<?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>IRCT20210815052194N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-29</date_registration>
      <primary_sponsor>Pro Health Rehab and Medical Center</primary_sponsor>
      <public_title>Effect of stretching in patient with knee osteoarthritis</public_title>
      <acronym></acronym>
      <scientific_title>Comparative Effects of Mulligan Traction Straight Leg Raise Versus Muscle Energy Technique on Pain Intensity and Hamstring Tightness in patient With Knee Osteoarthritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58213</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: The randomization of the participants will be done by using the simple random sampling also called lottery method. Firstly each member of the population is assigned a number. In the next step these numbers are written on separate cards which are physically similar in shape, size, color etc. Then they are placed in a basket and thoroughly mixed. In the last step the slips are taken out randomly without looking at them. The number of slips drawn will be equal to the sample size, Blinding description: Both group Participants will not be aware of the study groups and this will be carried out by keeping the participants anonymous for the study period.</study_design>
      <phase>3</phase>
      <hc_freetext>knee osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group A (Mulligan traction straight leg raise)  treatment will be given to participant's for 4 week, baseline treatment will be moist hot pack and Tens for 10 minutes and than mulligan traction straight leg raise will be applied. Intervention 2: Intervention group: Group B (Muscle energy technique) treatment will be given to participant's for 4 week, baseline treatment will be moist hot pack and Tens for 10 minutes and than muscle energy technique will be applied, 2 sets of 10 repetitions per session. By using 20% of their total strength with hold of 5 second participants will perform isometric contraction and rest for 3-5 seconds between each isometric contraction.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is As we have signed and assured the patient that there data will not be share any where else other than current study</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zain Ali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>P-346 Kashmir Rd, C Block Amin Town, Faisalabad, Punjab, Pakistan.</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 8887668</telephone>
        <email>zainalibal47@gmail.com</email>
        <affiliation>Pro Health Rehab and Medical Center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zain Ali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>P-346 Kashmir Rd, C Block Amin Town, Faisalabad, Punjab, Pakistan.</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 8887668</telephone>
        <email>zainalibal47@gmail.com</email>
        <affiliation>Pro Health Rehab and Medical Center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Both male and female Patients diagnosed with knee osteoarthritis grade 1 and grade 2, with the radiographic evidence as Kellgren-Lawrence criteria of knee osteoarthritis.
Age between 40 to 65years.
Subject shows more than mild pain on VAS.
Patient more than mild disability in OKS.
Unilateral involvement.
Can walk without any assistive device e.g. crutches or walk helplessly.
Patients who was willing to participate.
At least can climb and incline the flight of stairs.
Patient who quit all pain killers and muscle relaxant medication.</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy.
Participant with diagnosed musculoskeletal disorders related to knee joint e.g. femoral-patellar syndrome.
Patients with surgical history of lower limbs/spine.
Patients with pathologies or any deformity of hip joint/spine.
Patient with neurological disorder for example Alzheimer’s disease.
Participants who were refusing to consent.
Participants having unhealed fracture</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M17</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Osteoarthritis of knee</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Group A (Mulligan traction straight leg raise)  treatment will be given to participant's for 4 week, baseline treatment will be moist hot pack and Tens for 10 minutes and than mulligan traction straight leg raise will be applied.</i_keyword>
      <i_keyword>Intervention group: Group B (Muscle energy technique) treatment will be given to participant's for 4 week, baseline treatment will be moist hot pack and Tens for 10 minutes and than muscle energy technique will be applied, 2 sets of 10 repetitions per session. By using 20% of their total strength with hold of 5 second participants will perform isometric contraction and rest for 3-5 seconds between each isometric contraction</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Knee pain intensity. Timepoint: Before intervention, 2 weeks and 4 weeks after intervention. Method of measurement: Visual analogue scale will be used to measure the knee pain intensity.</prim_outcome>
      <prim_outcome>Hamstring tightness. Timepoint: Before intervention, 2 weeks and 4 weeks after intervention. Method of measurement: Goniometer during active knee extension test will used to assess reduction in hamstring tightness.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Oxford knee score questionnaire for disability. Timepoint: before intervention and 4th week. Method of measurement: Oxford knee score will be used for the assessment patients disability.</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>Pro Health Rehab and Medical Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-25</approval_date>
        <contact_name>Ethics and Technical committee of The University of Faisalabad</contact_name>
        <contact_address>University town, Sargodha road, Faisalabad faisalabad punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
