<?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>IRCT20211229053567N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-17</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of rotational and elevatory resistive exercises on acromiohumeral distance in patients with shoulder impingement syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of rotational and elevatory resistive exercises on acromiohumeral distance in people with shoulder impingement syndrome: A randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>54</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60979</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples are randomly assigned using the Stratified Permuted Block Randomization method with 6 9 blocks assigned to three groups. In this method, A will represent group one (rotational resistance exercises), B will represent group two (elevatory resistance exercises) and C will represent the control group. In this way, the order of interventions A, B and C in the form of blocks from 1 to 6 is determined by the methodological consultant of the project, and is provided to the executive supervisor of the project, and the researcher obtains an assignment from the executive supervisor to assign each qualified person. Slowly The supervisor first selects the block using a random number generator (or dice) and then the eligible individuals are assigned to one of three groups A, B or C in a predetermined order. It should be noted that if a block is selected based on random numbers that have already filled all 9 sequences, another random number will be selected again for that person.</study_design>
      <phase>N/A</phase>
      <hc_freetext>shoulder impingement syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Rotational shoulder resistance exercises are performed three times a week for 6 consecutive weeks, including 1) The patient is placed in a sitting position on a chair and the therapist stands on the affected side and the patient's elbow is placed at 90 degrees flexion. The patient moves the internal rotation of the arm from the end of the external rotation range to the end of the internal rotation range against the therapist's resistance. In order to prevent compensatory movements in the shoulder, the therapist holds the patient's elbow steady with one hand and applies resistance with the other hand on the end of the patient's forearm. The patient stands and elbows are placed at 90 degrees of flexion. The patient moves the external rotation of the arm from the end of the internal rotation range to the end of the external rotation range against the therapist's resistance. In order to prevent compensatory movements in the shoulder, the therapist holds the patient's elbow with one hand and applies resistance with the other hand on the end of the patient's forearm. 3) The patient is placed in a sitting position and the therapist is on the affected side Stand and elbow at 90 degrees flexion. The patient is asked to place the shoulder at angles of 30, 90, and 150 degrees around the scapula, and then the therapist applies force to the end of the patient's forearm to create internal rotation and external rotation of the arm, and the patient is asked to contract. Keep the shoulder isometric in the same position. In order to prevent compensatory movements in the shoulder, the therapist holds the patient's elbow with his hand. Intervention 2: Intervention group 2: elevatory shoulder resistance exercises are performed three sessions per week for 6 consecutive weeks, including 1) the patient is sitting on a chair and the therapist is standing on the affected side. The elbow is slightly bent at the flexion and thumb to create an external rotation in the arm facing the ceiling. The patient is then asked to move his or her process on the scapula to an angle of 150 degrees against resistance by the therapist. In order to apply the resistance force, the therapist's hand is placed on the end of the patient's forearm. 2) The patient is placed in a sitting position and the therapist stands on the affected side. The elbow is slightly bent at the flexion and thumb to create an external rotation in the arm facing the ceiling. The patient is asked to place the shoulder at 30, 90, and 150 degrees of rotation at the scapula, and then the therapist randomly applies force to the patient's forearm to raise and lower the patient's shoulder, and the patient is asked to contract. Maintain the isometric shoulder in the same position.</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 more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Cyrus Taghizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Semnan University of Medical Sciences, Basij Blvd, Semnan city</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>35147-99442</zip>
        <telephone>+98 23 3344 1022</telephone>
        <email>info@semums.ac.ir</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Syrus Taghizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Semnan University of Medical Sciences.Basij Blvd, Semnan city</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>35147-99442</zip>
        <telephone>+98 23 3344 1022</telephone>
        <email>info@semums.ac.ir</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Aged 17 to 35 years
History of pain in anterior and lateral of the upper shoulder that has lasted more than a week in the last six months
Having at least three of the following: Positive Neer test ;Positive Hawkins-kennedy test ;Positive Job test ;Painful arch during flexion and abduction movements ;Pain during resisted lateral rotation and / or resisted abduction</inclusion_criteria>
      <agemin>17 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Body mass index (BMI) above 25 kg/m2.
Complete rupture of the rotator cuff
Moderate to severe glenohumeral or acromioclavicular joint osteoarthritis
Glenohumeral joint instability including previous dislocation or subluxation
Previous shoulder fracture
Neurological defect of the upper limb
Systemic diseases such as rheumatoid arthritis
Neck pain with somatic or radicular pain pattern
Previous history of shoulder surgery
Corticosteroid injection in the shoulder during the last month
Loss of range of motion of the shoulder joint (for example due to adhesions)
Malignancy and hemophilia
Deformity in the shoulder
Osteoporosis
Any history of damage to the brachial plexus
Any subcutaneous inflammation</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Rotational shoulder resistance exercises are performed three times a week for 6 consecutive weeks, including 1) The patient is placed in a sitting position on a chair and the therapist stands on the affected side and the patient's elbow is placed at 90 degrees flexion. The patient moves the internal rotation of the arm from the end of the external rotation range to the end of the internal rotation range against the therapist's resistance. In order to prevent compensatory movements in the shoulder, the therapist holds the patient's elbow steady with one hand and applies resistance with the other hand on the end of the patient's forearm. The patient stands and elbows are placed at 90 degrees of flexion. The patient moves the external rotation of the arm from the end of the internal rotation range to the end of the external rotation range against the therapist's resistance. In order to prevent compensatory movements in the shoulder, the therapist holds the patient's elbow with one hand and applies resistance with the other hand on the end of the patient's forearm. 3) The patient is placed in a sitting position and the therapist is on the affected side Stand and elbow at 90 degrees flexion. The patient is asked to place the shoulder at angles of 30, 90, and 150 degrees around the scapula, and then the therapist applies force to the end of the patient's forearm to create internal rotation and external rotation of the arm, and the patient is asked to contract. Keep the shoulder isometric in the same position. In order to prevent compensatory movements in the shoulder, the therapist holds the patient's elbow with his hand.</i_keyword>
      <i_keyword>Intervention group 2: elevatory shoulder resistance exercises are performed three sessions per week for 6 consecutive weeks, including 1) the patient is sitting on a chair and the therapist is standing on the affected side. The elbow is slightly bent at the flexion and thumb to create an external rotation in the arm facing the ceiling. The patient is then asked to move his or her process on the scapula to an angle of 150 degrees against resistance by the therapist. In order to apply the resistance force, the therapist's hand is placed on the end of the patient's forearm. 2) The patient is placed in a sitting position and the therapist stands on the affected side. The elbow is slightly bent at the flexion and thumb to create an external rotation in the arm facing the ceiling. The patient is asked to place the shoulder at 30, 90, and 150 degrees of rotation at the scapula, and then the therapist randomly applies force to the patient's forearm to raise and lower the patient's shoulder, and the patient is asked to contract. Maintain the isometric shoulder in the same position.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Acromiohumeral distance. Timepoint: Before the intervention and after the intervention. Method of measurement: Ultrasonography device.</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>Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-12-28</approval_date>
        <contact_name>Ethics Committees of Semnan University Of Medical Sciences and Health Services</contact_name>
        <contact_address>Semnan university of medical sciences , Basij Blvd , Semnan city Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
