Evidence map›Paper›PMID 33274545›Full record

Trial reportPain practice : the official journal of World Institute of Pain2021

10 kHz Spinal Cord Stimulation for the Treatment of Failed Back Surgery Syndrome with Predominant Leg Pain: Results from a Prospective Study in Patients from the Dutch Healthcare System.

Jan Willem Kallewaard, Ismail Gültuna, Vincent Hoffmann, Lars Elzinga, Renate Munnikes, Lisette Verbrugge, Veerle Minne, Pascalle Reiters, Jeyakumar Subbaroyan, Angela Santos and 2 more

Open access · hybridAbstract readClinical Trial
In one paragraph

Trial report in Pain practice : the official journal of World Institute of Pain, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
1.8field-weighted citation impact, top 15% of its field
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

9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. 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
    Observational
  6. Review
  7. Review
  8. Article
  9. Review
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

12 authors at 6 institutions in 2 countries.

Jan Willem KallewaardRijnstate Ziekenhuis Velp, Pijncentrum, Pijnbehandelcentrum, Velp, The Netherlands.ORCID 0000-0002-7681-1796
Ismail GültunaAlbert Schweitzer Ziekenhuis, Pijnbehandelcentrum, Zwijndrecht, The Netherlands.
Vincent HoffmannAmphia Ziekenhuis Breda, Pijnbehandelcentrum, Breda, The Netherlands.
Lars ElzingaBravis Ziekenhuis Roosendaal, Pijncentrum, Roosendaal, The Netherlands.
Renate MunnikesMaasstad Ziekenhuis Rotterdam, Pijnkliniek, Rotterdam, The Netherlands.
Lisette VerbruggeMaasstad Ziekenhuis Rotterdam, Pijnkliniek, Rotterdam, The Netherlands.
Veerle MinneNevro Corp., Redwood City, California, U.S.A.
Pascalle ReitersNevro Corp., Redwood City, California, U.S.A.
Jeyakumar SubbaroyanNevro Corp., Redwood City, California, U.S.A.
Angela SantosNevro Corp., Redwood City, California, U.S.A.
Anand RotteNevro Corp., Redwood City, California, U.S.A.ORCID 0000-0002-3452-7068
David CarawayNevro Corp., Redwood City, California, U.S.A.
Nevro (United States) · USMaasstad Ziekenhuis · NLAlbert Schweitzer Ziekenhuis · NLAmphia Ziekenhuis · NLBravis Ziekenhuis · NLRijnstate Hospital · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPersistent back/and or leg pain is a common outcome after spinal surgery (otherwise known as failed back surgery syndrome [FBSS]). Studies have shown that spinal cord stimulation (SCS) at 10 kHz provides effective analgesia in FBSS patients with both back and leg pain symptoms and in those with predominant back pain. This study is the first to evaluate the therapy in FBSS patients with predominant leg pain.

methodsThe safety and efficacy of 10 kHz SCS was evaluated in an uncontrolled, open-label, prospective study of FBSS patients with predominant leg pain in the Netherlands. Follow-ups were performed at 1, 3, 6, and 12 months post implantation.

resultsSixty out of 68 patients (88%) experienced sufficient pain relief during a stimulation trial. Of these, 58 proceeded to permanent implantation of a 10 kHz SCS system. After 12 months of treatment, 80% of patients experienced ≥ 50% reduction in baseline leg pain, and a similar proportion (76%) experienced ≥ 50% reduction in baseline back pain. At least two-thirds of patients were also leg pain and back pain remitters (visual analog scale [VAS] ≤ 2.5 cm). The therapy was also associated with a general improvement in patients' quality of life, as measured by secondary outcomes including disability, perception of health improvement, mental well-being, and satisfaction. A positive impact on opioid consumption was also observed.

conclusionsConsistent with previous findings, 10 kHz SCS for the treatment of FBSS patients with predominant radicular symptoms is safe and effective and is associated with improved quality of life.

Indexed as

Failed Back Surgery SyndromeSpinal Cord StimulationDelivery of Health CareHumansLegProspective StudiesQuality of LifeSpinal CordTreatment Outcome10 kHz SCSfailed back surgery syndromeleg pain and VAS

Identifiers

PMID33274545
PMCPMC8247309
OpenAlexW3107975261

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.