<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20231007059642N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-22</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of electromagnetism in reducing knee osteoarthritis symptoms</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effectiveness of electromagnetic therapy on improving the symptoms of second and third degree knee osteoarthritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73026</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A simple randomization method is used. Sampling will be done by the method of alternating blocks of 2 in such a way that we will have 10 blocks of 3 and each block will contain 3 letters from the letters A and B, including AAB-ABA-BBA-BAB and..... (two groups of 30 Each patient is randomly given a card, the cards are in sealed envelopes, and the technician takes the envelopes in order and delivers them to the patients, Blinding description: Random Allocation version 2 software will be used.
Sampling will be done by the method of 2 permutation blocks in such a way that we will have 10 blocks of 4 and each block contains 4 letters from letters A and B including AABB-ABAB-BBAA-BABA and..... (two groups of 40) one card for each patient randomly It is given that the cards are in sealed envelopes and the technician takes the envelopes in order and delivers them to the patients.
Due to the nature of the study, it is not possible to blind the patients.
The person who collects the data does not know whether the data belongs to group A or group B.
The person who analyzes the data does not know whether he belongs to group A or group B.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Knee osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this group, drug treatment with 1 tablet of meloxicam 15mg once a day for 18 days and exercise therapy 3 times a day for 18 days, each for 20 seconds and 3 times each time.Sports include the following:Stretching of quadriceps and calf muscle, strengthening of quadriceps and hamesteringIn addition to drug therapy and exercise, the group is performed using the magno 915G device, made in Iran, located in the physical medicine and rehabilitation department of Amin Hospital. The number of PEMF sessions is 8 sessions, 3 times a week. The patient is in a supine position. The back (SUPINE) is placed on the bed. Then the entire knee area will be placed under the electromagnet device. The total treatment time per session is 30 minutes. Intervention 2: Control group:In this group, drug treatment with 1 tablet of meloxicam 15mg once a day for 18 days and exercise therapy 3 times a day for 18 days, each for 20 seconds and 3 times each time.Sports include the following:Stretching of quadriceps and calf muscle, strengthening of quadriceps and hamesteringIn this group, the magnet device is turned off for the patient.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saeideh Safinataj</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 5, Hafez Building, 4th dead end on the right, 28 Yavar Alley,Barazande Street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8193967748</zip>
        <telephone>+98 913 347 5411</telephone>
        <email>saeide.safi@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saeideh Safinataj</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 5,hafez building,Right side of the 4th deadend,Yavar 28 alley,Barazandeh street</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8193967748</zip>
        <telephone>+98 913 347 5411</telephone>
        <email>saeide.safi@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Primary diagnosis of grade 2 and 3 OA based on ACR criteria, including radiological evidence, clinical examination and history
Age ≥40 years
The presence of dry knee symptoms and frequent daily pain since 6 months ago
Symptomatic illness from at least 6 months ago
Presence of pain with VAS ≥3 criteria</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Intra-articular drug administration in the last 6 months
Systemic treatment with corticosteroids or physical therapy in the last 6 weeks
Cartilaginous consumption in the last 6 weeks
Back radicular pains
Knee pain caused by malignant, autoimmune and inflammatory pathology or caused by knee deformities such as genovarus and genovalgus etc.
Patients who have a history of knee surgery
Lack of cooperation and difficulty in referring and following the intervention process
pregnancy
Metal implant like heart pacemaker</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M17</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Osteoarthritis of knee</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this group, drug treatment with 1 tablet of meloxicam 15mg once a day for 18 days and exercise therapy 3 times a day for 18 days, each for 20 seconds and 3 times each time.Sports include the following:Stretching of quadriceps and calf muscle, strengthening of quadriceps and hamesteringIn addition to drug therapy and exercise, the group is performed using the magno 915G device, made in Iran, located in the physical medicine and rehabilitation department of Amin Hospital. The number of PEMF sessions is 8 sessions, 3 times a week. The patient is in a supine position. The back (SUPINE) is placed on the bed. Then the entire knee area will be placed under the electromagnet device. The total treatment time per session is 30 minutes.</i_keyword>
      <i_keyword>Control group:In this group, drug treatment with 1 tablet of meloxicam 15mg once a day for 18 days and exercise therapy 3 times a day for 18 days, each for 20 seconds and 3 times each time.Sports include the following:Stretching of quadriceps and calf muscle, strengthening of quadriceps and hamesteringIn this group, the magnet device is turned off for the patient.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Symptoms of knee osteoarthritis. Timepoint: before, immediately and 6 weeks and 3 months after the end of the treatment. Method of measurement: Visual Analogue Scale and Western Ontario and McMaster Universities Osteoarthritis Index scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Average pain intensity. Timepoint: Before, immediately and 6 weeks and 3 months after the end of the treatment. Method of measurement: Visual Analogue Scale.</sec_outcome>
      <sec_outcome>Physical performance. Timepoint: Before, immediately and 6 weeks and 3 months after the end of the treatment. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index.</sec_outcome>
      <sec_outcome>Joint dryness. Timepoint: Before, immediately and 6 weeks and 3 months after the end of the treatment. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index.</sec_outcome>
      <sec_outcome>Range of motion. Timepoint: Before, immediately and 6 weeks and 3 months after the end of the treatment. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-10-03</approval_date>
        <contact_name>Ethical Committee of Isfahan University of Medical Sciences, Faculty of Medicine</contact_name>
        <contact_address>Unit 5, Hafez Building, 4th dead end on the right, 28 Yavar Alley, Barazandeh Street Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
