<?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>IRCT20100605004104N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-06</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Effects of Acromioclavicular joint mobilization in Frozen Shoulder Syndrome</public_title>
      <acronym></acronym>
      <scientific_title>: Effects of Acromioclavicular joint mobilization on symptoms and functional disability in patients with Frozen Shoulder Syndrome: A randomized controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35900</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will divide randomly into2 groups (A,B) by computerized randomization with Excel software and this sequence will be written in separate envelopes and then will be placed in a box. The patients will treat with sequence of this box, Blinding description: For concealment of allocation and we will write sequence (A,B) based on computerized randomization in separate pockets and will be placed in a box. The patients will treat with sequence of this box. No researcher and statistical analyst will be aware of the type of intervention received.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Frozen shoulder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Acromioclavicular joint mobilization techniques will be performed in the form of passive accessory inferior ,posterior to anterior &amp; anterior to posterior glides( grade 3 &amp;4) ,of the distal end of the clavicle in physiological position for up to 6 sessions in the course of therapy by one expert therapist. patients also will receive physiotherapy and exercise such as control group. Intervention 2: Control group: They will receive 10 sessions of shoulder physiotherapy three times a week with range of motion,stretching and isometric strengthening  exercises of  shoulder muscles at home  twice a day for twenty days that will be conducted in a pain free manner. physiotherapy includes: hot pack for 20 minutes with heat of 74.5 degrees Celsius. Electrical nerve stimulation with frequencies of 70 to 80 hertz for 25 minutes. Continuous ultrasonography with dose of 1.25 to 1.5 w/cm2, and range of motion and stretching exercise .</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sepideh Ranjbar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golghasht Ave., Imam Reza hospital, Physical medicine and rehabilitation department</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614756</zip>
        <telephone>+98 41 3336 1928</telephone>
        <email>Sepideh_R_k@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Mohammad Rahbar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golghasht Ave., Imam Reza hospital, Department of Physical Medicine and Rehabilitation</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614756</zip>
        <telephone>+98 33361928</telephone>
        <email>rahbarm@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 18 to 60 years
Unilateral frozen shoulder
Normal shoulder Xray and  normal neurological examination
At least two months passing from the onset of symptoms</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Inflammatory or infectious shoulder joint disease
Neurological deficit such as stroke which is due to shoulder muscle dysfunction
Poor controlled diabetes
Neoplastic disorder of shoulder region
A recent history of fracture, dislocation or subluxation of shoulder complex
A history of steroid injection of glenohumeral joint, subdeltoid burse or acromiocalvicular joint within the previous 6 months or surgery
A feeling of instability at the glenohumeral joint
Shoulder pain referred from the severe cervical radiculopathy.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M75.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Adhesive capsulitis of shoulder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Acromioclavicular joint mobilization techniques will be performed in the form of passive accessory inferior ,posterior to anterior &amp; anterior to posterior glides( grade 3 &amp;4) ,of the distal end of the clavicle in physiological position for up to 6 sessions in the course of therapy by one expert therapist. patients also will receive physiotherapy and exercise such as control group.</i_keyword>
      <i_keyword>Control group: They will receive 10 sessions of shoulder physiotherapy three times a week with range of motion,stretching and isometric strengthening  exercises of  shoulder muscles at home  twice a day for twenty days that will be conducted in a pain free manner. physiotherapy includes: hot pack for 20 minutes with heat of 74.5 degrees Celsius. Electrical nerve stimulation with frequencies of 70 to 80 hertz for 25 minutes. Continuous ultrasonography with dose of 1.25 to 1.5 w/cm2, and range of motion and stretching exercise .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Ability to manage in everyday life. Timepoint: before treatment, immediately after treatment. Method of measurement: Shoulder Pain and Disability Index Questionnaire.</prim_outcome>
      <prim_outcome>Range of motion of shoulder joints. Timepoint: before treatment and immediately after treatment. Method of measurement: Goniometer.</prim_outcome>
      <prim_outcome>Pain  severity. Timepoint: Before treatment, immediately after treatment. Method of measurement: Visual Analogue Scale with grading from zero to 10 centimeters.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-11-19</approval_date>
        <contact_name>Ethic committee of Tabriz Univercity of Medicine</contact_name>
        <contact_address>Golgasht Street, Central Department no.2, Vice Chancellor for Research, Tabriz University of Medical Sciences Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
