Use of Low-frequency Magnetic Fields in the Hybrid Treatment of COVID-19 Patients

Medical University of Lodz

Status: Enrolling

Conditions: COVID-19; COVID-19 Pneumonia; COVID-19 Respiratory Infection

Treatments: Other: magnetostimulation; Other: standard therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05163613

RNN/339/20/KE (Other Identifier)

Details and patient eligibility

About

The purpose of this study was to evaluate the efficacy of low-frequency magnetic field in the hybrid treatment of COVID-19 patients, i.e., including magnetostimulation in the standard treatment. The authors evaluated among other things, the immunocorrective therapeutic effect of magnetostimulation, improving the defensive functions of the immune system and thus supporting the immune function by, among other things, suppressing the "cytokine storm".

After application of low-frequency magnetic field in the hybrid treatment of COVID-19 patients, the authors expected: a decrease in the level of proinflammatory factors (IL - 6), restoration of homeostasis in the body with regards to the range of parameters evaluated in laboratory tests (WBC, MONO, PLT, CRP, d-dimers) and normalization of the following parameters: arterial blood pressure, the number of breaths/min, saturation, temperature.

Full description

Study aim:

The purpose of this study was to evaluate the efficacy of low-frequency magnetic field in the hybrid treatment of COVID-19 patients, i.e., including magnetostimulation in the standard treatment.

Material and methods:

The study was conducted on patients aged 39 to 80 years, of both sexes affected by COVID-19. The study subjects were recruited at the Covid Unit of the Military Medical Academy University Teaching Hospital - Central Veterans' Hospital in Lodz. The study group (13 patients) included patients hospitalized due to PCR (polymerase chain reaction)-confirmed SARS (severe acute respiratory syndrome) -Cov-2 infection, who were treated with magnetostimulation in addition to a standard therapy. The control group (10 patients) included patients receiving a comprehensive treatment without magnetostimulation. The patients hospitalized due to PCR-confirmed SARS - Cov - 2 infection were qualified for the study. Patients with absolute contraindications to magnetic field application and patients with limited verbal - logical contact were excluded from the study.

In the study groups, the patients were subjected to magnetic field - magnetostimulation with the use of apparatus Viofor JPS System (mata). 14 treatments were performed, 7 times a week. Treatment parameters: 12 minutes M2P2 program, with increasing intensity from 1 to 8. The authors applied magnetic field with a frequency of 180 - 190 Hz, pulse packet frequencies between 12.5 and 29 Hz, packet groups 2.8 - 7.6 Hz, series 0.08 - 0.3 Hz, with magnetic induction B= 3.2 µT (on average) and B = 40 µT at a pulse peak.

In laboratory tests, the following levels were assessed in the patients: interleukin 6 (IL -6), leukocytes (WBC), monocytes (MONO), platelets (PLT), CRP and d-dimers. The patients' blood was taken twice: on admission to the department and after a series of treatments with magnetostimulation. Approximately 6 ml of blood was collected at one time (3 tubes).

Medical records of the patients and scientific reports collected from the University Library and medical databases, e.g. PubMed, were analyzed and discussed.

Enrollment: 120 estimated patients

Sex: All

Ages: 39 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients hospitalized due to PCR-confirmed SARS - Cov - 2 infection

Exclusion criteria

• patients with absolute contraindications to magnetic field application
• patients with limited verbal - logical contact were excluded from the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Patients with COVID - 19, who we were treated with magnetic stimulation.

Experimental group

Description:

The study group included patients hospitalized due to PCR-confirmed SARS-Cov-2 infection, who were treated with magnetic stimulation in addition to a standard therapy. Standard therapy used in all patients consisted of the use of pharmacological agents necessary to treat the viral infection (antiviral drugs, antibiotics, dexamethasone) and the inclusion of proper care, education, occupational therapy, self-service learning, breathing exercises and motor mobilization.

Treatment:

Other: magnetostimulation

Other: standard therapy

Patients with COVID - 19, who we were treated without magnetic stimulation.

Experimental group

Description:

The control group included patients receiving a comprehensive treatment without magnetic stimulation. The patients were in a moderately severe condition.

Treatment:

Other: standard therapy