Evidence map›Paper›PMID 29220121›Full record

Trial reportNeuromodulation : journal of the International Neuromodulation Society2018

Effects of Rate on Analgesia in Kilohertz Frequency Spinal Cord Stimulation: Results of the PROCO Randomized Controlled Trial.

Simon J Thomson, Moein Tavakkolizadeh, Sarah Love-Jones, Nikunj K Patel, Jianwen Wendy Gu, Amarpreet Bains, Que Doan, Michael Moffitt

2 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Neuromodulation : journal of the International Neuromodulation Society, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 62 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
62citing papers in PubMed, 5 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.

NCT02549183 nacompletednot on this map

Evaluation of Stimulation Pulse Rate on Clinical Outcomes in Patients Whose Pain is Controlled by 10KHz Frequency - a Feasibility Study

TypeinterventionalSponsorMid and South Essex NHS Foundation TrustRan2015 to 2017Enrolled22ConditionsBack Pain, NeuralgiaArmsBoston Scientific PRECISION Spinal Cord Stimulator System
NCT06585033 narecruitingnot on this mapstarted 2024, after this paper: background citation

Spinal Cord Stimulation for the Treatment of Therapy-Resistant Neuropathic Pain After Lumbar Spinal Surgery - A Randomized, Double-Blind, Sham-Controlled, Cross-over Study

TypeinterventionalSponsorSahlgrenska University HospitalRan2024 to 2027Enrolled50ConditionsChronic Postoperative PainArmsSpinal cord stimulation
3 · Its place in the literature

Who cites it

62 citing papers in PubMed, 5 syntheses or guidelines pooled it.

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  19. Spinal Cord Stimulation for Painful Diabetic Neuropathy.Journal of diabetes science and technology · 2024
    Review
  20. Article

2 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Simon J ThomsonDepartment of Anesthesiology, Basildon and Thurrock University Hospitals NHS Foundation Trust, Basildon, Essex, UK.
Moein TavakkolizadehDepartment of Anesthesiology, University College London Hospitals NHS Foundation Trust, Bloomsbury, London, UK.
Sarah Love-JonesDepartment of Anesthesiology, Trust Headquarters Southmead Hospital, North Bristol NHS Trust, Bristol, UK.
Nikunj K PatelNeurosurgery, Trust Headquarters Southmead Hospital, North Bristol NHS Trust, Bristol, UK.
Jianwen Wendy GuResearch and Development, Boston Scientific Neuromodulation, Valencia, CA, USA.
Amarpreet BainsClinical, Boston Scientific Neuromodulation, Valencia, CA, USA.
Que DoanResearch and Development, Boston Scientific Neuromodulation, Valencia, CA, USA.
Michael MoffittResearch and Development, Boston Scientific Neuromodulation, Valencia, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe PROCO RCT is a multicenter, double-blind, crossover, randomized controlled trial (RCT) that investigated the effects of rate on analgesia in kilohertz frequency (1-10 kHz) spinal cord stimulation (SCS). MATERIALS AND

methodsPatients were implanted with SCS systems and underwent an eight-week search to identify the best location ("sweet spot") of stimulation at 10 kHz within the searched region (T8-T11). An electronic diary (e-diary) prompted patients for pain scores three times per day. Patients who responded to 10 kHz per e-diary numeric rating scale (ED-NRS) pain scores proceeded to double-blind rate randomization. Patients received 1, 4, 7, and 10 kHz SCS at the same sweet spot found for 10 kHz in randomized order (four weeks at each frequency). For each frequency, pulse width and amplitude were titrated to optimize therapy.

resultsAll frequencies provided equivalent pain relief as measured by ED-NRS (p ≤ 0.002). However, mean charge per second differed across frequencies, with 1 kHz SCS requiring 60-70% less charge than higher frequencies (p ≤ 0.0002).

conclusionsThe PROCO RCT provides Level I evidence for equivalent pain relief from 1 to 10 kHz with appropriate titration of pulse width and amplitude. 1 kHz required significantly less charge than higher frequencies.

Indexed as

Treatment OutcomeAdultAgedAnalgesiaChronic PainCross-Over StudiesDouble-Blind MethodFemaleFollow-Up StudiesHumansMaleMiddle AgedPain MeasurementPain ThresholdQuality of LifeSpinal Cord StimulationChronic paindouble-blindhigh frequencyhigh frequency SCSkilohertz SCSPROCOrandomized controlled trialsub-perception SCS

Identifiers

PMID29220121
PMCPMC5814855

What OpenQuestion holds

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Registered trials

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.