<?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>IRCT20210614051583N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-20</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>The Effect of Dry Needling on Shoulder Pain and AcromioHumeral Distance</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Dry Needle Intervention on AcromioHumeral Distance and Shoulder Pain and Disability in Patient with Subacromial Pain Syndrome.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>25</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56933</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Shoulder Subacromial Pain Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Physiotherapy is performed on the painful shoulder. Physiotherapy treatment modalities include TENS, Ultrasound, and Infrared radiation. These devices include TENS Model 62L and Ultrasound Model 215A provided by Novin Medical Engineering Company. Passive, active and resistance exercises are performed for 25 minutes to increase range of motion, reduce pain and strengthen of the Serratus Anterior, Lower and Middle Trapezius, Pectoralis Major, Latissimus Dorsi, Teres Major, Deltoid, Supraspinatus, Infraspinatus, Teres Minor muscles. Intervention 2: Intervention group: In the intervention group, dry needling is added to physiotherapy treatment and at the end of the physiotherapy session, dry needling intervention is applied to the Levator Scapula muscles, Rhomboids as well as active trigger points found in the first, third, fifth, seventh and ninth sessions.</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:
Part of the data, such as information about the main outcome, can be shared.

When:
Access period starts 6 months after the results are published

To whom:
It will be available only to researchers working in academic and scientific institutions

Conditions:
Scientific research

Where to obtain:
mohammadi_pt@yahoo.com

How to obtain:
One month after receiving the email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Jamshid Mohammadiasl</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 18, Shafagh Avenue, hajizadeh St., East Payambar St., Dist.5, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1471755741</zip>
        <telephone>+98 21 4497 4770</telephone>
        <email>mohammadi_pt@yahoo.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Jamshid Mohammadiasl</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 18, Shafagh Avenue, hajizadeh St., East Payambar St., Dist.5, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1471755741</zip>
        <telephone>+98 21 4497 4770</telephone>
        <email>mohammadi_pt@yahoo.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People with subacromial shoulder pain syndrome
Decreased subacromial space</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of fractures and dislocations in the scapula and shoulder area
History of scapula and shoulder surgery
Neurological symptoms in the upper extremities such as sensory and motor disorders
Frozen shoulder and severe neck pain
Congenital skeletal abnormalities
Inflammatory joint disease such as rheumatoid arthritis
Performing treatments such as dry needling, topical corticosteroids injection, PRP and ozone therapy during the last 3 months
Fear of needles and taking Anticoagulant for dry needle group</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M25.51</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pain in shoulder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Physiotherapy is performed on the painful shoulder. Physiotherapy treatment modalities include TENS, Ultrasound, and Infrared radiation. These devices include TENS Model 62L and Ultrasound Model 215A provided by Novin Medical Engineering Company. Passive, active and resistance exercises are performed for 25 minutes to increase range of motion, reduce pain and strengthen of the Serratus Anterior, Lower and Middle Trapezius, Pectoralis Major, Latissimus Dorsi, Teres Major, Deltoid, Supraspinatus, Infraspinatus, Teres Minor muscles.</i_keyword>
      <i_keyword>Intervention group: In the intervention group, dry needling is added to physiotherapy treatment and at the end of the physiotherapy session, dry needling intervention is applied to the Levator Scapula muscles, Rhomboids as well as active trigger points found in the first, third, fifth, seventh and ninth sessions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Shoulder pain. Timepoint: Before the intervention, after the end of the intervention and 3 months after the end of the intervention. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Shoulder disability. Timepoint: Before the intervention, after the end of the intervention and 3 months after the end of the intervention. Method of measurement: Shoulder Pain And Disability Index.</prim_outcome>
      <prim_outcome>Upper extremity disability. Timepoint: Before the intervention, after the end of the intervention and 3 months after the end of the intervention. Method of measurement: The Disabilities of the Arm, Shoulder and Hand Score (QuickDash).</prim_outcome>
      <prim_outcome>Acromiohumeral Distance. Timepoint: Before the intervention, after the end of the intervention and 3 months after the end of the intervention. Method of measurement: Sonography.</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>University of social welfare and rehabilitation sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-19</approval_date>
        <contact_name>Research Ethic Committee of University of Social Welfare and Rehabilitation Science</contact_name>
        <contact_address>No. 18, Shafagh Alley, Hajizadeh St. West Payambar St., Dist.5 Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
