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

January 16, 2023 updated by: Medical University of Lodz

Use of Low-frequency Magnetic Fields in the Hybrid Treatment of COVID-19 Patients: Preliminary Reports.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

39 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with COVID - 19, who we were treated with magnetic stimulation.

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.
Other: magnetostimulation
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.
Other Names:
  • low frequency magnetic field
  • magnetostimultaion
Other: 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.
Experimental: Patients with COVID - 19, who we were treated without magnetic stimulation.
The control group included patients receiving a comprehensive treatment without magnetic stimulation. The patients were in a moderately severe condition.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the level of proinflammatory factors (IL - 6)
Time Frame: 14 days
decrease in the level of proinflammatory factors (IL - 6)
14 days
the level of leukocytes (WBC)
Time Frame: 14 days
restoration of homeostasis in the body with regards to the range of WBC
14 days
the level of monocytes (MONO)
Time Frame: 14 days
restoration of homeostasis in the body with regards to the range of MONO
14 days
the level of platelets (PLT),
Time Frame: 14 days
restoration of homeostasis in the body with regards to the range of PLT
14 days
the level of CRP (c reactive protein)
Time Frame: 14 days
restoration of homeostasis in the body with regards to the range of CRP
14 days
the level of d-dimers.
Time Frame: 14 days
restoration of homeostasis in the body with regards to the range of d-dimers
14 days
arterial blood pressure,
Time Frame: 14 days
normalization of the arterial blood pressure,
14 days
the number of breaths/min
Time Frame: 14 days
normalization of the number of breaths/min
14 days
saturation
Time Frame: 14 days
normalization of saturation
14 days
temperature
Time Frame: 14 days
normalization of temperature
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Lodz

Investigators

  • Study Director: Marta Woldańska-Okońska, profesor, Department of Rehabilitation and Physical Medicine, Medical University of Lodz
  • Principal Investigator: Agnieszka Jankowska, doctor, Department of Rehabilitation and Physical Medicine, Medical University of Lodz
  • Principal Investigator: Robert Irzmański, profesor, Department of Internal Medicine and Cardiac Rehabilitation
  • Principal Investigator: Katarzyna Glibov, doctor, Department of Internal Medicine and Cardiac Rehabilitation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

December 17, 2021

First Submitted That Met QC Criteria

December 17, 2021

First Posted (Actual)

December 20, 2021

Study Record Updates

Last Update Posted (Actual)

January 19, 2023

Last Update Submitted That Met QC Criteria

January 16, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RNN/339/20/KE (Other Identifier: Bioethics Committee, Medical University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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