subjects with chronic UEP of ≥5 cm (on a 0-10 cm visual analog scale; VAS) underwent a trial of 10 kHz SCS, and subjects with ≥40% pain relief received a permanent implant. All subjects had upper limb pain at baseline, while some had concomitant shoulder or neck pain. Subject outcomes were assessed for 12 months, and the primary outcome was the responder rate (percentage of subjects experiencing ≥50% pain relief from baseline) at three months.

Results: Thirty-eight subjects successfully completed the trial (88.3% success rate), 33 received permanent implants (five withdrew consent), and 32 had device activation (per protocol population). There were no paresthesias or uncomfortable changes in stimulation related to changes in posture during the study and there were no neurological deficits. Responder rates at 12 months for upper limb, shoulder, and neck pain in per protocol population (N=32) were 78.1%, 85.2%, and 75.0%, respectively. At 12 months, 84.4% of subjects were satisfied or very satisfied with 10 kHz SCS, and 38.7% either reduced or eliminated opioid usage.

Conclusion: This study further supports the effectiveness of 10 kHz SCS for chronic UEP treatment and documents the safety profile of the therapy.

Clinical trial identifier: NCT02703818.

Keywords: 10 kHz SCS; VAS; shoulder and upper limb pain; upper extremity pain.

Conflict of interest statement

Dr Kosek received research grants from Boston Scientific and Nevro Corp. Dr Rosen is a consultant to and received research grants from Flowonix, Saluda Medical, Biotronik, Medtronic, and Nevro. Dr Bromberg is a consultant and investor in Nevro and Mudjala. He also reports clinical educator/speakership from Medtronic, outside the submitted work. Dr Gulve is a consultant to Nevro Corp., Saluda Medical and received research grants from Boston Scientific, Abbott, Medtronic, and Mainstay Medical. Dr Esposito is a consultant to Nevro Corp., Abbott, Boston Scientific, Flowonix, and Vertiflex. Dr McRoberts is a consultant to Abbott. Dr Rotte is an employee of Nevro Corp. Mr Gliner was an employee of Nevro Corp. at the time the study was conducted and is now an independent consultant, Seattle, WA, USA. Dr Maneshi was an employee of Nevro Corp. at the time the study was conducted and is now affiliated with Abbott, Sunnyvale, CA, USA. Dr Subbaroyan was an employee of Nevro Corp. at the time the study was conducted and received stock options from Nevro Corp. He is now affiliated with GTX Medical, New York, NY, USA. The authors report no other conflicts of interest in this work.

© 2020 Burgher et al.

Figures

Figure 1

Study design; (A) study flowchart; (B) lead placement; (C) 10 kHz Waveform; (D) 10 kHz SCS device and leads.

Figure 2

Sustained relief from UEP with 10 kHz SCS; (A) VAS pain scores (median Q1–Q3), (B–D) Tornado chart for upper limb, shoulder, and neck pain relief in individual subjects at 12 months, (E) Responder rates with responder defined as ≥50% pain relief, (F) Remitter rates at six months and 12-months with remitter defined as ≤3.0 cm VAS for six months.

Figure 3

Reduction in SF-MPQ scores with 10 kHz SCS; Data shown includes median (Q1–Q3) at indicated assessment times.

Figure 4

Improvement in quality of life and functioning with 10 kHz SCS; (A) PDI scores, (B) QuickDASH, (C) GAF, (D) SF-12 scores (PCS and MCS subscale respectively), Data shown includes median (Q1–Q3) at indicated assessment times.

Figure 5

Patient and physician global impression of change with 10 kHz SCS; (A–B) PGIC at three months and 12 months, (C–D) CGIC at three months and 12 months.

Figure 6

Improved sleep and subject satisfaction with 10 kHz SCS treatment; (A) PSQ-3 global scores at baseline and follow-up assessment (median: Q1–Q3), (B) Subject satisfaction at three and 12-month assessments.