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

NCT ID: NCT05163613

Last Updated: 2023-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2025-01-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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COVID-19 COVID-19 Respiratory Infection COVID-19 Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

magnetostimulation

Intervention Type OTHER

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.

standard therapy

Intervention Type OTHER

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.

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.

Group Type EXPERIMENTAL

standard therapy

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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low frequency magnetic field magnetostimultaion

Eligibility Criteria

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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
Minimum Eligible Age

39 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Lodz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marta Woldańska-Okońska, profesor

Role: STUDY_DIRECTOR

Department of Rehabilitation and Physical Medicine, Medical University of Lodz

Agnieszka Jankowska, doctor

Role: PRINCIPAL_INVESTIGATOR

Department of Rehabilitation and Physical Medicine, Medical University of Lodz

Robert Irzmański, profesor

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine and Cardiac Rehabilitation

Katarzyna Glibov, doctor

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine and Cardiac Rehabilitation

Locations

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Department of Rehabilitation and Physical Medicine, Medical University of Lodz

Lodz, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Agnieszka Jankowska, doctor

Role: CONTACT

532519534 ext. +48

Marta Woldańska-Okońska, profesor

Role: CONTACT

601377610 ext. +48

Facility Contacts

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Agnieszka Jankowska, Doctor

Role: primary

532519534 ext. +48

Marta Woldańska-Okońska, Profesor

Role: backup

601377610 ext. +48

Other Identifiers

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RNN/339/20/KE

Identifier Type: OTHER

Identifier Source: secondary_id

RNN/339/20/KE

Identifier Type: -

Identifier Source: org_study_id

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