<?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>IRCT2017061634567N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-08-05</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effects of Intramuscular Electrical Stimulation on Upper Trapezius Trigger Points Treatment</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Single Session Intramuscular Electrical Stimulation through Dry Needling on Pain and Dysfunction Following Trigger Points in Upper Trapezius Muscle</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-09-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26385</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study for randomization will be used balanced block randomization.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Trigger Points in Upper Trapezius Muscle.</hc_freetext>
      <i_freetext>Intervention group: The intervention in this group is intramuscular electrical stimulation. The patient is in prone, while the hands are placed next to the body and the head is in the midline. For a patient's comfort, a roll under the forehead is used. The muscle is needled with a pincer palpation. The needle is inserted perpendicular to the skin and directed towards the practitioner’s finger. In the next step, the cathode electrode is connected to the needle and the other is placed by a circular electrode on the spinous process of  seventh vertebra of neck. Then, a burst current (2 Hz frequency, 200µs pulse width)  apply through the needles while electrical current steadily will be increased to meet a pain free contraction.The treatment is continued for a period of ten minutes. &#13;
control(placebo):&#13;
In placebo group procedure is exactly the same but there is no electrical stimulation under dry needling. The treatment is continued for a period of ten 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>monavar hadizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Rehabilitation, Piche Shemiran st, Enghelab Ave, Tehran, Iran</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 7753 3939</telephone>
        <email>hadizadeh-m@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Siamak Bashardoust Tajali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Rehabilitation, Piche Shemiran st, Enghelab Ave, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 2177685105253</telephone>
        <email>s_bashardoust@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>Inclusion criteria:&#13;
1. Active trigger points with specific bundle in upper trapezius muscle&#13;
2. The pain associated with the trigger point of the upper trapezius muscle be higher than 3 based on the VAS scale, which is considered as moderate pain.&#13;
3. Age 18-40&#13;
4. Do not give injections or other treatments for trigger points within a month before the study.&#13;
5. No history of muscle diseases such as fibromyalgia and myopathy.&#13;
6. No malignancy or patients susceptible to infection.&#13;
7. Not having central and peripheral neurological disorders.&#13;
8. Not having radical pain and history of neck surgery.&#13;
9. have no previous history of bad response to acupuncture or dry needling.&#13;
10. No pregnancy&#13;
11. Do not use anticoagulants.&#13;
12. No significant fears from the dry needling.&#13;
13. Not having vascular disease.&#13;
14. Not having diabetes.&#13;
15. Not having a history of migraine.&#13;
exclusion criteria:&#13;
1. Withdrawal of cooperation by the patient.&#13;
2. Discomfort and intolerance method applied to the patient.&#13;
3. Incidence of abnormal reactions during dry needling and treatment.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention in this group is intramuscular electrical stimulation. The patient is in prone, while the hands are placed next to the body and the head is in the midline. For a patient's comfort, a roll under the forehead is used. The muscle is needled with a pincer palpation. The needle is inserted perpendicular to the skin and directed towards the practitioner’s finger. In the next step, the cathode electrode is connected to the needle and the other is placed by a circular electrode on the spinous process of  seventh vertebra of neck. Then, a burst current (2 Hz frequency, 200µs pulse width)  apply through the needles while electrical current steadily will be increased to meet a pain free contraction.The treatment is continued for a period of ten minutes. &#13;
control(placebo):&#13;
In placebo group procedure is exactly the same but there is no electrical stimulation under dry needling. The treatment is continued for a period of ten minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: before application, exactly after treatment and one week after treatment. Method of measurement: by visual analog scale.</prim_outcome>
      <prim_outcome>Pain Pressure Threshold. Timepoint: before application, exactly after treatment and one week after treatment. Method of measurement: by algometer.</prim_outcome>
      <prim_outcome>Range of motion. Timepoint: before application, exactly after treatment and one week after treatment. Method of measurement: by goniometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Disability. Timepoint: before application and week after treatment. Method of measurement: by Neck Disability Index.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-05-03</approval_date>
        <contact_name>Ethics Committee in Tehran University of Medical Sciences</contact_name>
        <contact_address>Tehran, Keshavarz Blvd, Central building of Tehran University of Medical Sciences tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
