<?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>IRCT20210424051069N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-05-30</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of magnet therapy in the treatment of patients with shoulder impingement syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of electromagnetic therapy to reduce pain and disability in patients with shoulder impingement syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55812</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: Patients will be randomly assigned to 3 treatment groups. The size of the blocks will be 6 and 9. Random block allocation will be done with stata software. Concealment or allocation cover will be done using the technique of closed and opaque envelopes, so that the treatment group of eligible patients who are randomly assigned to the study will be placed in closed and opaque envelopes, respectively. In the order in which patients enter the study, the envelope corresponding to each person's entry number will be opened and he will receive the assigned treatment, Blinding description: Participants and evaluators in this study are blind. Randomization and treatment is done by another person.</study_design>
      <phase>3</phase>
      <hc_freetext>Shoulder impingement syndrome.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group: magnet therapy with a frequency of 18 Hz, Magnet therapy is 12 sessions, 3 times a week for 4 weeks. The magnitude of the magnet is 100 mT and the duration of each treatment session is 30 minutes, but the frequency is set at 18 Hz in this group. They also receive conventional electrotherapy and exercise therapy. Intervention 2: The second intervention group: magnet therapy with a frequency of 100 Hz, Magnet therapy is 12 sessions, 3 times a week for 4 weeks. The magnitude of the magnet is 100 mT and the duration of each treatment session is 30 minutes, but the frequency is set at 100 Hz in this group. They also receive conventional electrotherapy and exercise therapy. Intervention 3: Control group:  Placebo magnet therapy. Magnet therapy 12 sessions, 3 times a week for 4 weeks as a placebo. They also receive conventional electrotherapy and exercise therapy.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Information about the main data including pain intensity, questionnaire score, range of motion can be shared

When:
One month after completing the data analysis

To whom:
Scientific and academic researchers

Conditions:
In order to design similar new studies

Where to obtain:
Eterafoskouei@tbzmed.ac.ir
Zahra.Afzalifard@gmail.com

How to obtain:
Full details about the use of the requested documents will be sent to the mentioned e-mail address and if approved, it will be available as soon as possible.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mirali Eterafoskouei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Rehabilitation Sciences, next to Vahdat Hall, University of Tabriz, 29 Blvd.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614766</zip>
        <telephone>+98 41 3337 2072</telephone>
        <email>Eterafoskouei@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mirali Eterafoskouei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Rehabilitation Sciences, next to Vahdat Hall, University of Tabriz, 29 Blvd.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614766</zip>
        <telephone>+98 41 3337 2072</telephone>
        <email>eterafoskouei@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who have pain in the shoulder joint for at least one month.
There should be restrictions on at least one active shoulder movement (flexion, abduction, external and internal rotation).
Participants are in the age range of 20 to 60 years.
Get an initial DASH score of more than 45%.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Participants with neurological disorders.
Participants with injuries to the neck, elbows or hands.
Participants with rheumatoid arthritis.
Participants with heart disease.
Participants who have a history of previous upper limb surgery.
Women who are pregnant.
People who have received intra-articular anti-inflammatory drugs in the last 60 days.
Participants with pathological shoulder disorders such as hooked acromion, osteoarthritis, adhesive capsulitis or traumatic labrum tears.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M75.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Impingement syndrome of shoulder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group: magnet therapy with a frequency of 18 Hz, Magnet therapy is 12 sessions, 3 times a week for 4 weeks. The magnitude of the magnet is 100 mT and the duration of each treatment session is 30 minutes, but the frequency is set at 18 Hz in this group. They also receive conventional electrotherapy and exercise therapy.</i_keyword>
      <i_keyword>The second intervention group: magnet therapy with a frequency of 100 Hz, Magnet therapy is 12 sessions, 3 times a week for 4 weeks. The magnitude of the magnet is 100 mT and the duration of each treatment session is 30 minutes, but the frequency is set at 100 Hz in this group. They also receive conventional electrotherapy and exercise therapy.</i_keyword>
      <i_keyword>Control group:  Placebo magnet therapy. Magnet therapy 12 sessions, 3 times a week for 4 weeks as a placebo. They also receive conventional electrotherapy and exercise therapy.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain, disability, shoulder range of motion. Timepoint: Measurement of pain, disability and shoulder range of motion at the beginning of the study (before the intervention) and after the end of treatment sessions (12th session). Method of measurement: Visual Analogue Scale; Disabilities of the Arm, Shoulder and Hand questionnaire; Goniometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Gender, age, height, weight, occupation, hand dominance. Timepoint: Before the intervention. Method of measurement: Questionnaire, meter, Weighing scale.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-04-24</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Faculty of Rehabilitation Sciences, next to Vahdat Hall, University of Tabriz, 29 Blvd. Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
