Evidence map›Paper›PMID 33463027›Full record

ArticlePain practice : the official journal of World Institute of Pain2021

High-Frequency Spinal Cord Stimulation at 10 kHz for the Treatment of Nonsurgical Refractory Back Pain: Design of a Pragmatic, Multicenter, Randomized Controlled Trial.

Naresh Patel, Aaron Calodney, Leonardo Kapural, Rose Province-Azalde, Shivanand P Lad, Julie Pilitsis, Chengyuan Wu, Taissa Cherry, Jeyakumar Subbaroyan, Bradford Gliner and 1 more

Open access · hybridAbstract readClinical Trial Protocol
In one paragraph

Article 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 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
2.3field-weighted citation impact, top 12% 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

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 18 citations in OpenAlex.

  1. The Implementation of Persistent Spinal Pain Syndrome (PSPS): Mechanism-Based Recommendations.Pain practice : the official journal of World Institute of Pain · 2026
    Guideline
  2. Implanted spinal neuromodulation interventions for chronic pain in adults.The Cochrane database of systematic reviews · 2021
    Pooled it
  3. Review
  4. Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. Spinal cord stimulation for low back pain.The Cochrane database of systematic reviews · 2023
    Review
  10. Article
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

11 authors at 8 institutions in 1 country.

Naresh PatelMayo Clinic, Phoenix, Arizona, U.S.A.
Aaron CalodneyPrecision Spine Care, Tyler, Texas, U.S.A.
Leonardo KapuralCarolina's Pain Institute, Winston-Salem, North Carolina, U.S.A.ORCID 0000-0003-2718-5837
Rose Province-AzaldeNevro Corp, Redwood City, California, U.S.A.
Shivanand P LadDuke University Medical Center, Durham, North Carolina, U.S.A.
Julie PilitsisAlbany Medical College, Albany, New York, U.S.A..
Chengyuan WuThomas Jefferson University, Philadelphia, Pennsylvania, U.S.A.
Taissa CherryKaiser Permanente, Redwood City, California, U.S.A.
Jeyakumar SubbaroyanNevro Corp, Redwood City, California, U.S.A.
Bradford GlinerNevro Corp, Redwood City, California, U.S.A.
David CarawayNevro Corp, Redwood City, California, U.S.A.
Nevro (United States) · USAlbany Medical Center Hospital · USCarolinas Pain Institute · USDuke University · USKaiser Permanente Redwood City Medical Center · USMayo Clinic in Arizona · USPrecision Spine (United States) · USThomas Jefferson University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSpinal cord stimulation (SCS) has been shown to provide pain relief for chronic back and leg pain due to failed back surgery syndrome. But many patients with chronic back pain have not had major back surgery or are not good candidates for surgery, and conventional medical management (CMM) provides limited relief. We have termed this condition nonsurgical refractory back pain (NSRBP). Level 1 evidence does not yet exist showing the therapeutic benefit of SCS for NSRBP.

objectiveTo compare 10-kHz SCS plus CMM (10-kHz SCS + CMM) to CMM alone for treatment of NSRBP in terms of clinical and cost effectiveness. STUDY

designMulticenter, randomized controlled trial (RCT), with subjects randomized 1:1 to either 10-kHz SCS + CMM or CMM alone. Optional crossover occurs at 6 months if treatment does not achieve ≥50% pain relief.

methodsPatients with NSRBP as defined above may be enrolled if they are ineligible for surgery based on surgical consultation. Subjects randomized to 10-kHz SCS + CMM will receive a permanent implant if sufficient pain relief is achieved in a temporary trial. Both groups will receive CMM per standard of care and will undergo assessments at baseline and at follow-ups to 12 months. Self-report outcomes include pain, disability, sleep, mental health, satisfaction, healthcare utilization, and quality of life.

resultsEnrollment was initiated on September 10, 2018. Prespecified independent interim analysis at 40% of the enrollment target indicated the sample size was sufficient to show superiority of treatment at the primary endpoint; therefore, enrollment was stopped at 211.

conclusionsThis large multicenter RCT will provide valuable evidence to guide clinical decisions in NSRBP.

Indexed as

Back PainPain ManagementSpinal Cord StimulationChronic PainCost-Benefit AnalysisCross-Over StudiesHumansMulticenter Studies as TopicPragmatic Clinical Trials as TopicQuality of LifeTreatment Outcome10-kHz SCShigh-frequencymedical managementnonsurgical refractory back painspinal cord stimulation

Identifiers

PMID33463027
PMCPMC7891432
OpenAlexW3049739942

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.