<?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>IRCT20151007024412N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-27</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Thickness changes in myofascial pain syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Effects of positional release and passive shortening techniques on pain and muscle thickness in people with latent trigger points</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>42</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59985</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is performed by someone outside the research team using the 1: 1 parallel allocation method. A computer randomization program is used to assign participants to groups, using blocks of four and six. Matte sealed envelopes are then used and concealment is done by assigning groups using the pre-labeled letters A and B, Blinding description: The study will done in a blind way and the evaluator does not know which group each person is in. First, preliminary evaluations including muscle thickness, PPT and VAS are performed by the examiner. After the evaluations are completed, therapeutic techniques are applied based on the group that each person is randomly placed in, by another person (therapist) and without the knowledge of the evaluating person (examiner). Immediately after the completion of the technique, the evaluations will be done again by the examiner.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Myofascial pain syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Manual Passive Muscle Shortening technique: The person sleeps on his back and a pillow is placed under his abdomen. The therapist stands on the involved side and brings the beginning and end of the involved upper trapezius muscle (the periphery of the sixth cervical vertebra and the acromion appendage) closer together using the web of his hands and shortens the muscle. This position is maintained for 90 seconds and finally the muscle is slowly released and returns to its original position. These steps are repeated three times. Intervention 2: Control group: Positional release. The patient sleeps on the vault and the therapist stands on the involved side. Then with his finger, he applies some pressure on the trigger point that has the most pain (A) and asks the person to keep in mind the amount of pain caused by this pressure. The person's head bends towards the trigger point. Then the therapist takes the person's hand and takes the person's shoulder to about 90 degrees of abduction and slowly moves the hand in different planes in search of the ideal position. After finding the ideal position (minimum 70% reduction of pain at the desired point), while the therapist's finger is placed on the painful point without pressure, the person's hand and shoulder are kept in that position for 90 seconds. Finally, the person's body is passively returned to its original state and these steps are repeated three 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Although the data is non-identifying of the participants, only the statistical results obtained from the data are published, and they are not published in order to prevent other people from copying and creating data.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sakineh Goljaryan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz University. Faculty of Rehabilitation Sciences.29 Bahman Street.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166616471</zip>
        <telephone>+98 41 3337 5359</telephone>
        <email>goljaryan@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sakineh Goljaryan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz University of Medical Sciences, Golgasht Street, University Street, Tabriz.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166616471</zip>
        <telephone>+98 41 3335 5921</telephone>
        <email>goljaryan@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Minimum age 18 and maximum 35
The presence of a latent trigger point in the right or left upper trapezius muscle (if both sides are involved, the selection will be random)
Having a minimum pain of 3 and a maximum of 7 on the visual scale of pain during the application of force 2.5 kg / cm2 by the algometer
BMI between 20-25
Being a non-athlete</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Having a history of radiculopathy or myelopathy of the neck with the diagnosis of a specialist
Fibromyalgia syndrome diagnosed by a specialist doctor
History of neck and shoulder surgery during the past year
Trigger point treatment in the last month
Existence of sensory disturbance in trapezoidal area
Having a history of Whiplash injury
Acute upper trapezius muscle injury in the last 6 days</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M62.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disorder of muscle, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Manual Passive Muscle Shortening technique: The person sleeps on his back and a pillow is placed under his abdomen. The therapist stands on the involved side and brings the beginning and end of the involved upper trapezius muscle (the periphery of the sixth cervical vertebra and the acromion appendage) closer together using the web of his hands and shortens the muscle. This position is maintained for 90 seconds and finally the muscle is slowly released and returns to its original position. These steps are repeated three times.</i_keyword>
      <i_keyword>Control group: Positional release. The patient sleeps on the vault and the therapist stands on the involved side. Then with his finger, he applies some pressure on the trigger point that has the most pain (A) and asks the person to keep in mind the amount of pain caused by this pressure. The person's head bends towards the trigger point. Then the therapist takes the person's hand and takes the person's shoulder to about 90 degrees of abduction and slowly moves the hand in different planes in search of the ideal position. After finding the ideal position (minimum 70% reduction of pain at the desired point), while the therapist's finger is placed on the painful point without pressure, the person's hand and shoulder are kept in that position for 90 seconds. Finally, the person's body is passively returned to its original state and these steps are repeated three times.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Thickness of the upper trapezius muscle. Timepoint: Before the start of the intervention, immediately after the intervention, 2 days after the first session, 9 days after the first session. Method of measurement: sonography.</prim_outcome>
      <prim_outcome>Pain. Timepoint: Before the start of the intervention, immediately after the intervention, 2 days after the first session, 9 days after the first session. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Pain pressure threshold. Timepoint: Before the start of the intervention, immediately after the intervention, 2 days after the first session, 9 days after the first session. Method of measurement: pressure algometry.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-08-29</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>29 Bahman street - Tabriz University - Faculty of Rehabilitation Sciences Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
