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Research ArticleLumbar Spine

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 and MARCO BRAYDA-BRUNO
International Journal of Spine Surgery December 2020, 14 (6) 936-943; DOI: https://doi.org/10.14444/7142
LEO MASSARI
1Department of Biomedical and Specialty Surgical Sciences, Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale Sant'Anna, University of Ferrara, Ferrara, Italy
MD
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GIOVANNI BARBANTI BRODANO
2Department of Oncological and Degenerative Spine Surgery, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy
MD
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STEFANIA SETTI
3IGEA SpA, Clinical Biophysics, Carpi, Italy
MSC
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GAETANO CARUSO
1Department of Biomedical and Specialty Surgical Sciences, Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale Sant'Anna, University of Ferrara, Ferrara, Italy
MD
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ENRICO GALLAZZI
4Spine Surgery III and Scoliosis Department, IRCCS Istituto Ortopedico Galeazzi, Milano, Italy
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SIMONA SALATI
3IGEA SpA, Clinical Biophysics, Carpi, Italy
PHD
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MARCO BRAYDA-BRUNO
4Spine Surgery III and Scoliosis Department, IRCCS Istituto Ortopedico Galeazzi, Milano, Italy
MD
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    Figure 1

    The OsteoSpine device (IGEA SpA). Correct positioning of the electrodes pad.

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    Figure 2

    Consolidated Standards of Reporting Trials (CONSORT) flow chart for patient enrolment.

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    Figure 3

    Quality of life measured by the Oswestry Disability Index (ODI). Graph showing mean ODI values, reported as mean ± SE. P value refers to a comparison between groups at each follow-up visit (†P < .05).

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    Figure 4

    Quality of life measured by the SF-36 Health Survey score. Graph showing mean variation compared with baseline values (A; P values are reported for differences between each follow-up versus baseline [*P < .05]) and mean SF-36 Health Survey values, reported as mean ± SE for patients who completed the clinical report form at each follow-up (B; P values refer to a comparison between groups at each follow-up visit [†P < .05]).

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    Figure 5

    Quality of life measured by ODI and VAS scores. Graph showing mean ODI values (A) and mean VAS values (B). Data are reported as mean ± SE; P values refer to a comparison between groups at each follow-up visit (†P < .05, §P < .01).

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International Journal of Spine Surgery
Vol. 14, Issue 6
1 Dec 2020
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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
International Journal of Spine Surgery Dec 2020, 14 (6) 936-943; DOI: 10.14444/7142

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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
International Journal of Spine Surgery Dec 2020, 14 (6) 936-943; DOI: 10.14444/7142
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  • Comparison of Stand-Alone Anterior Lumbar Interbody Fusion, 360° Anterior Lumbar Interbody Fusion, and Arthroplasty for Recurrent Lumbar Disc Herniation: Focus on Nerve Decompression and Painful Spinal Instability Resolution
  • Segmental Lordosis and Disc Height Discrepancies in Lateral Lumbar Interbody Fusion Using Expandable Cages
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Keywords

  • spinal fusion
  • capacitively coupled electric fields
  • quality of life
  • chronic back pain
  • randomized prospective placebo-controlled trial
  • level I

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