• Int J Spine Surg · Dec 2020

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

    • Leo Massari, BrodanoGiovanni BarbantiGBDepartment of Oncological and Degenerative Spine Surgery, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy., Stefania Setti, Gaetano Caruso, Enrico Gallazzi, Simona Salati, and Marco Brayda-Bruno.
    • Department of Biomedical and Specialty Surgical Sciences, Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale Sant'Anna, University of Ferrara, Ferrara, Italy.
    • Int J Spine Surg. 2020 Dec 1; 14 (6): 936-943.

    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 EvidenceI.Clinical RelevanceThis 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.This manuscript is generously published free of charge by ISASS, the International Society for the Advancement of Spine Surgery. Copyright © 2020 ISASS.

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