Treatment of Rheumatoid Hand With Magnetotherapy

July 6, 2023 updated by: Jolanta Zwolińska

Type of Magnetic Field and the Effects of Rheumatoid Arthritis Treatment

Brief Summary:

Participants with rheumatoid arthritis with recommendation to physiotherapy.

Created 2 study groups:

  1. Kinesiotherapy with static magnetic field
  2. Kinesiotherapy with low-frequency pulsed magnetic field

Pulsed magnetic field give better effects then static magnetic field.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Participants with rheumatoid arthritis with recommendation to physiotherapy. All participants have dysfunction and pain of hand. Before entering the study, all patients were examined by a rheumatologist, who determined the degree of radiological and functional changes and measured blood pressure. Patients with II° and III° of radiological and functional changes were qualified for the study. All the patients gave their informed consent to participate in the study. The examination included an overall assessment of functional status. Patients were examined immediately before and after the intervention.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • Poland
    • Podkarpackie
      • Rzeszów, Podkarpackie, Poland, 35-310 Rzeszów
        • Laboratorium Czynników Fizykalnych w Rehabilitacji w Przyrodniczo-Medycznym Centrum Badań Innowacyjnych Uniwersytetu Rzeszowskiego

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Informed voluntary consent to participate in the study
  2. II ° and III ° of advancement of radiological changes
  3. II ° and III ° of advancement of functional changes
  4. Remission, low or moderate RA activity: DAS28
  5. Medical referral for physiotherapy treatment

Exclusion Criteria:

  1. Additional physiotherapy treatments for the hands
  2. Contraindications for magnetotherapy treatments
  3. Lack of informed, voluntary consent to participate in 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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Kinesiotherapy with Static Magnetic Field
Patients have kinesiotherapy of hand and static magnetic field. All patients without steroid anti-inflammatory drugs.
Other: Kinesiotherapy with magnetotherapy
Individual kinesiotherapy. Parameters of magnetic field: 7 mT, f= 10-20 Hz, type of impulse: bipolar, rectangular pulse
Other Names:
  • Kinesiotherapy with static magnetic field
  • Kinesiotherapy with low-frequency pulsed magnetic field
Experimental: Kinesiotherapy with low-frequency pulsed magnetic field
Patients have kinesiotherapy of hand and low-frequency pulsed magnetic field. All patients without steroid anti-inflammatory drugs.
Other: Kinesiotherapy with magnetotherapy
Individual kinesiotherapy. Parameters of magnetic field: 7 mT, f= 10-20 Hz, type of impulse: bipolar, rectangular pulse
Other Names:
  • Kinesiotherapy with static magnetic field
  • Kinesiotherapy with low-frequency pulsed magnetic field

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale
Time Frame: Change from baseline VAS value immediately after therapy.
Pain severity rating scale. only one value. Minimum value is 0, maximum value is 10. The best is 0, the worst is 10.
Change from baseline VAS value immediately after therapy.
Health Assesment Questionaire
Time Frame: Change from baseline HAQ-20 value immediately after therapy.
Subjective assesment of level of disability. Value of each of 8 subsections: minimum value 0, maximum value 3. total score is averaged. The best total score is 0, the worst is 3.
Change from baseline HAQ-20 value immediately after therapy.
Range of motion
Time Frame: Change from baseline range of motion value immediately after therapy.
Computerized measurement of the range of motion of the joints of the hand [mm]. A higher score value meant a greater range of motions.
Change from baseline range of motion value immediately after therapy.
Displacement hand volume measurement
Time Frame: Change from baseline volume value immediately after therapy.
Measurement of hand volume using the displacement method [mm3]. The higher score means less swelling.
Change from baseline volume value immediately after therapy.
Persistence time of morning stiffness
Time Frame: Change from baseline time of morning stiffness value immediately after therapy.
Patient's subjective assessment of the duration of morning stiffness [min]. The longer durations means more hand dysfunction.
Change from baseline time of morning stiffness value immediately after therapy.
Severity of morning stiffness
Time Frame: Change from baseline time of severity of morning stiffness value immediately after therapy.
Assessing the severity of morning stiffness using a 100-point scale. The higher score means a greater severity of morning stiffness.
Change from baseline time of severity of morning stiffness value immediately after therapy.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jolanta Zwolińska

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jolanta Zwolinska, PhD, University of Rzeszow

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 5, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Universyty of Rzeszow

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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