<?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>IRCT20100718004409N13</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-24</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of acupuncture on the patients who have shoulder pain</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of acupuncture on pain and function of the patients who have shoulder pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46491</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The included patients will be randomized in a simple randomization method. The random number tables found in the most statistical text books will be used for the random numbers. The numbers between 0-23 are considered for the first group, 24-47 for the second group and 48 -73for the third group. The 3 groups are 1- Acupuncture, 2- Sham &amp; 3- Exercise therapy.  concealment is performed in sequentially numbered, sealed &amp; opaque envelopes, and will be kept by the department secretory, Blinding description: After randomization the patients of the each group will be introduced to the researcher 2 by the researcher 1 for evaluation of the outcomes. The researcher 2 only evaluates the outcomes and records the findings without
  being informed of the intervention and its effects. The analyzer receives the data at the end of the study and  is not informed of the intervention groups at all.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: rotator cuff tendinopathy, partial tear of rotator cuff. Condition 2: Shoulder impingement.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: Accupuncture group are needled in accupuncture points in shoulder , 20 millimeter deep inside the skin ,3 sessions a week for 10 session .each session is 10 minutes. Intervention 2: Intervention group2: Sham accupuncture group are needled in accupuncture points in shoulder ,With distance 20 centimeter of main points ,10 millimeter deep inside the skin ,3 sessions a week for 10 session .each session is 10 minutes. Intervention 3: Control group:  In exercise group , streching exercise for shoulder ,isometric exercises and passive range of motion each session 3 set 10 repetition daily and strengthening exercises and progressive strengthening exercises ,each session 3 set 10 repetition daily for 6 weeks.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Unawareness of this item</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parisa Nejati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rasool hospital, Niayesh st.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613131</zip>
        <telephone>+98 21 6651 5001</telephone>
        <email>parisanejati2@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Parisa Nejati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rasool hospital, Niayesh street, Sattarkhan street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613131</zip>
        <telephone>+98 21 6651 5001</telephone>
        <email>parisanejati@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Shoulder pain lasted more than 6 weeks
At least 3 positive specific shoulder tests
MRI findings implying tendinopathy or partial tear of rotator cuff</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The presence of sensory or motor disturbances  in the upper extremity
Evidence from other pathologies that can lead to shoulder pain. For example, the presence of calcified tendonitis or adhesive capsulitis and ...
History of shoulder surgery in the last 6 months
The presence of inflammatory rhomatologic diseases such as rheumatoid arthritis, fibromyalgia, poly mialia rheumatica and ...
Complete rupture of rotator cuff tendons based on MRI findings
History of corticosteroid, analgesic or hyaluronic acid injection in the shoulder joint over the past 3 months
History of exercise therapy and physiotherapy modalities over the past 6 weeks
Use of other therapies during the intervention period
Patients request for discontinuing the treatment
Contraindications for performing MRI</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M75.1</hc_code>
      <hc_code>M75.40</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Rotator cuff tear or rupture, not specified as traumatic</hc_keyword>
      <hc_keyword>Impingement syndrome of unspecified shoulder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1: Accupuncture group are needled in accupuncture points in shoulder , 20 millimeter deep inside the skin ,3 sessions a week for 10 session .each session is 10 minutes</i_keyword>
      <i_keyword>Intervention group2: Sham accupuncture group are needled in accupuncture points in shoulder ,With distance 20 centimeter of main points ,10 millimeter deep inside the skin ,3 sessions a week for 10 session .each session is 10 minutes</i_keyword>
      <i_keyword>Control group:  In exercise group , streching exercise for shoulder ,isometric exercises and passive range of motion each session 3 set 10 repetition daily and strengthening exercises and progressive strengthening exercises ,each session 3 set 10 repetition daily for 6 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain amount. Timepoint: Before intervention, 1 ,3 ,6 months after intervention. Method of measurement: Visual Analog Scale.</prim_outcome>
      <prim_outcome>Function of the patients. Timepoint: Before intervention, 1 ,3 ,6 months after itervention. Method of measurement: Western Ontario Rotator cuff Index(WORC)questionnaires ,The Disabilities of the Arm, Shoulder, and Hand Outcome Measure (DASH) questionnaires.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Shoulder range of motion. Timepoint: Before the intervention, 1,3,6 months after intervention. Method of measurement: Goniometry.</sec_outcome>
      <sec_outcome>Rotator cuff strength. Timepoint: Before the intervention, 1,3,6 months after intervention. Method of measurement: Muscle Manual Test.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-21</approval_date>
        <contact_name>Ethic committee of Iran university of medical sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Near the Milad Tower,Hemmat highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
