Noninvasive electrical stimulation as an adjunct to fusion procedures: a systematic review and meta-analysis

Abstract

OBJECTIVE Noninvasive electrical stimulation represents a distinct group of devices used to augment fusion rates. However, data regarding outcomes of noninvasive electrical stimulation have come from a small number of studies. The goal of this systematic review and meta-analysis was to determine outcomes of noninvasive electrical stimulation used as an adjunct to fusion procedures to improve rates of successful fusion. METHODS PubMed, Embase, and the Cochrane Clinical Trials database were searched according to search strategy and PRISMA guidelines. Random-effects meta-analyses of fusion rates with the three main modalities of noninvasive electrical stimulation, capacitively coupled stimulation (CCS), pulsed electromagnetic fields (PEMFs), and combined magnetic fields (CMFs), were conducted using R version 4.1.0 (The R Foundation for Statistical Computing). Both retrospective studies and clinical trials were included. Animal studies were excluded. Risk-of-bias analysis was performed with the Risk of Bias 2 (RoB 2) and Risk of Bias in Nonrandomized Studies of Interventions (ROBINS-I) tools. RESULTS Searches of PubMed, Embase, and the Cochrane Clinical Trials database identified 8 articles with 1216 participants meeting criteria from 213 initial results. There was a high overall risk of bias identified for the majority of randomized studies. No meta-analysis could be performed for CCS as only 1 study was identified. Meta-analysis of 6 studies of fusion rates in PEMF did not find any difference between treatment and control groups (OR 1.89, 95% CI 0.36–9.80, p = 0.449). Meta-analysis of 2 studies of CMF found no difference in fusion rates between control and treatment groups (OR 0.90, 95% CI 0.07–11.93, p = 0.939). Subgroup analysis of PEMF was limited given the small number of studies and patients, although significantly increased fusion rates were seen in some subgroups. CONCLUSIONS This meta-analysis of clinical outcomes and fusion rates in noninvasive electrical stimulation compared to no stimulation did not identify any increases in fusion rates for any modality. A high degree of heterogeneity between studies was noted. Although subgroup analysis identified significant differences in fusion rates in certain groups, these findings were based on a small number of studies and further research is needed. This analysis does not support routine use of these devices to augment fusion rates, although the data are limited by a high risk of bias and a small number of available studies.