<?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>IRCT20240403061406N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-09-23</date_registration>
      <primary_sponsor>The University of Faisalabad</primary_sponsor>
      <public_title>Graston technique vs direct myofascial  release in upper trapezius trigger points</public_title>
      <acronym></acronym>
      <scientific_title>Graston technique vs Direct Myofascial  Release: A comparative study for  alleviating symptoms of upper trapezius trigger points among visual display terminal users</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/78691</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization was done using the lottery method using simple randomization technique to make sure that participants were assigned to the study groups in an unbiased and random manner. patients were allocated by chit &amp; draw method wherein individuals were given sealed envelops. all with alphabet A were allocated to Graston technique group &amp; all with Alphabet B to direct myofascial release group and with alphabet C to control group. allocation concealment was done and patients were given different time of the day on different alternate days to avoid any discussion between them.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Primary disorders of muscles.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: direct myofascial release technique.The direct myofascial release technique is a hands-on physiotherapy manual technique that aims to release tension and improve mobility in the affected muscles by applying sustained pressure.The technique will be applied to the affected side of the trapezius muscle each session of myofascial release will be applied for 3 to 4 minutes.The intervention will be administered thrice a week for 4 weeks. no additional devices or tools will be used other than the practitioner's hands. Intervention 2: Intervention group 2: graston technique, an instrument-assisted soft tissue mobilization tool.The graston technique involves using a specially designed stainless-steel instrument to detect and treat areas of muscle tightness, scar tissue, and adhesions. the tool is used to apply controlled pressure and strokes to the affected tissue. The technique will be applied to the affected side of the trapezius muscle. each session of graston treatment will be applied for 3 to 4 minutes.The intervention will be administered thrice a week for 4 weeks.graston tool stainles steel instrument. Intervention 3: Control group 3: participants in this group received only the baseline treatment, which consisted of therapeutic ultrasound using the enraf-nonius souls 190 device. the ultrasound was applied in continuous mode for seven minutes at a frequency of 1 MHz and an intensity of 1.5 watt/cm². this treatment was administered three times a week for a total duration of four weeks.Following the completion of the treatment protocol, post-treatment readings were taken using standardized outcome measures to assess the effectiveness of the intervention.</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 not decided yet</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mariam Mehmood</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Canal Road Amin Campus</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>380000</zip>
        <telephone>+92 301 4223896</telephone>
        <email>mariam.mehmood@tuf.edu.pk</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mariam Mehmood</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Canal Road Amin Campus</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>380000</zip>
        <telephone>+92 301 4223896</telephone>
        <email>mariam.mehmood@tuf.edu.pk</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Neck pain (upper traps)
Musculoskeletal strain (upper trapezius) symptoms for more than 3 months
Both males and females
Asthenopia
Dry eyes
Visual blurring
Exclusive mobile and laptop users. 4 to 5 hours per day and five to six days
History of consecutive near-screen exposure from the past 8 weeks
Participants complaining of pain of ≥ 3 on NPRS (moderate)
A full passive range of cervical flexion/extension, rotation, and lateral flexion
Age between 18 and 35 year
A 20° to 30° loss of active neck flexion/extension with loss of cervical rotation of 20°   to 40° to both sides and a 10° to 15° loss of lateral flexion</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who have a history of trauma affecting mainly the neck
Any radiating pain or prolapsed intervertebral disc-related neurological symptoms
Patients with co-morbidities other chronic Neck pain and Trapezius trigger points and tightness
Osteoporosis/ osteoarthritis
Cervical spondylosis/spondylolisthesis
Asymptomatic trigger points</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G71</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Primary disorders of muscles</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: direct myofascial release technique.The direct myofascial release technique is a hands-on physiotherapy manual technique that aims to release tension and improve mobility in the affected muscles by applying sustained pressure.The technique will be applied to the affected side of the trapezius muscle each session of myofascial release will be applied for 3 to 4 minutes.The intervention will be administered thrice a week for 4 weeks. no additional devices or tools will be used other than the practitioner's hands.</i_keyword>
      <i_keyword>Intervention group 2: graston technique, an instrument-assisted soft tissue mobilization tool.The graston technique involves using a specially designed stainless-steel instrument to detect and treat areas of muscle tightness, scar tissue, and adhesions. the tool is used to apply controlled pressure and strokes to the affected tissue. The technique will be applied to the affected side of the trapezius muscle. each session of graston treatment will be applied for 3 to 4 minutes.The intervention will be administered thrice a week for 4 weeks.graston tool stainles steel instrument.</i_keyword>
      <i_keyword>Control group 3: participants in this group received only the baseline treatment, which consisted of therapeutic ultrasound using the enraf-nonius souls 190 device. the ultrasound was applied in continuous mode for seven minutes at a frequency of 1 MHz and an intensity of 1.5 watt/cm². this treatment was administered three times a week for a total duration of four weeks.Following the completion of the treatment protocol, post-treatment readings were taken using standardized outcome measures to assess the effectiveness of the intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain calculated through numeric pain rating scale. Timepoint: pain is measured before intervention at 2nd week of intervention and at 4th week. Method of measurement: pain measurement through numeric pain rating scale.</prim_outcome>
      <prim_outcome>Range of motion. Timepoint: range of motion is measured before intervention at 2nd week of intervention and at 4th week. Method of measurement: range of motion is measured through goniometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Muscle flexibility. Timepoint: muscle flexibility is measured before intervention at 2nd week and at 4th week. Method of measurement: muscle flexibility is measured through goniometer.</sec_outcome>
      <sec_outcome>Work performance. Timepoint: work performance is measured before intervention at 2nd week and at 4th week. Method of measurement: work performance is measured through ocular surface index questionnaire.</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>The University of Faisalabad</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-01-05</approval_date>
        <contact_name>Ethics Committee of The University of Faisalabad</contact_name>
        <contact_address>Canal Road Amin Campus Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
