<?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>IRCT20190411043241N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-09-02</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Use of laser beams on postneedling soreness and treatment of chronic cervical pain</public_title>
      <acronym></acronym>
      <scientific_title>Short Term Effects of Low versus High Power Lasers on Soreness following Dry Needling at Neck Myofascial Pain Syndrome induced by Active Trigger Points of Upper Trapezius Muscle.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-06-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38815</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Balanced Block Randomizatin, Blinding description: Using laser off in the placebo group will cause blindness to the participants. Assessor will not be aware about patient's group, because assessment will do in another room.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Active Trigger Points in Upper Trapezius Muscle.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: High Power Laser: In this group, the dry needle is applied to the most active trigger point in the upper trapezius muscle. Immediately a laser with a power of 1 watts / cm2 is applied for 6 seconds and with a total energy of 6 joules . Intervention 2: Intervention group: Low Power Laser: In this group, the dry needle is applied to the most active trigger point in the upper trapezius muscle. Immediately a laser with a power of 100 miliwatts / cm2 is applied for 60 seconds and with a total energy of 6 joules . Intervention 3: Control group: Sham Laser: In this group  the dry needle is applied to the most active trigger point in the upper trapezius muscle. Immediately the off laser probe will be use at the point for 1 minute .</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 There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Motavalian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Physiotherapy,School of rehabilitation,Pitch-e shemirn, Enghelab avenue</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>111551683</zip>
        <telephone>+98 21 7753 3939</telephone>
        <email>m-motavalian@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>Department of Physiotherapy,School of rehabilitation,Pitch-e shemirn, Enghelab Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>111551683</zip>
        <telephone>+98 21 7753 3939</telephone>
        <email>S_Bashardoust@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Females aged 18-35 years old
Cervical pain lasting for 3 months or more
Neck pain intensity of at least 3 points based on the VAS scale
Presence of a palpable taut band in the muscle
Presence of a hypersensitive tender spot in the taut band
Local or referred pain elicitation in response to compression</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Contraindications of dry needling(cancer, presence of coagulation  and vascular disorders, Pregnancy, epilepsy,  fibromyalgia, needle aversion or phobia)
Significant psychological disorders
Stress in the last week
Cervical radiculopathy pain
Dizziness
History of cervical surgery</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 - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: High Power Laser: In this group, the dry needle is applied to the most active trigger point in the upper trapezius muscle. Immediately a laser with a power of 1 watts / cm2 is applied for 6 seconds and with a total energy of 6 joules .</i_keyword>
      <i_keyword>Intervention group: Low Power Laser: In this group, the dry needle is applied to the most active trigger point in the upper trapezius muscle. Immediately a laser with a power of 100 miliwatts / cm2 is applied for 60 seconds and with a total energy of 6 joules .</i_keyword>
      <i_keyword>Control group: Sham Laser: In this group  the dry needle is applied to the most active trigger point in the upper trapezius muscle. Immediately the off laser probe will be use at the point for 1 minute .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain of palpation. Timepoint: Before  intervention, immediately after, 24 and 48 hours after intervention. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Pain Pressure Threshold. Timepoint: Before  intervention, immediately after, 24 and 48 hours after intervention. Method of measurement: By using algometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>General pain. Timepoint: Before  intervention, immediately after, 24 and 48 hours after intervention. Method of measurement: Visual Analogue Scale.</sec_outcome>
      <sec_outcome>Cervical range of motion. Timepoint: Before  intervention, immediately after and 48 hours after intervention. Method of measurement: By using a goniometer.</sec_outcome>
      <sec_outcome>Neck disability. Timepoint: Before  intervention and 48 hours after intervention. Method of measurement: 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>2019-06-25</approval_date>
        <contact_name>Ethics committee of nursing and midwifery and rehabilitation schools of Tehran University of Medical</contact_name>
        <contact_address>Ghods Ave , Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
