<?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>IRCT2017011426346N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-05-02</date_registration>
      <primary_sponsor>Research Department of Tehran University of Medical Sciences</primary_sponsor>
      <public_title>effect of fatigue on trigger point of upper trapezius muscle</public_title>
      <acronym>Trigger Point (TrP), Upper Trapezius (UT)</acronym>
      <scientific_title>Effect of fatigue on neck joint position sense, pressure pain threshold and pain intensity in trigger point of upper trapezius muscle</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21849</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Neck pain.</hc_freetext>
      <i_freetext>Intervention 1: Fatigue in control group&#13;
subjects were asked to perform a dominant shoulder elevation against the force transducer with as much force as possible for at least 10 sec. This procedure was repeated three times with in-between breaks of 20 s. If the highest force was measured in the last MVC contraction, an additional contraction was performed.&#13;
The maximum number of MVC contractions was limited to three. The highest measured force level was assumed to be the MVC of the trapezius.&#13;
Again the highest force value was considered to be the MVC. After a break of 5 min, a sustained submaximal contraction of the trapezius was performed. The subjects were asked to sustain a unilateral 80% MVC isometric shoulder elevation until the force gauge monitor showed 50% of MVC in least 3 minutes. Intervention 2: Fatigue  in Internationale group &#13;
subjects were asked to perform a dominant shoulder elevation against the force transducer with as much force as possible for at least 10 sec. This procedure was repeated three times with in-between breaks of 20 s. If the highest force was measured in the last MVC contraction, an additional contraction was performed.&#13;
The maximum number of MVC contractions was limited to three. The highest measured force level was assumed to be the MVC of the trapezius.&#13;
Again the highest force value was considered to be the MVC. After a break of 5 min, a sustained submaximal contraction of the trapezius was performed. The subjects were asked to sustain a unilateral 80% MVC isometric shoulder elevation until the force gauge monitor showed 50% of MVC in least 3 minutes.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Gholamreza Olyaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School Of Rehabilitation, Piche Shemroon, Enghelab Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 7752 8469</telephone>
        <email>olyaeigh@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences, School of Rehabilitation</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Gholamreza Olyaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School Of Rehabilitation, Piche Shemroon, Enghelab Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 7752 8469</telephone>
        <email>olyaeigh@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Individuals within an age range of 18 to 35 years will be accepted for both groups to minimize any confounding effects stemming from advanced degenerative alterations in the cervical spine. History of neck pain for a period of more than three months; restricted active or passive neck movement in at least one direction and score range of three to six points on an 11-point (range: 0 to 10)  numerical rating scale for perceived pain intensity. The inclusion criteria for the control group (CG) will be no self-reported history of neck pain and no positive signs of cervical spine or scapular dysfunction during the physical examination.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M79.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Myalgia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Fatigue in control group&#13;
subjects were asked to perform a dominant shoulder elevation against the force transducer with as much force as possible for at least 10 sec. This procedure was repeated three times with in-between breaks of 20 s. If the highest force was measured in the last MVC contraction, an additional contraction was performed.&#13;
The maximum number of MVC contractions was limited to three. The highest measured force level was assumed to be the MVC of the trapezius.&#13;
Again the highest force value was considered to be the MVC. After a break of 5 min, a sustained submaximal contraction of the trapezius was performed. The subjects were asked to sustain a unilateral 80% MVC isometric shoulder elevation until the force gauge monitor showed 50% of MVC in least 3 minutes.</i_keyword>
      <i_keyword>Fatigue  in Internationale group &#13;
subjects were asked to perform a dominant shoulder elevation against the force transducer with as much force as possible for at least 10 sec. This procedure was repeated three times with in-between breaks of 20 s. If the highest force was measured in the last MVC contraction, an additional contraction was performed.&#13;
The maximum number of MVC contractions was limited to three. The highest measured force level was assumed to be the MVC of the trapezius.&#13;
Again the highest force value was considered to be the MVC. After a break of 5 min, a sustained submaximal contraction of the trapezius was performed. The subjects were asked to sustain a unilateral 80% MVC isometric shoulder elevation until the force gauge monitor showed 50% of MVC in least 3 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pressure pain tresold. Timepoint: immediately before and after intervention. Method of measurement: algometer.</prim_outcome>
      <prim_outcome>Pain intensity. Timepoint: immediately before and after intervention. Method of measurement: Visual Analoge Scale.</prim_outcome>
      <prim_outcome>RMS &amp; median frequency. Timepoint: immediately before and after intervention. Method of measurement: surface electromyography.</prim_outcome>
      <prim_outcome>Position sence. Timepoint: immediately before and after intervention. Method of measurement: photography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain. Timepoint: immediatly before and after fatigue. Method of measurement: algometer.</sec_outcome>
      <sec_outcome>Muscle Spasm. Timepoint: immediatly before and after fatigue. Method of measurement: manual assessment.</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>Research Department of Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-10-22</approval_date>
        <contact_name>Ethic Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>ehran University of Medical Sciences, Pour Sina St, Keshavarz blvd. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
