<?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>IRCT20220510054804N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-07-30</date_registration>
      <primary_sponsor>Faisal Institute of Health Sciences</primary_sponsor>
      <public_title>Comparative Study on the Effects Of Low Level Laser Therapy and Ultrasound Therapy in Sportsmen with ACL Reconstructive Surgery</public_title>
      <acronym>ACL( ANTERIOR CRUICIATE LIGAMNET)</acronym>
      <scientific_title>Comparative Study on the Effects Of Low Level Laser Therapy and Ultrasound Therapy in Sportsmen with ACL Reconstructive Surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-03-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>34</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63609</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Non-probability purposive sampling technique will be utilized for collecting sample and sample will be allocated to treatment group A and B by using online randomization generator. 2 sets of 17 unique numbers per set Range: From 1 to 34— Sorted from Least to Greatest Group A: Low Level Laser Therapy [1,2,6,7,10,11,15,17,18,19,20,22,23,24,29,32,33] Group B: Ultrasonic Therapy[3,4,5,8,9,12,13,14,16,21,25,26,27,28,30,31,32,34].</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>ACL ( Anterior Cruciate Ligament ) injury is a tear or sprain of the anterior cruciate ligament — one of the strong bands of tissue that help connect your thigh bone (femur) to your shinbone (tibia) which is then reconstructed surgically..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 1. After giving participants the base line treatment. Group 1 will receive low level laser therapy of wavelength 810 nm, frequency with continuous output, spot size of 0.0364cm2, energy per point upto 6 J, and  number of irradiation points are 6. Low level laser therapy at each point will be applied for 30 seconds. Readings will be noted at the end of each week for four weeks and results will be drawn. Intervention 2: Intervention group: 2. After giving participants the base line treatment. Group 2 will receive ultrasonic therapy. And the power ultrasound device with a sound head area of 5 cm2 and frequency of the device is 1-MHz, effective radiating area is 3.5–5 cm2 and ultrasonic therapy will be implemented for 5 minutes on each participant. Readings will be noted at the end of each week for four weeks and results will be drawn.</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 is not yet known if there will be a plan to make this available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Ramesha Tahir; PT</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>C483+95F, Block A People's Colony No 1, Faisalabad, Punjab</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 8536999</telephone>
        <email>fihsfsd@outlook.com</email>
        <affiliation>Faisal Institute of Health Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Ramesha Tahir; PT</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>C483+95F, Block A People's Colony No 1, Faisalabad, Punjab</address>
        <city>FAISALABAD</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 8536999</telephone>
        <email>fihsfsd@outlook.com</email>
        <affiliation>Faisal Institute of Health Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Sportsman of age ranging from 18-35 years old plying for the past 3-5 years having ACL reconstructive surgery.
Patient scoring pain on NPRS at least 3
Those who were active in their respective sports and has recent ACL injury
Minimum 7 days post-operative ACL reconstructive sportsman after opening of stitches
Both genders are included</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Athletes having any surgery such as fractures, dislocation
Sportsman suffering from any previous trauma for the past 6 months
Person having DVT (deep vein thrombosis)
Contraindications of Mobilization ( Hypermobility, Joint Effusion and Inflammation)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S83. 512A</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Code S83. 512A is the diagnosis code used for Sprain of anterior cruciate ligament of left knee. A condition leads to anterior dislocation of knee joint ( Femur and Tibia ). Thus patient is unable to walk because of extreme pain.</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 1. After giving participants the base line treatment. Group 1 will receive low level laser therapy of wavelength 810 nm, frequency with continuous output, spot size of 0.0364cm2, energy per point upto 6 J, and  number of irradiation points are 6. Low level laser therapy at each point will be applied for 30 seconds. Readings will be noted at the end of each week for four weeks and results will be drawn.</i_keyword>
      <i_keyword>Intervention group: 2. After giving participants the base line treatment. Group 2 will receive ultrasonic therapy. And the power ultrasound device with a sound head area of 5 cm2 and frequency of the device is 1-MHz, effective radiating area is 3.5–5 cm2 and ultrasonic therapy will be implemented for 5 minutes on each participant. Readings will be noted at the end of each week for four weeks and results will be drawn.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The numerical pain rating scale was utilized to measure intensity of pain. Pain Intensity was rated on 0-10 scale at a horizontal bar. NPRS consists of 11 points, which range from 0= no pain, 1-4= mild pain, 4-7= moderate pain 7-10= severe pain. Timepoint: 5 timepoints including Baseline, 1st week post treatment, 2nd week post treatment, 3rd week post treatment, 4th week post treatment. Method of measurement: Numerical Pain Rating Scale will be utilized to assess pain.</prim_outcome>
      <prim_outcome>Universal Goniometer will be used to measure Knee ROM. Timepoint: 5 timepoints including Baseline, 1st week post treatment, 2nd week post treatment, 3rd week post treatment, 4th week post treatment. Method of measurement: Universal Goniometer will be used to measure Knee ROM.</prim_outcome>
      <prim_outcome>Cincinnati Knee Rating System will be used to measure improved functionality of Knee. Timepoint: 5 timepoints including Baseline, 1st week post treatment, 2nd week post treatment, 3rd week post treatment, 4th week post treatment. Method of measurement: Cincinnati Knee Rating System will be used to measure improved functionality of Knee.</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>Self Financed</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-03-10</approval_date>
        <contact_name>Ethics committee of Government College University Faisalabad</contact_name>
        <contact_address>C389+CXH, Kotwali Rd, Gurunanakpura, Faisalabad, Punjab Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
