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

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

Journal

International journal of spine surgery
ISSN: 2211-4599
Titre abrégé: Int J Spine Surg
Pays: Netherlands
ID NLM: 101579005

Informations de publication

Date de publication:
Dec 2020
Historique:
entrez: 9 2 2021
pubmed: 10 2 2021
medline: 10 2 2021
Statut: ppublish

Résumé

Lumbar 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. Forty-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. This 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. The 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. I. 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.

Sections du résumé

BACKGROUND BACKGROUND
Lumbar 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.
METHODS METHODS
Forty-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.
RESULTS RESULTS
This 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.
CONCLUSIONS CONCLUSIONS
The 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 METHODS
I.
CLINICAL RELEVANCE CONCLUSIONS
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.

Identifiants

DOI: 10.14444/7142 PMID: 33560253 PMC: PMC7872405
pubmed: 33560253
pii: 7142
doi: 10.14444/7142
pmc: PMC7872405
doi:

Types de publication

Journal Article

Langues

eng

Pagination

936-943

Informations de copyright

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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Auteurs

Leo Massari (L)

Department of Biomedical and Specialty Surgical Sciences, Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale Sant'Anna, University of Ferrara, Ferrara, Italy.

Giovanni Barbanti Brodano (GB)

Department of Oncological and Degenerative Spine Surgery, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.

Stefania Setti (S)

IGEA SpA, Clinical Biophysics, Carpi, Italy.

Gaetano Caruso (G)

Department of Biomedical and Specialty Surgical Sciences, Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale Sant'Anna, University of Ferrara, Ferrara, Italy.

Enrico Gallazzi (E)

Spine Surgery III and Scoliosis Department, IRCCS Istituto Ortopedico Galeazzi, Milano, Italy.

Simona Salati (S)

IGEA SpA, Clinical Biophysics, Carpi, Italy.

Marco Brayda-Bruno (M)

Spine Surgery III and Scoliosis Department, IRCCS Istituto Ortopedico Galeazzi, Milano, Italy.

Classifications MeSH