<?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>IRCT20180602039945N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-03-17</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>effect of Manual pressure release and Algometer pressure release on morphological characteristics in  upper trapezius muscle with latent trigger points</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of Manual pressure release and Algometer pressure release on morphological characteristics in latent upper trapezius muscle trigger points</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-06-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34395</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple random randomization method with random number table is performed, Blinding description: After fully explaining the study process to the participants and informed consent by the patient ، no information was given on the type of treatment and the specificities of intervention groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>latent trigger points.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group:manual pressure release.It is a popular, safe and effective treatment method that is carried out by a skilled physiotherapist.It is continuous manual pressure with tolerable pain that is apply with fingertip or thumb over the tissue barrier at the trigger point. Intervention 2: Second intervention group: pressure release with algometer.It is continuous pressure with tolerable pain that is carried out by the therapist that mechanical therapeutic algometer is used for apply continuous and effective pressure and maintain pressure by therapist.</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:
Only part of the data, such as the information on the main outcome or the like, can be shared

When:
Start the access period immediately after printing the results

To whom:
Researchers working in academic and academic institutions

Conditions:
No bets

Where to obtain:
To the e-mail address:Rahimehfazeli@smbu.ac.ir

How to obtain:
Unlimited

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rahimeh Fazeli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kayanshahr, Salimi St., No. 11</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1858777796</zip>
        <telephone>+98 21 7631 6820</telephone>
        <email>rahimehfazeli@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sedighe Sadat Naimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Damavand Avenue, Opposite of Bouali Hospital, Faculty of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1616913111</zip>
        <telephone>+98 21 7754 8496</telephone>
        <email>Naimi_Se@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women with age ranges from 20 to 40 years
presence of latent trigger points in the muscle based on the therapist's assessment
presence of palpable taut bundles in skeletal muscle
presence of at least 1 tender point in taut bundle in response to the pressure of 25 Newtons per square meter by the therapist
Creation of pain at least 3 of 10 in visual scale of pain in Initial assessment</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Diagnosis of fibromyalgia syndrome
History of severe head and neck injury and whiplash injury
History of cervical spine surgery and fracture and hypermobility or instability
Diagnosis of radiculopathy, myelopathy and malignancy
Treating the trigger points in a past month
If patients are not willing to continue to work for any reason</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M79.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Soft tissue disorder, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group:manual pressure release.It is a popular, safe and effective treatment method that is carried out by a skilled physiotherapist.It is continuous manual pressure with tolerable pain that is apply with fingertip or thumb over the tissue barrier at the trigger point.</i_keyword>
      <i_keyword>Second intervention group: pressure release with algometer.It is continuous pressure with tolerable pain that is carried out by the therapist that mechanical therapeutic algometer is used for apply continuous and effective pressure and maintain pressure by therapist.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity based on the visual analogue scale. Timepoint: Before intervention; immediately after intervention; fifth session; 15 days after the last session. Method of measurement: Visual analogue pain.</prim_outcome>
      <prim_outcome>Pressure pain threshold. Timepoint: Before intervention; immediately after intervention; fifth session; 15 days after the last session. Method of measurement: With algometer device.</prim_outcome>
      <prim_outcome>Neck lateral flexion range of motion. Timepoint: Before intervention; immediately after intervention; fifth session; 15 days after the last session. Method of measurement: With goniometer device.</prim_outcome>
      <prim_outcome>Thickness of upper trapezius muscle. Timepoint: Before intervention;fifth session; 15 days after the last session. Method of measurement: With the help of ultrasonography and measuring the vertical distance between two fascias.</prim_outcome>
      <prim_outcome>Histogram of upper trapezius muscle. Timepoint: Before intervention;fifth session; 15 days after the last session. Method of measurement: With the help of ultrasonography and measure the mean light.</prim_outcome>
      <prim_outcome>P angle in upper trapezius muscle fibers. Timepoint: Before intervention;fifth session; 15 days after the last session. Method of measurement: With the help of ultrasonography and measuring the angle of the fibers.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Before the intervention; fifth session. Method of measurement: Quality of life questionnaire with 36 items.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-12-18</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Kianshahr Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
