<?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>IRCT20200507047328N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-16</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>effect of dry needling versus low-level laser therapy in the treatment of myofascial trigger points</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of dry needling versus low-level laser therapy in the treatment of myofascial trigger points of the upper trapezius muscles of patients referring to physical medicine clinics</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>78</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48009</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: Due to the nature of the intervention and the lack of use of blinding platforms at the level of physician and patient, it cannot be performed.
  Only a person who performs statistical analysis can be kept blind from assigning groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>myofascial trigger points syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: acupuncture. For them, 4 dry needling sessions were performed on the trigger points two days apart. In trapezius muscle treated with dry needling, we mark the points of the muscle that have the most pain as trigger points. For dry needling, special thin needles with a length of 25 mm and a thickness of 0.25 were used. Intervention 2: Intervention group: low-power laser therapy. For them 3 sessions for two weeks, three days each time from the novin device, type LASER 860x, class I type BF 6 joules per square centimeter, average power of 100 MW for each point for 3 minutes done. Intervention 3: Control group: stretching exercises .Control group: Stretching exercises. All patients - including this group - underwent upper trapezius muscle stretching exercises 3 times a day (morning, evening and night), each time for 30 seconds and for two weeks.</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>Mohammadreza Ansari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 6, Roz Complex,32nd alley Negarestan Ave, Kaveh Ave, isfahan city</address>
        <city>isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8196796457</zip>
        <telephone>+98 31 3433 5337</telephone>
        <email>mransari.pmr@resident.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saeid Khosrawi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>physical medicine department of isfahan univecity of medical siences, Hezar jarib St, Isfahan city</address>
        <city>isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174675731</zip>
        <telephone>+98 31 3670 0666</telephone>
        <email>khosrawi@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>patient with diagnosis of myofascial trigger point syndrom of upper trapezius muscle with base of Travel and Simons criteria
age 18 or over
VAS&gt;5
Pain time over one month
Patients tend to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>history of Fx in cervical vertebrae
history of surgical operation in neck, known cervical myelopathy or radiculopathy
history of psychologic or cognitive disorders
opioid abuse and use of corticosteroid oral or IV
active pregnancy
coagulopathy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M79.62</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pain in upper arm</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: acupuncture. For them, 4 dry needling sessions were performed on the trigger points two days apart. In trapezius muscle treated with dry needling, we mark the points of the muscle that have the most pain as trigger points. For dry needling, special thin needles with a length of 25 mm and a thickness of 0.25 were used.</i_keyword>
      <i_keyword>Intervention group: low-power laser therapy. For them 3 sessions for two weeks, three days each time from the novin device, type LASER 860x, class I type BF 6 joules per square centimeter, average power of 100 MW for each point for 3 minutes done</i_keyword>
      <i_keyword>Control group: stretching exercises .Control group: Stretching exercises. All patients - including this group - underwent upper trapezius muscle stretching exercises 3 times a day (morning, evening and night), each time for 30 seconds and for two weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Myofascial trigger point syndrome in the upper trapezius muscle with a VAS score above 5. Timepoint: Patients were evaluated in three periods before and immediately after the intervention and one month after the intervention. Method of measurement: Visual Analogue Scale, Index Neck Disability Index , and Shoulder Pain and Disability Index.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-20</approval_date>
        <contact_name>Ethics committee of isfahan university of medical siences</contact_name>
        <contact_address>ethics committee of isfahan university of medical sciences ,No 4 building, hezar jarib ave, isfahan city isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
