<?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>IRCT20230523058272N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-03</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>The effect of thecarotherapy on the range of motion in patients with frozen shoulder</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of thecarotherapy on the range of motion in patients with frozen shoulder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70319</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this clinical trial study, 30 patients with the diagnosis of adhesive capsulitis, referring to Bekayi Por polyclinic, will be randomly included in the study. Block randomization will be used to randomly assign people in the study groups (intervention group and comparison group). In this method, blocks of 6 (including three people in the intervention group and three people in the comparison group) will be used with a ratio of 1:1. Random Allocation software will be used to generate random sequences. For concealment, the random allocation concealment method will be used in such a way that the random sequences created in this method are recorded on cards and these cards will be placed in sealed envelopes in order. In order to maintain the created sequence, numbering will be done on the outer surface of the envelopes. Finally, the numbered envelopes will be placed in a folder. Then, based on the order of arrival of the eligible participants, the envelopes will be opened and the assigned group of that participant will be known, Blinding description: In this study, according to the way the treatment process is performed under the supervision of the researcher and is performed for the patients using the Tekar therapy device, the patients and the researcher were aware of the grouping. Of course, at the end of the design, before the data analysis by the analyzer, the names of the groups are changed to groups A and B so that the analyzer does not know about the grouping of patients.</study_design>
      <phase>3</phase>
      <hc_freetext>Adhesive capsulitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For 6 weeks, three sessions per week will be treated with tecarotherapy along with oral NSAID treatment and topical ointment. Intervention 2: Control group: In the control group, they will only be treated with oral NSAID and topical ointment.</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:
Only a part of the data, such as the information related to the main outcome or the like, can be shared

When:
The access period starts 6 months after the results are published

To whom:
Researchers working in academic and scientific institutions

Conditions:
The data will be available only to researchers working in academic and scientific institutions

Where to obtain:
Atefeh Rezaian abarqueiو dr.arezoorezayan@gmail.com

How to obtain:
Only the data related to the main results of the study can be presented to the mentioned people after mentioning the valid reason.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Atefeh Rezaian abarquei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Physical Medicine, Shahid Sadoughi Hospital, ebne Sina Boulevard, Yazd, Iran.</address>
        <city>YAZD</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915887857</zip>
        <telephone>+98 35 3837 4591</telephone>
        <email>dr.arezoorezayan@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Atefeh Rezaian abarquei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Physical Medicine, Shahid Sadoughi Hospital, ebne Sina Boulevard, Yazd, Iran.</address>
        <city>YAZD</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915887857</zip>
        <telephone>+98 35 3837 4591</telephone>
        <email>dr.arezoorezayan@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients diagnosed with adhesive capsulitis by a physical medicine specialist who are in the first or second phase of frozen shoulder.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>With a history of diabetes, blood pressure, malignancy and fractures
A cyst or lesion in the shoulder area
Contraindications for performing modalities (photoallergy) for patients with bilateral shoulder involvement
Shoulder arthritis
Calcific tendonitis
History of significant trauma
Previous shoulder surgery
infection
Rheumatoid Arthritis
Radiculopathy and/or sympathetic reflex dystrophy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: For 6 weeks, three sessions per week will be treated with tecarotherapy along with oral NSAID treatment and topical ointment.</i_keyword>
      <i_keyword>Control group: In the control group, they will only be treated with oral NSAID and topical ointment</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Vas. Timepoint: At the beginning of the study, the third and sixth weeks. Method of measurement: Using a ten-point scale to measure pain.</prim_outcome>
      <prim_outcome>Spadi. Timepoint: At the beginning of the study, the third and sixth weeks. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>ROM. Timepoint: At the beginning of the study, the third and sixth weeks. Method of measurement: Examination.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-11-16</approval_date>
        <contact_name>Shahid Sadoughi University of Medical Sciences, Yazd</contact_name>
        <contact_address>Department of Physical Medicine, Shahid Sadoughi Hospital, ebne Sina Boulevard, Yazd, Iran. yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
