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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

72

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 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

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
Intervention / Treatment
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

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

Jolanta Zwolińska

Investigators

  • 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)

March 1, 2021

Primary Completion (Actual)

November 1, 2022

Study Completion (Actual)

January 5, 2023

Study Registration Dates

First Submitted

June 16, 2023

First Submitted That Met QC Criteria

June 16, 2023

First Posted (Actual)

June 27, 2023

Study Record Updates

Last Update Posted (Actual)

July 10, 2023

Last Update Submitted That Met QC Criteria

July 6, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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