<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04426513</url>
  </required_header>
  <id_info>
    <org_study_id>Magnetotherapy/ RA</org_study_id>
    <nct_id>NCT04426513</nct_id>
  </id_info>
  <brief_title>Magnetotherapy in Rheumatoid Arthritis Treatment</brief_title>
  <official_title>Type of Magnetic Field and the Effects of Rheumatoid Arthritis Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jolanta Zwolińska</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Rzeszow</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Participants with rheumatoid arthritis with recommendation to physiotherapy.&#xD;
&#xD;
      Created 3 study groups:&#xD;
&#xD;
        1. Only kinesiotherapy&#xD;
&#xD;
        2. Kinesiotherapy with unipolar magnetic field&#xD;
&#xD;
        3. Kinesiotherapy with bipolar magnetic field&#xD;
&#xD;
      Kinesiotherapy with magnetic field give better effects than only kinesiotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants with rheumatoid arthritis with recommendation to physiotherapy. All participants&#xD;
      have dysfunction and pain of hand.&#xD;
&#xD;
      Inclusion criteria:&#xD;
&#xD;
        1. II ° and III ° of advancement of radiological changes&#xD;
&#xD;
        2. II ° and III ° of advancement of functional changes&#xD;
&#xD;
        3. Remission, low or moderate RA activity: DAS28&#xD;
&#xD;
        4. Medical order&#xD;
&#xD;
             1. Magnetotherapy and kinesiotherapy&#xD;
&#xD;
             2. Kinesiotherapy&#xD;
&#xD;
             3. Consent to participate in the study&#xD;
&#xD;
             4. Completion of the research program&#xD;
&#xD;
      Exclusion criteria:&#xD;
&#xD;
        1. Additional physiotherapy treatments for the hands&#xD;
&#xD;
        2. Change in type or dose of pharmacotherapy used&#xD;
&#xD;
        3. Taking steroid anti-inflammatory drugs&#xD;
&#xD;
        4. Malaise and side effects in the subject&#xD;
&#xD;
      Outcome Measures:&#xD;
&#xD;
        1. Duration of morning stiffness&#xD;
&#xD;
        2. The degree of severity of morning stiffness&#xD;
&#xD;
        3. Pain intensity assessment (VAS)&#xD;
&#xD;
        4. Test Box &amp; Blocks&#xD;
&#xD;
        5. Measurement of the palmar surface of the hand&#xD;
&#xD;
        6. Measuring the range of motion in the joints of the hand&#xD;
&#xD;
        7. Measurement of compression force in a cylindrical grip&#xD;
&#xD;
        8. Time to maintain maximum pressure during cylindrical grip&#xD;
&#xD;
        9. Hand volume measurement&#xD;
&#xD;
       10. HAQ-20 test&#xD;
&#xD;
      Intervention:&#xD;
&#xD;
        1. Group 1: Only kinesiotherapy&#xD;
&#xD;
        2. Group 2: Kinesiotherapy with bipolar magnetic field&#xD;
&#xD;
        3. Group 3: Kinesiotherapy with unipolar magnetic field&#xD;
&#xD;
      Assessment:&#xD;
&#xD;
        1. Immediately before start therapy&#xD;
&#xD;
        2. Immediately after therapy (10 treatments in 2 weeks)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 20, 2020</start_date>
  <completion_date type="Actual">November 30, 2020</completion_date>
  <primary_completion_date type="Actual">November 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analogue Scale (VAS)</measure>
    <time_frame>Change from baseline VAS value immediately after therapy</time_frame>
    <description>Pain severity rating scale. only one value. Minimum value is 0, maximum value is 10. The best is 0, the worst is 10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Health Assesment Questionaire (HAQ)</measure>
    <time_frame>Change from baseline HAQ value immediately after therapy</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Test Box&amp;Blocks</measure>
    <time_frame>Change from baseline number of blocks immediately after therapy.</time_frame>
    <description>Objective assessment of level of disability of hand. Number of blocks transfer from box 1 to box 2 during 1 minute.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <condition>Hand Rheumatism</condition>
  <arm_group>
    <arm_group_label>Only kinesiotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients have only kinesiotherapy of hand without steroid anti-inflammatory drugs and magnetotherapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Kinesiotherapy with bipolar magnetic field</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients have kinesiotherapy of hand and bipolar magnetic field. All patients without steroid anti-inflammatory drugs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Kinesiotherapy with unipolar magnetic field</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients have kinesiotherapy of hand and unipolar magnetic field. All patients without steroid anti-inflammatory drugs.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Kinesiotherapy with magnetotherapy</intervention_name>
    <description>Individual kinesiotherapy. Parameters of magnetic field: 7 mT, f= 0-50 Hz, type of impulse: unipolar or bipolar, rectangular pulse</description>
    <arm_group_label>Kinesiotherapy with bipolar magnetic field</arm_group_label>
    <arm_group_label>Kinesiotherapy with unipolar magnetic field</arm_group_label>
    <arm_group_label>Only kinesiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  II ° and III ° of advancement of radiological changes&#xD;
&#xD;
          -  II ° and III ° of advancement of functional changes&#xD;
&#xD;
          -  Remission, low or moderate RA activity: DAS28&#xD;
&#xD;
          -  Medical order&#xD;
&#xD;
          -  Magnetotherapy and kinesiotherapy&#xD;
&#xD;
          -  Kinesiotherapy&#xD;
&#xD;
          -  Consent to participate in the study&#xD;
&#xD;
          -  Completion of the research program&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Additional physiotherapy treatments for the hands&#xD;
&#xD;
          -  Change in type or dose of pharmacotherapy used&#xD;
&#xD;
          -  Taking steroid anti-inflammatory drugs&#xD;
&#xD;
          -  Malaise and side effects in the subject&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>St. Hedvig Clinical Provincial Hospital No. 2, ul. Lwowska 60</name>
      <address>
        <city>Rzeszów</city>
        <state>Subcarpathian</state>
        <zip>35-301</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <reference>
    <citation>Richmond SJ. Magnet therapy for the relief of pain and inflammation in rheumatoid arthritis (CAMBRA): a randomised placebo-controlled crossover trial. Trials. 2008 Sep 12;9:53. doi: 10.1186/1745-6215-9-53.</citation>
    <PMID>18789135</PMID>
  </reference>
  <reference>
    <citation>Zwolinska J, Gasior M, Sniezek E, Kwolek A. The use of magnetic fields in treatment of patients with rheumatoid arthritis. Review of the literature. Reumatologia. 2016;54(4):201-206. doi: 10.5114/reum.2016.62475. Epub 2016 Oct 5.</citation>
    <PMID>27826175</PMID>
  </reference>
  <reference>
    <citation>Nasonov VA, Murav'ev IuV, Kuz'mina NN. [Can local therapy of joint syndrome with Dolgit cream be used as an alternative to systemic nonsteroid antiinflammatory drugs in rheumatic diseases?]. Ter Arkh. 1998;70(11):64-6. Russian.</citation>
    <PMID>9949465</PMID>
  </reference>
  <reference>
    <citation>Srikesavan C, Williamson E, Cranston T, Hunter J, Adams J, Lamb SE. An Online Hand Exercise Intervention for Adults With Rheumatoid Arthritis (mySARAH): Design, Development, and Usability Testing. J Med Internet Res. 2018 Jun 27;20(6):e10457. doi: 10.2196/10457.</citation>
    <PMID>29950288</PMID>
  </reference>
  <reference>
    <citation>Erol K, Gok K, Cengiz G, Ozgocmen S. Hand functions in systemic sclerosis and rheumatoid arthritis and influence on clinical variables. Int J Rheum Dis. 2018 Jan;21(1):249-252. doi: 10.1111/1756-185X.13044. Epub 2017 Mar 21.</citation>
    <PMID>28322506</PMID>
  </reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 7, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>August 2, 2021</last_update_submitted>
  <last_update_submitted_qc>August 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Rzeszow</investigator_affiliation>
    <investigator_full_name>Jolanta Zwolińska</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Magnetotherapy</keyword>
  <keyword>Rheumatoid arthritis</keyword>
  <keyword>Hand function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
    <mesh_term>Rheumatic Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04426513
org study id: Magnetotherapy/ RA
nct id: NCT04426513
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Visual Analogue Scale (VAS)
time frame: Change from baseline VAS value immediately after therapy
description: Pain severity rating scale. only one value. Minimum value is 0, maximum value is 10. The best is 0, the worst is 10.
measure: Health Assesment Questionaire (HAQ)
time frame: Change from baseline HAQ value immediately after therapy
description: 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.
measure: Test Box&Blocks
time frame: Change from baseline number of blocks immediately after therapy.
description: Objective assessment of level of disability of hand. Number of blocks transfer from box 1 to box 2 during 1 minute.
arm group label: Only kinesiotherapy
arm group type: Active Comparator
description: Patients have only kinesiotherapy of hand without steroid anti-inflammatory drugs and magnetotherapy.
arm group label: Kinesiotherapy with bipolar magnetic field
arm group type: Experimental
description: Patients have kinesiotherapy of hand and bipolar magnetic field. All patients without steroid anti-inflammatory drugs.
arm group label: Kinesiotherapy with unipolar magnetic field
arm group type: Experimental
description: Patients have kinesiotherapy of hand and unipolar magnetic field. All patients without steroid anti-inflammatory drugs.
intervention type: Other
intervention name: Kinesiotherapy with magnetotherapy
description: Individual kinesiotherapy. Parameters of magnetic field: 7 mT, f= 0-50 Hz, type of impulse: unipolar or bipolar, rectangular pulse
arm group label: Kinesiotherapy with bipolar magnetic field
arm group label: Kinesiotherapy with unipolar magnetic field
arm group label: Only kinesiotherapy
criteria: 
gender: All
minimum age: 35 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Poland
citation: Richmond SJ. Magnet therapy for the relief of pain and inflammation in rheumatoid arthritis (CAMBRA): a randomised placebo-controlled crossover trial. Trials. 2008 Sep 12;9:53. doi: 10.1186/1745-6215-9-53.
PMID: 18789135
citation: Zwolinska J, Gasior M, Sniezek E, Kwolek A. The use of magnetic fields in treatment of patients with rheumatoid arthritis. Review of the literature. Reumatologia. 2016;54(4):201-206. doi: 10.5114/reum.2016.62475. Epub 2016 Oct 5.
PMID: 27826175
citation: Nasonov VA, Murav'ev IuV, Kuz'mina NN. [Can local therapy of joint syndrome with Dolgit cream be used as an alternative to systemic nonsteroid antiinflammatory drugs in rheumatic diseases?]. Ter Arkh. 1998;70(11):64-6. Russian.
PMID: 9949465
citation: Srikesavan C, Williamson E, Cranston T, Hunter J, Adams J, Lamb SE. An Online Hand Exercise Intervention for Adults With Rheumatoid Arthritis (mySARAH): Design, Development, and Usability Testing. J Med Internet Res. 2018 Jun 27;20(6):e10457. doi: 10.2196/10457.
PMID: 29950288
citation: Erol K, Gok K, Cengiz G, Ozgocmen S. Hand functions in systemic sclerosis and rheumatoid arthritis and influence on clinical variables. Int J Rheum Dis. 2018 Jan;21(1):249-252. doi: 10.1111/1756-185X.13044. Epub 2017 Mar 21.
PMID: 28322506
responsible party type: Sponsor-Investigator
investigator affiliation: University of Rzeszow
investigator full name: Jolanta Zwolińska
investigator title: PhD
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Rheumatic Diseases
sharing ipd: No