Evidence map›Paper›PMID 40192770›Full record

Observational studyEuropean spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society2025

Pain, quality of life, and function in chronic intractable leg pain were substantially improved with 10kHz spinal cord stimulation in a multicentre European study.

Iris Smet, Bart Billet, Pieter Jan Germonpré, Isaac Peña, Agustín Mendiola de la Osa, Doerthe Keiner, Enrico Polati, Peter Lindblom, Veerle Minne, Shibasis Chowdhury and 6 more

Erratum issuedAbstract readMulticenter StudyObservational Study
PubMed Publisher
In one paragraph

Observational study in 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. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors.

Iris SmetAZ Nikolaas, Sint-Niklaas, Belgium.
Bart BilletAZ Delta, Roeselare, Belgium.
Pieter Jan GermonpréAZ Groeninge, Kortrijk, Belgium.
Isaac PeñaHospital Universitario Virgen Del Rocio, Seville, Spain.
Agustín Mendiola de la OsaHospital Universitario Puerta Del Hierro, Majadahonda, Spain.
Doerthe KeinerUniversitätsklinikum des Saarlandes Klinik für Neurochirurgie, Homburg, Germany.
Enrico PolatiAzienda Ospedaliera Universitaria Integrata Verona, Verona, Italy.
Peter LindblomSmärtcentrum, Gävle Sjukhus, Gävle, Sweden.
Veerle MinneNevro Corp, Redwood City, USA.
Shibasis ChowdhuryNevro Corp, Redwood City, USA.
Sarah E BanducciNevro Corp, Redwood City, USA.
Sameer DhamneNevro Corp, Redwood City, USA.
Rokas TamosauskasCambridge University, Cambridge, UK.
Nicholas ParkRoyal Preston Hospital, Preston, UK.
Abdul LalkhenSalford Royal NHS Foundation Trust, Salford, UK.
Girish VajramaniUniversity Hospital Southampton NHS Foundation Trust, Southampton, UK. girish.vajramani@uhs.nhs.uk.

Funding

Nevro Nevro
6 · The paper itself

Abstract

purposeThis prospective, single-arm, multicentre study evaluated the effectiveness of 10 kHz spinal cord stimulation (SCS) in relieving pain and improving function and quality of life in patients with chronic intractable leg pain in routine clinical practice.

methodsPatients with leg pain refractory to conservative therapy and scoring ≥ 5 cm on a 10-cm visual analog scale (VAS) were enrolled at 12 centres. Those who achieved ≥ 50% leg pain relief during a temporary trial underwent permanent implantation and were followed for 12 months. Outcomes collected included the proportion of patients who achieved ≥ 50% reduction in leg pain VAS score, health-related quality-of-life (EQ-5D-5 L, functional disability [ODI]), opioid use, sleep quality (PSQ-3), global impression of change (GIC), and patient satisfaction.

resultsOf 121 patients trialed, 118 completed the trial and 95 proceeded to implant. At 3 months, 61/95 (64.2%) of all implanted patients were responders to therapy (≥ 50% VAS reduction), which remained stable at 64.2% through 12 months. EQ-5D-5 L, ODI, and PSQ-3 showed clinically important and sustained improvement over 12 months (repeated measures ANOVA, p < 0.001). Patients also reduced opioid dosage on average (p = 0.022). The safety profile was consistent with previous reports using 10 kHz SCS.

conclusionThis study supports 10 kHz SCS as an effective and safe therapeutic option to reduce pain and disability while improving health-related quality of life in patients with chronic intractable leg pain. 10 kHz SCS appears to be effective in significantly improving the severe disability and poor quality of life experienced by patients with chronic intractable leg pain. STUDY REGISTERED: ISRCTN Registry - ISRCTN11180496.

Indexed as

Chronic PainIntractable PainLegPain ManagementQuality of LifeSpinal Cord StimulationAdultAgedEuropeFemaleHumansMaleMiddle AgedPain MeasurementProspective StudiesTreatment OutcomeChronic leg painHigh frequency SCSLeg painSCSSpinal cord stimulation

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.