Magnetotherapy in Rheumatoid Arthritis Treatment

August 2, 2021 updated by: Jolanta Zwolińska

Type of Magnetic Field and the Effects of Rheumatoid Arthritis Treatment

Participants with rheumatoid arthritis with recommendation to physiotherapy.

Created 3 study groups:

  1. Only kinesiotherapy
  2. Kinesiotherapy with unipolar magnetic field
  3. Kinesiotherapy with bipolar magnetic field

Kinesiotherapy with magnetic field give better effects than only kinesiotherapy.

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.

Inclusion criteria:

  1. II ° and III ° of advancement of radiological changes
  2. II ° and III ° of advancement of functional changes
  3. Remission, low or moderate RA activity: DAS28

  4. Medical order

    1. Magnetotherapy and kinesiotherapy
    2. Kinesiotherapy
    3. Consent to participate in the study
    4. Completion of the research program

Exclusion criteria:

  1. Additional physiotherapy treatments for the hands
  2. Change in type or dose of pharmacotherapy used
  3. Taking steroid anti-inflammatory drugs
  4. Malaise and side effects in the subject

Outcome Measures:

  1. Duration of morning stiffness
  2. The degree of severity of morning stiffness
  3. Pain intensity assessment (VAS)
  4. Test Box & Blocks
  5. Measurement of the palmar surface of the hand
  6. Measuring the range of motion in the joints of the hand
  7. Measurement of compression force in a cylindrical grip
  8. Time to maintain maximum pressure during cylindrical grip
  9. Hand volume measurement
  10. HAQ-20 test

Intervention:

  1. Group 1: Only kinesiotherapy
  2. Group 2: Kinesiotherapy with bipolar magnetic field
  3. Group 3: Kinesiotherapy with unipolar magnetic field

Assessment:

  1. Immediately before start therapy
  2. Immediately after therapy (10 treatments in 2 weeks)

Study Type

Interventional

Enrollment (Actual)

62

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
    • Subcarpathian
      • Rzeszów, Subcarpathian, Poland, 35-301
        • St. Hedvig Clinical Provincial Hospital No. 2, ul. Lwowska 60

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

35 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • II ° and III ° of advancement of radiological changes
  • II ° and III ° of advancement of functional changes
  • Remission, low or moderate RA activity: DAS28
  • Medical order
  • Magnetotherapy and kinesiotherapy
  • Kinesiotherapy
  • Consent to participate in the study
  • Completion of the research program

Exclusion Criteria:

  • Additional physiotherapy treatments for the hands
  • Change in type or dose of pharmacotherapy used
  • Taking steroid anti-inflammatory drugs
  • Malaise and side effects in the subject

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Only kinesiotherapy
Patients have only kinesiotherapy of hand without steroid anti-inflammatory drugs and magnetotherapy.
Other: Kinesiotherapy with magnetotherapy
Individual kinesiotherapy. Parameters of magnetic field: 7 mT, f= 0-50 Hz, type of impulse: unipolar or bipolar, rectangular pulse
EXPERIMENTAL: Kinesiotherapy with bipolar magnetic field
Patients have kinesiotherapy of hand and bipolar magnetic field. All patients without steroid anti-inflammatory drugs.
Other: Kinesiotherapy with magnetotherapy
Individual kinesiotherapy. Parameters of magnetic field: 7 mT, f= 0-50 Hz, type of impulse: unipolar or bipolar, rectangular pulse
EXPERIMENTAL: Kinesiotherapy with unipolar magnetic field
Patients have kinesiotherapy of hand and unipolar magnetic field. All patients without steroid anti-inflammatory drugs.
Other: Kinesiotherapy with magnetotherapy
Individual kinesiotherapy. Parameters of magnetic field: 7 mT, f= 0-50 Hz, type of impulse: unipolar or bipolar, rectangular pulse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale (VAS)
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 (HAQ)
Time Frame: Change from baseline HAQ 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 value immediately after therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test Box&Blocks
Time Frame: Change from baseline number of blocks immediately after therapy.
Objective assessment of level of disability of hand. Number of blocks transfer from box 1 to box 2 during 1 minute.
Change from baseline number of blocks immediately after therapy.

Collaborators and Investigators

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

Sponsor

Jolanta Zwolińska

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)

May 20, 2020

Primary Completion (ACTUAL)

November 30, 2020

Study Completion (ACTUAL)

November 30, 2020

Study Registration Dates

First Submitted

June 7, 2020

First Submitted That Met QC Criteria

June 9, 2020

First Posted (ACTUAL)

June 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 3, 2021

Last Update Submitted That Met QC Criteria

August 2, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Magnetotherapy/ RA

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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