<?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>IRCT20220401054385N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-06-05</date_registration>
      <primary_sponsor>The University of Faisalabad</primary_sponsor>
      <public_title>Effect of Patellofemoral Joint Mobilizations for knee pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparative effect of Functional Patellofemoral Joint Mobilizations and Open-Pack Patellofemoral Joint Mobilization for Patellofemoral Pain Syndrome; A Randomized Clinical Trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62700</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: Sample will be allocated to Group A (Functional mobilization) and Group B (Open pack mobilization) randomly using coin tossing.
Method of randomization: Simple randomization
Tool for randomization: Sealed envelopes
Unit of randomization: Individual
Allocation will be concealed from the participants, they will not know whether they are in the treatment or control group,, Blinding description: Participants of both groups will be unaware whether they are in active control group or the treatment group after taking informed consent from them. Participants of both groups will receive the same baseline treatment that is quadriceps strengthening exercises. After that Physiotherapist will apply different types of knee mobilizations to both groups of which the participants will be unaware of.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patellofemoral pain syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group (Group A) ; 1.	Hot pack (10 min) 2.Grade 1-11 Functional patellofemoral joint mobilizations 3.Baseline Quadriceps strengthening exercise program. Intervention 2: Control group: Hot pack (10 min) 2.Grade 1-11open-pack patellofemoral joint mobilizations 3.Baseline Quadriceps strengthening exercise program.</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:
All collected deindentified participant data set for the outcome measures.

When:
4 months after publication

To whom:
People working in the academic institutions

Conditions:
IPD and any any additional supporting documents will be provided for the research on the similar topic and can be obtained by asking through the contact person mentioned below

Where to obtain:
Contact person: Laiba Nadeem
contact no: 0308 6511400
email:laiba_nadeem1708@gmail.com

How to obtain:
Data files will be provided after talking to the contact person as mention in the above slot.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Sidra Majeed,PT</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>4-km Sargodha road, University town, Faisalabad, Pakistan</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 334 7731241</telephone>
        <email>sidra.majeed@tuf.edu.pk</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Laiba Nadeem</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House no 12,sahil homes, mian zulfiqar ali shahid road, Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 308 6511400</telephone>
        <email>dpt-fa14-097@tuf.edu.pk</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients at the age of 18-35 years old
Both gender
Willingness to participate in the research
Willingness for random allocation to either of the two groups
Pain in the knee associated with, during or after the activity including stair ascending/descending, squatting, jumping, prolonged sitting etc
Insidious onset of pain that is unrelated to trauma
Patient having at least one positive test from these physical tests: 1)Patellofemoral grind test. 2) Patellar apprehension test.3) Step down test
Visual analogue scale rating of anterior knee pain during daily activities at a minimum of 30 mm to 70 mm on 100 mm scale</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Meniscal injury or any other articular injury.
Knee ligament laxity.
History of recent knee surgery 
History of recent patellar dislocation
NSAID or corticosteriod drug use before testing within 24 hours</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M22.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Patellofemoral disorders</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 (Group A) ; 1.	Hot pack (10 min) 2.Grade 1-11 Functional patellofemoral joint mobilizations 3.Baseline Quadriceps strengthening exercise program.</i_keyword>
      <i_keyword>Control group: Hot pack (10 min) 2.Grade 1-11open-pack patellofemoral joint mobilizations 3.Baseline Quadriceps strengthening exercise program.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain in the anterior knee. Timepoint: Pain level will be measured before applying the intervention and then after 4 weeks after the completion of intervention. Method of measurement: Visual Analogue scale and anterior knee pain scale will be used to measure the pain.</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>The University of Faisalabad</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-07</approval_date>
        <contact_name>Ethics committee of The University of Faisalabad</contact_name>
        <contact_address>4-km,Sargodha Road, University Town, Faisalabad, Pakistan. Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
