Evidence map›Paper›PMID 33560253›Full record

ArticleInternational journal of spine surgery2020

Does Capacitively Coupled Electric Fields Stimulation Improve Clinical Outcomes After Instrumented Spinal Fusion? A Multicentered Randomized, Prospective, Double-Blind, Placebo-Controlled Trial.

Leo Massari, Giovanni Barbanti Brodano, Stefania Setti, Gaetano Caruso, Enrico Gallazzi, Simona Salati, Marco Brayda-Bruno

Open access · diamondAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in International journal of spine surgery, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 27% 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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Capacitive biophysical stimulation improves the healing of vertebral fragility fractures: a prospective multicentre randomized controlled trial.Journal of orthopaedics and traumatology : official journal of the Italian Society of Orthopaedics and Traumatology · 2024
    Trial
  3. Trial
  4. Review
  5. 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

7 authors at 5 institutions in 1 country.

Leo MassariDepartment of Biomedical and Specialty Surgical Sciences, Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale Sant'Anna, University of Ferrara, Ferrara, Italy.
Giovanni Barbanti BrodanoDepartment of Oncological and Degenerative Spine Surgery, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.
Stefania SettiIGEA SpA, Clinical Biophysics, Carpi, Italy.
Gaetano CarusoDepartment of Biomedical and Specialty Surgical Sciences, Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale Sant'Anna, University of Ferrara, Ferrara, Italy.
Enrico GallazziSpine Surgery III and Scoliosis Department, IRCCS Istituto Ortopedico Galeazzi, Milano, Italy.
Simona SalatiIGEA SpA, Clinical Biophysics, Carpi, Italy.
Marco Brayda-BrunoSpine Surgery III and Scoliosis Department, IRCCS Istituto Ortopedico Galeazzi, Milano, Italy.
IGEA Clinical Biophysics (Italy) · ITIstituto Ortopedico Galeazzi · ITArcispedale Sant'Anna · ITIstituto Ortopedico Rizzoli · ITUniversity of Ferrara · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLumbar spinal fusion (LSF) is used to treat lumbar degenerative disorders. Methods to improve the functional recovery of patients undergoing LSF is one of the main goals in daily clinical practice. The objective of this study is to assess whether biophysical stimulation with capacitively coupled electric fields (CCEF) can be used as adjuvant therapy to enhance clinical outcome in LSF-treated patients.

methodsForty-two patients undergoing LSF were assessed and randomly allocated to either the active or to the placebo group. Follow-up visits were performed at 1, 3, 6, and 12 months after surgery; long-term follow-up was performed at year 10. Visual analogue scale (VAS), the Oswestry Disability Index (ODI), and the 36-item Short Form Health Survey (SF-36) questionnaire were recorded.

resultsThis study demonstrates a significant improvement in CCEF-treated patients at 6 and 12 months' follow-up for SF-36, and at 12 months' follow-up for ODI values. Based on SF-36 and ODI scores, we reported a significantly higher percentage of successful treatments at 12 months in the active compared with the placebo group. Moreover, in a subset of patients at 10 years' follow-up, a significant difference was reported in VAS and ODI scores between groups.

conclusionsThe results demonstrate that 3 months of CCEF treatment immediately after surgery is effective in reducing ODI and improving SF-36 score, and that these benefits can be maintained up to 12 months. In a subset of patients, these positive outcomes are retained up to 10 years. LEVEL OF EVIDENCE: I. CLINICAL RELEVANCE: This study suggests that CCEF stimulation can be used as an adjunct to LSF for spine diseases, for increasing overall quality of life and improving patients' functional recovery. CCEF is safe and well tolerated, compatible with activities of daily living.

Indexed as

capacitively coupled electric fieldschronic back painlevel Iquality of liferandomized prospective placebo-controlled trialspinal fusion

Identifiers

PMID33560253
PMCPMC7872405
OpenAlexW3125576259

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.