<?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>IRCT20190909044734N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-20</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of dry needling of the rotator cuff muscles on the stability and function of the upper limb in people with shoulder pain.</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of rotator cuff trigger points dry needling on the stability and function of the upper limb in people with shoulder pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70455</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using of randomization software, 40 numbers are considered for each case and the software defines 10 blocks of 4, from 4 to 2 people in the dry needling group and 2 people in sham dry needling. They are dried and thus 40 people are completed, Blinding description: The person who will evaluate the patients and analyze the data is completely unaware of the details of the patient grouping and the treatments performed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Shoulder pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: dry needling: people with shoulder pain who received 3 dry needling sessions per week according to the routine of the control group3 times during a week of treatment (one day in between), in the trigger points of the rotator cuff muscles (supraspinatus, infraspinatus, subscapularis and teres minor). Intervention 2: Control group: sham dry needling group: people with shoulder pain who received dry needling in the rotator cuff muscles (supraspinatus, infraspinatus, subscapularis and teres minor) and practically the needle does not enter the skin.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Leila Abbasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rehabilitation Faculty , Abiverdi 1 street , Chamran Blvd</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7194733669</zip>
        <telephone>+98 71 3627 1551</telephone>
        <email>leabbasi@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Leila Abbasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Rehabilitation Sciences, Abiverdi St 1, Chamran Blvd</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7194733669</zip>
        <telephone>+98 71 3627 1551</telephone>
        <email>leabbasi@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Presence of shoulder pain for at least three months
Existence of trigger points with three characteristics: 1. Existence of a palpable knot in the skeletal muscle band.2. Existence of excessive points Irritable in taut band 3. Patients who report local or referred pain after mechanical stimulation of trigger points. (with the difference that latent trigger points become painful only after mechanical stimulation and active points even without stimulation. It is a mechanism that causes myofascial pain )
The presence of at least one trigger point in two of the four rotator cuff muscles</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of shoulder and neck surgery
Instability of the glenohumeral joint and serious diseases related to the joint of cervical vertebrae,  ang glenohumeral joint
History of corticosteroid injections or local anesthetics in the past year
Symptoms indicating systemic disorders
History of any physiotherapy in the last 3 months
History of diagnosis or medical reports about the presence of myopathy and neuropathy
Cognitive problems
Patients with any limitations in dry needling treatment (fear of needles, patient dissatisfaction, lymphoedema, Acute and emergency conditions, patients with coagulation problems, immune system disorders, vascular problems, diabetes, epilepsy, allergy to metals, patients with mental disorders, use of anticoagulants)
Use of anti-platelet, anti-coagulant, anti-pain and anti-inflammatory drugs in the last three months
Cardiovascular, rheumatoid, and neurological problems
History of rotator cuff tears</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>Intervention group: dry needling: people with shoulder pain who received 3 dry needling sessions per week according to the routine of the control group3 times during a week of treatment (one day in between), in the trigger points of the rotator cuff muscles (supraspinatus, infraspinatus, subscapularis and teres minor).</i_keyword>
      <i_keyword>Control group: sham dry needling group: people with shoulder pain who received dry needling in the rotator cuff muscles (supraspinatus, infraspinatus, subscapularis and teres minor) and practically the needle does not enter the skin.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stability of shoulder. Timepoint: Before the intervention, after the end of the treatment  and one week after the end of the treatment as a follow-up. Method of measurement: Closed Kinetic Chain Upper Extremity Stability Test.</prim_outcome>
      <prim_outcome>Upper extremity function. Timepoint: Before the intervention, after the end of the treatment  and one week after the end of the treatment as a follow-up. Method of measurement: Quick Disabilities of Arm, Shoulder &amp; Hand questionnaire.</prim_outcome>
      <prim_outcome>Grip strenght. Timepoint: Before the intervention, after the end of the treatment  and one week after the end of the treatment as a follow-up. Method of measurement: Dynamometer device.</prim_outcome>
      <prim_outcome>Shoulder pain. Timepoint: Before the intervention, after the end of the treatment  and one week after the end of the treatment as a follow-up. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>The strength of internal and external rotators of the shoulder joint. Timepoint: Before the intervention, after the end of the treatment  and one week after the end of the treatment as a follow-up. Method of measurement: Dynamometer 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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-26</approval_date>
        <contact_name>Ethics Committee in Research, Shiraz Faculty of Rehabilitation Sciences</contact_name>
        <contact_address>Abiverdi Street 1, Chamran Blvd Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
