Evidence map›Paper›PMID 31792530›Full record

Trial reportNeurosurgery2020

High-Frequency Spinal Cord Stimulation at 10 kHz for the Treatment of Combined Neck and Arm Pain: Results From a Prospective Multicenter Study.

Kasra Amirdelfan, Ricardo Vallejo, Ramsin Benyamin, Cong Yu, Thomas Yang, Richard Bundschu, Thomas L Yearwood, B Todd Sitzman, Bradford Gliner, Jeyakumar Subbaroyan and 2 more

Abstract readClinical TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neurosurgery, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 1 synthesis or guideline pooled it.

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  6. Pain, quality of life, and function in chronic intractable leg pain were substantially improved with 10kHz spinal cord stimulation in a multicentre European study.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2025
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  9. Motor improvement and spasms recovery with high-frequency 10 kHz spinal cord stimulation in a patient with spastic tetraparesis: beyond pain relief.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2024
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors.

Kasra AmirdelfanIPM Medical Group Inc., Walnut Creek, California.
Ricardo VallejoMillennium Pain Center, Bloomington, Illinois.
Ramsin BenyaminMillennium Pain Center, Bloomington, Illinois.
Cong YuSwedish Pain Center, Seattle, Washington.
Thomas YangSwedish Pain Center, Seattle, Washington.
Richard BundschuCoastal Orthopedics and Pain Medicine, Bradenton, Florida.
Thomas L YearwoodComprehensive Pain and Rehabilitation, Pascagoula, Mississippi.
B Todd SitzmanAdvanced Pain Therapy, PLLC, Hattiesburg, Mississippi.
Bradford GlinerNevro Corp, Redwood City, California.
Jeyakumar SubbaroyanNevro Corp, Redwood City, California.
Anand RotteNevro Corp, Redwood City, California.
David CarawayNevro Corp, Redwood City, California.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIntractable neck and upper limb pain has historically been challenging to treat with conventional spinal cord stimulation (SCS) being limited by obtaining effective paresthesia coverage.

objectiveTo assess the safety and effectiveness of the 10-kHz SCS system, a paresthesia-independent therapy, in the treatment of neck and upper limb pain.

methodsSubjects with chronic, intractable neck and/or upper limb pain of ≥5 cm (on a 0-10 cm visual analog scale [VAS]) were enrolled in 6 US centers following an investigational device exemption from the Food and Drug Administration (FDA) and institutional review board approval. Each subject was implanted with 2 epidural leads spanning C2-C6 vertebral bodies. Subjects with successful trial stimulation were implanted with a Senza® system (Nevro Corp) and included in the evaluation of the primary safety and effectiveness endpoints.

resultsIn the per protocol population, the primary endpoint (≥50% pain relief at 3 mo) was achieved in 86.7% (n = 39/45) subjects. Compared to baseline, subjects reported a significant reduction (P < .001) in their mean (± standard error of the mean) VAS scores at 12-mo assessment for neck pain (7.6 ± 0.2 cm, n = 42 vs 1.5 ± 0.3 cm, n = 37) and upper limb pain (7.1 ± 0.3 cm, n = 24 vs 1.0 ± 0.2 cm, n = 20). At 12-mo assessment, 89.2% of subjects with neck pain and 95.0% with upper limb pain had ≥50% pain relief from baseline, 95.0% reported to be "satisfied/very satisfied" and 30.0% either eliminated or reduced their opioid intake.

conclusionIn conclusion, 10-kHz SCS can treat intractable neck and upper limb pain with stable long-term outcomes.

Indexed as

AdultAgedArmCervical VertebraeChronic PainFemaleHumansMaleMiddle AgedNeck PainNeuralgiaPain ManagementProspective StudiesSpinal Cord StimulationSpinal DiseasesTreatment Outcome10-kHz SCSNeck pain and opioidsUpper limb painVAS

Identifiers

PMID31792530
PMCPMC7360873

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.