<?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>IRCT20220523054971N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-03</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effect of calcitonin in frozen shoulder treatment</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of response to calcitonin treatment in patients with frozen shoulder in selected hospitals of Islamic Azad University of Medical Sciences, Tehran in 2022</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-12-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63753</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling is based on a simple random sampling method and based on lottery, cards are prepared according to the sample volume and the desired number is recorded on each card, the cards are placed in a box, then the cards are mixed, and they get out of the box by accident and one after the other until the capacity of both groups is completed, Blinding description: After determining the samples of the combined treatment group and obtaining informed consent from them, calcitonin nasal spray is added to the common treatment of this group of patients.</study_design>
      <phase>3</phase>
      <hc_freetext>Frozen shoulder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients receiving calcitonin nasal spray in addition to common treatments; In this group of patients, intranasal calcitonin spray of 200 units is prescribed along with current common treatments such as aspirin, ibuprofen, intra-articular injection of steroids and physical therapy; the effect of this treatment method is checked from the time of administration to 6 weeks later in the form of face-to-face interview or phone call and compared with the results of the control group. Intervention 2: Control group: Patients receiving common treatments; This group of patients receives current common treatments such as aspirin, ibuprofen, intra-articular injection of steroids and physiotherapy, and the results of the intervention group are compared with the results of this group.</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:
All data can be shared after de-identifying study participants.

When:
Access to the data starts 6 months after the publication of the thesis.

To whom:
General doctors and orthopedic specialists

Conditions:
The data can be used for further research to achieve the definite effect of the treatment method, to access the data, you should talk to the scientific officer of the research.

Where to obtain:
Visit in person to Dr. Afshin farhadi at the address of Tehran, Naziabad, Shirmohammadi St., In front of Sardar Jangal Park, Amiralmomenin Javadieh Hospital, Building No. 3, Orthopedic Clinic

How to obtain:
Visit in person to obtain permission from the scientific research officer

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Afshin Farhadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amiralmomenin Hospital, In front of Sardar Jangal Park, Shirmohammadi St., Naziabad, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1811694784</zip>
        <telephone>+98 21 5534 6550</telephone>
        <email>afshinfarhadi53@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Afshin Farhadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amiralmomenin hospital, In front of Sardar Jangal Park, Shirmohammadi St., Naziabad., Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1811694784</zip>
        <telephone>+98 21 5534 6550</telephone>
        <email>afshinfarhadi53@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with a clinical diagnosis of frozen shoulder
Patients symptoms including limitation in all active and passive movements of the shoulder joint in all directions
Patients with relatively severe pain
Patients with reduction in the range of motion of the shoulder
Definite confirmation of the diagnosis with the help of MRI of the shoulder joint</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M75.00</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Adhesive capsulitis of unspecified shoulder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients receiving calcitonin nasal spray in addition to common treatments; In this group of patients, intranasal calcitonin spray of 200 units is prescribed along with current common treatments such as aspirin, ibuprofen, intra-articular injection of steroids and physical therapy; the effect of this treatment method is checked from the time of administration to 6 weeks later in the form of face-to-face interview or phone call and compared with the results of the control group.</i_keyword>
      <i_keyword>Control group: Patients receiving common treatments; This group of patients receives current common treatments such as aspirin, ibuprofen, intra-articular injection of steroids and physiotherapy, and the results of the intervention group are compared with the results of this group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain changes with visual analogue scale(VAS). Timepoint: 6 weeks after receiving calcitonin nasal spray. Method of measurement: Visual analogue scale.</prim_outcome>
      <prim_outcome>Changes in the range of motion with the angle scale in degrees. Timepoint: 6 weeks after receiving calcitonin nasal spray. Method of measurement: Degrees of angle.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-16</approval_date>
        <contact_name>Ethics committee of Tehran Islamic Azad University of Medical Sciences</contact_name>
        <contact_address>Headquarters Building of Tehran Islamic Azad University of Medical Sciences, Corner of Gol Yakh St., Aineh Blvd., Amir Pabarja St., Gholhak Blvd., Doctor Shariati Ave., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
