<?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>IRCT20190413043266N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-07-01</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The Effects of Laser Acupuncture</public_title>
      <acronym></acronym>
      <scientific_title>The Effects of Laser Acupuncture on Myofascial Pain Syndrome-a Randomised Controlled Trial on Female Subjects</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2009-08-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/39015</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Other, Randomization description: The participants were randomly allocated to two groups of 30 using a table of random numbers, Blinding description: The physiotherapist, who was unaware of patient groupings, completed a questionnaire. He then assessed patients.
The another physiotherapist performed 10 laser therapy sessions for the treatment groups with the laser.  
The same procedure was followed in the control group while the laser system was off. Similar conditions were considered for both groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Myofacial Pain Symdrome.</hc_freetext>
      <i_freetext>Intervention 1: Treatment group: Low-level laser (830 nm, 1.5 J, 30 mw) was applied on 13 Aqupuncture points (C7and SI3, LU7, GB21, GB34, GB39, UB10 bilaterally) with contact way.  This group received exercise therapy. The sessions were held every other day and lasted for 15 minutes. An Enraf-Nonius Endolaser 476 (the Netherland) with 100% continuous output and vertical contact was used. Intervention 2: Control group: off laser aqupuncture received with contact way same point with treatment group. This group received exercise therapy. The sessions were held every other day and lasted for 15 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
eshterak

When:
no

To whom:
no

Conditions:
no

Where to obtain:
no

How to obtain:
no

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sayed Mohsen Mirbod</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Esfahan university, hezar jrib Ave</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۱۷۴۶۷۳۴۶۱</zip>
        <telephone>+98 31 3792 5000</telephone>
        <email>mirbod@rehab.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sayed Mohsen Mirbod</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Esfahan university, hezar jrib Ave</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۱۷۴۶۷۳۴۶۱</zip>
        <telephone>+98 31 3792 5000</telephone>
        <email>mirbod@rehab.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients were only included if they had all or most well-identified symptoms of MPS in the neck. According to reliable rheumatology resources, these symptoms include pain, spasms, sensitivity to stress, active trigger point, joint stiffness, muscle weakness, and motor limitation
In addition, the presence of active trigger points in the trapezius (upper fibers) was another necessity for entering the study</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Patients were excluded if they had symptoms of fibromyalgia in physical examination
Subjects with history of herniated discs, fractured neck or cervical vertebrae, surgery, radiculopathy, and myelopathy were also excluded
Moreover, individuals who had taken non-steroidal anti-inflammatory drugs or pain killers during the two-week period prior to treatment were not included</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M00-M99</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diseases of the musculoskeletal system and connective tissue</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Treatment group: Low-level laser (830 nm, 1.5 J, 30 mw) was applied on 13 Aqupuncture points (C7and SI3, LU7, GB21, GB34, GB39, UB10 bilaterally) with contact way.  This group received exercise therapy. The sessions were held every other day and lasted for 15 minutes. An Enraf-Nonius Endolaser 476 (the Netherland) with 100% continuous output and vertical contact was used.</i_keyword>
      <i_keyword>Control group: off laser aqupuncture received with contact way same point with treatment group. This group received exercise therapy. The sessions were held every other day and lasted for 15 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity during rest and exercise. Timepoint: Baseline, the 5th and 10th sessions, and one month after the treatment. Method of measurement: In order to measure pain intensity, the patients were asked to mark their pain during rest and exercise on a 10-cm linear visual analogue scale (VAS).</prim_outcome>
      <prim_outcome>The range of motion. Timepoint: Baseline, the 5th and 10th sessions, and one month after the treatment. Method of measurement: The active range of motion of the neck using a goniometer.</prim_outcome>
      <prim_outcome>Pressure sensitivity. Timepoint: Baseline, the 5th and 10th sessions, and one month after the treatment. Method of measurement: Pressure sensitivity was assessed using a mechanical pressure algometer.</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>2009-08-16</approval_date>
        <contact_name>Ethics Committee of Esfahan University of Medical Sciences</contact_name>
        <contact_address>Esabne Maryam Hospital Shamsabadi Ave Esfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
