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

Abstract

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: 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: This study demonstrates a significant improvement in CCEF-treated patients at 6 and 12 months' followup 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: 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: 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.

Capacitive interdigitated system of high osteoinductive/conductive performance for personalized acting-sensing implants

“…Contrary to DC and IC, CC stimulation induces less reactive oxygen species or oxidative stress 44 , while promoting osteogenic effects in vitro 45 – 49 , either using low frequencies (LFs) 45 , 46 or high frequencies (HFs) 47 – 49 . CC stimulation with HF (60 kHz) can also aid in bone fracture healing in vivo 50 – 53 . However, currently in orthopedics, CC uses extracorporeal electrodes placed parallelly on opposite sides of the bone.…”

Capacitive biophysical stimulation improves the healing of vertebral fragility fractures: a prospective multicentre randomized controlled trial

“…The main limitation of the present study is the lack of a placebo device in the control group. However, the effectiveness of capacitive biophysical stimulation over a placebo device has already been documented by Rossini et al [ 11 ] and Massari et al [ 12 ]; consequently, the use of a placebo device was considered unnecessary in this study. Furthermore, all the study data were gathered and analysed blindly.…”

“…CCEF stimulation is currently used in the treatment of recalcitrant non-union healing [ 21 , 22 ], as an adjunct in the treatment of vertebral fusions [ 12 , 13 ], in the treatment of acute VFFs [ 5 ] and in patients with chronic VFFs to reduce NSAID consumption for chronic pain [ 11 ].…”

“…CCEF is a non-invasive type of biophysical stimulation used to enhance fracture repair and spinal fusion [ 5 , 11 ]. In cases of osteoporotic vertebral fracture, positive effects of CCEF on chronic pain [ 1 ], postoperative pain, disability and quality of life after spinal fusion have been reported [ 12 ].…”

Pulsed Electromagnetic Field Affects the Development of Postmenopausal Osteoporotic Women with Vertebral Fractures

“…Electrostimulation therapy includes direct current, capacitive coupling, and inductive coupling to promote the spine fusion [34]. Electrical stimulation signals also increase the expression of bone-related genes such as transforming growth factor-β superfamily genes (TGF-β1, TGF-β2, TGF-β3, bone morphogenetic protein-2, and morphogenetic protein-4), fibroblast growth factor-(FGF-) 2, osteocalcin (BGP), and alkaline phosphatase (ALP), to promote fracture healing [35], and the effects of this treatment can last up to 12 months [36]. Pulsed electromagnetic field therapy can relieve pain in patients, mainly in a nontoxic and low-risk way to promote the healing and recovery of cell activity [37].…”