<?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>IRCT20181216042008N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-10</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Upper trapezius muscle elastogeraphy in neck pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the immediate effect of passive static stretching and post isometric relaxation techniques on the pain and  upper trapezius muscle stiffness in people with chronic nonspecific neck pain using sonoelastography</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46165</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For an equal number of samples in both groups, randomization is a block randomization method. The tool used in this method is "Random allocation software". In this software; the random sequence is determined by specifying the number of groups(2 groups), the type of groups (intervention and control), and the sample size, Blinding description: Participants will not be aware of the allocation of study groups. Also, the sonography specialist, as an outcome assessor, will not be aware of the type of interventions and grouping of participants.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic non-specific neck pain.</hc_freetext>
      <i_freetext>Intervention 1: Control group: The subject sits on a chair and the physiotherapist stands behind it.The physiotherapist asks the subject to hold the edge of the chair to prevent from ipsilateral shoulder moving.Then, subject's neck is bends to forward and sideways slowly in a pain-free range of movement and rotate to opposite side by physiotherapist.This condition is maintained for 60 seconds and will be repeated 3 times. The break between repetitions is 30 seconds. Intervention 2: Intervention group: The subject sits on a chair and the physiotherapist stands behind it.The physiotherapist asks the subject to hold the edge of the chair to prevent from ipsilateral shoulder moving.Then, subject's neck is bends to forward and sideways slowly in a pain-free range of movement and rotate to opposite side by physiotherapist. Next, The subject is asked to bend his or her head toward the involved side. While performing this exercise, the physiotherapist applies a small amount of resistance to his or her head and this resistance is maintained for 10 seconds. Then rest. Rest time is 30 seconds. This manual treatment will be repeated 3 times.</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>Gholam-hossein Nassadj</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Physiotherapy Department, Rehabilitation School, Ahvaz Jundishapur University of Medical Sciences, Golestan Highway</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135733133</zip>
        <telephone>+98 61 3374 3101</telephone>
        <email>nassadj@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Khadijeh Kazemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Physiotherapy Department, Rehabilitation School, Ahvaz Jundishapur University of Medical Sciences, Golestan Highway</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135733133</zip>
        <telephone>+98 61 3374 3101</telephone>
        <email>kh.kazemi63@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Discomfort sense in upper trapezius muscle
Neck pain for the  three months ago
Neck disability questionnaire score more than five</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Neurological and traumatic disorders
Upper trapezius muscle open wound
Shoulder joint disorder
Shoulder and neck surgery
Taking muscle relaxant drugs and rehabilitation therapy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G89.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic pain syndrome</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: The subject sits on a chair and the physiotherapist stands behind it.The physiotherapist asks the subject to hold the edge of the chair to prevent from ipsilateral shoulder moving.Then, subject's neck is bends to forward and sideways slowly in a pain-free range of movement and rotate to opposite side by physiotherapist.This condition is maintained for 60 seconds and will be repeated 3 times. The break between repetitions is 30 seconds.</i_keyword>
      <i_keyword>Intervention group: The subject sits on a chair and the physiotherapist stands behind it.The physiotherapist asks the subject to hold the edge of the chair to prevent from ipsilateral shoulder moving.Then, subject's neck is bends to forward and sideways slowly in a pain-free range of movement and rotate to opposite side by physiotherapist. Next, The subject is asked to bend his or her head toward the involved side. While performing this exercise, the physiotherapist applies a small amount of resistance to his or her head and this resistance is maintained for 10 seconds. Then rest. Rest time is 30 seconds. This manual treatment will be repeated 3 times.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Upper trapezius stiffness. Timepoint: Before and immediately after treatment. Method of measurement: By Elastography Mode of sonography device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain. Timepoint: Before and immediately after treatment. Method of measurement: Using Visual analog scale(VAS).</sec_outcome>
      <sec_outcome>Functional diasbility. Timepoint: Before and immediately after treatment. Method of measurement: By Neck disability index(NDI) questionnaire.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-09-26</approval_date>
        <contact_name>Ethics committee of Ahvaz Jundishaur University of Medical Science</contact_name>
        <contact_address>physiotherapy department, Rehabilitation school, Ahvaz jundishapur university of medical sciences, Golestan highway Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
