<?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>IRCT20210809052129N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-08</date_registration>
      <primary_sponsor>The University of Faisalabad</primary_sponsor>
      <public_title>Comparison between the effectiveness of laser therapy and graston technique on trigger points of upper trapezius</public_title>
      <acronym></acronym>
      <scientific_title>Comparison between the effectiveness of laser therapy and graston technique on trigger points of upper trapezius</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-07-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58216</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Lottery method was used for subject randomization in groups. Groups names were written on papers and were folded. After that subjects were asked to pick one paper. The groups were allotted to the subjects and then treatment was started, Blinding description: There were three treatment groups in this study. No control group. Groups were allocated to the subjects by the investigator after lottery method but the subjects weren't told which group they belong to. The measurements taken from the participants on questionnaires were also not shown to the participants.</study_design>
      <phase>3</phase>
      <hc_freetext>Myofascial pain syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Graston therapy. Graston tool is used for 1 minute sweeping of upper trapezius, 2 minute swiveling and fanning of Trps then 1 minute swiveling of upper trapezius. After that stretching of muscle with 30 seconds hold in 3 repetitions. Intervention 2: Intervention group 2: Laser therapy. GaAIAs semiconductor laser is used with 808nm wavelength. Myofascial trigger points are marked by drawing an X on them over the skin. With gentle pressure, the laser device is positioned perpendicular to the area of skin to be irradiated and moved in a circular pattern. Each trigger point is irradiated for 60 seconds. After that stretching of muscle with 30 seconds hold in 3 repetitions. Intervention 3: Intervention group 3: Graston and laser therapy. GaAIAs semiconductor laser is used with 808nm wavelength. Myofascial trigger points are marked by drawing an X on them over the skin. With gentle pressure, the laser device is positioned perpendicular to the area of skin to be irradiated and moved in a circular pattern. Each trigger point is irradiated for 60 seconds. After that graston tool is used for 1 minute sweeping of upper trapezius, 2 minute swiveling and fanning of Trps then 1 minute swiveling of upper trapezius. After that stretching of muscle with 30 seconds hold in 3 repetitions.</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 It will be be decided later as per the advice of supervisor and the requirements of the journal in which the article will be sent for publication.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saba Iqbal</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>p# 41, Jail Road Street 1 near Sabqa Board Office Islam Nagar Muhalla, Faisalabad, Punjab</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>37401</zip>
        <telephone>+92 41 2646649</telephone>
        <email>sabaiqbal71263@gmail.com</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saba Iqbal</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jail road, muhalla Islam nagar, St#1, near sabqa board office, Faisalabad, Pakistan</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>37401</zip>
        <telephone>+92 41 2646649</telephone>
        <email>sabaiqbal71263@gmail.com</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Females aged 18 to 50 years old with bilateral myofascial pain syndrome of the upper trapezius muscle.
As stated by Simon’s diagnostic criteria, following sings should be present: Five majors: 1. Pain in a region 2. Pain referring to another area 3. A tight muscle band 4. A tender/painful location in the tight muscle band 5.  Limited ROM.
One minor: 1. Pain that can be regenerated by applying pressure on the location of the tender area 2. A local twitch response in the affected area 3. With prolonged neck and/or shoulder region pain, pain relief that can be achieved with injection or stretching.
Complaint of pain from at least 8 weeks.
Pain score between 30mm to 80mm on VAS.
Neck extension range up to 30 degrees.
Neck right and left side flexion range up to 20 degrees.
NDI score between 10 and 24</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Neck or shoulder pain that has lasted less than 8 weeks
Within the previous three months, local injectable physiotherapy
Infection
Febrile state
Cervical radiculopathy symptoms
Hypertension that has not been treated
Coagulatory disease or anticoagulant therapy
Injury to the cervical spine or surgery
Implants and metal devices</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>MG30.01</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic widespread pain</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Graston therapy. Graston tool is used for 1 minute sweeping of upper trapezius, 2 minute swiveling and fanning of Trps then 1 minute swiveling of upper trapezius. After that stretching of muscle with 30 seconds hold in 3 repetitions.</i_keyword>
      <i_keyword>Intervention group 2: Laser therapy. GaAIAs semiconductor laser is used with 808nm wavelength. Myofascial trigger points are marked by drawing an X on them over the skin. With gentle pressure, the laser device is positioned perpendicular to the area of skin to be irradiated and moved in a circular pattern. Each trigger point is irradiated for 60 seconds. After that stretching of muscle with 30 seconds hold in 3 repetitions.</i_keyword>
      <i_keyword>Intervention group 3: Graston and laser therapy. GaAIAs semiconductor laser is used with 808nm wavelength. Myofascial trigger points are marked by drawing an X on them over the skin. With gentle pressure, the laser device is positioned perpendicular to the area of skin to be irradiated and moved in a circular pattern. Each trigger point is irradiated for 60 seconds. After that graston tool is used for 1 minute sweeping of upper trapezius, 2 minute swiveling and fanning of Trps then 1 minute swiveling of upper trapezius. After that stretching of muscle with 30 seconds hold in 3 repetitions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: before intervention and after 2nd, 5th intervention session and then after 5 days of 5th session. Method of measurement: Pain measurement by visual analogue scale.</prim_outcome>
      <prim_outcome>Neck disability Index. Timepoint: before intervention and after 2nd, 5th intervention session and then after 5 days of 5th session. Method of measurement: Neck functioning measurement by neck disability index.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>(1) Cervical extension ROM. Timepoint: before intervention and after 2nd, 5th intervention session and then after 5 days of 5th session. Method of measurement: Ranges of motion are measured by goniometry.</sec_outcome>
      <sec_outcome>Cervical right lateral flexion ROM. Timepoint: before intervention and after 2nd, 5th intervention session and then after 5 days of 5th session. Method of measurement: Ranges of motion are measured by goniometry.</sec_outcome>
      <sec_outcome>Cervical left lateral flexion ROM. Timepoint: before intervention and after 2nd, 5th intervention session and then after 5 days of 5th session. Method of measurement: Ranges of motion are measured by goniometry.</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>Self financed</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-14</approval_date>
        <contact_name>Ethics committee of The University of Faisalabad</contact_name>
        <contact_address>Sargodha Rd, University Town, Faisalabad, Punjab Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
