<?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>IRCT201702222793N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-06-27</date_registration>
      <primary_sponsor>Vice chancellor for research of Ahvaz Jundishapur University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of an etiologic-based exercise and conventional exercises on knee loading in individuals with Knee osteoarthritis.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of effectiveness of an etiologic-based exercise and conventional  exercises on knee loading, pain and functional activity in individuals with Knee osteoarthritis: A randomized clinical trials.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/2633</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization by sealed envelope, Randomization description: The volunteers were divided among the treatment groups by using the closed envelopes.The closed were only available to a technician at the research center who was not a part of the research team.After the pre-treatment evaluation, patients were asked to select one envelope from a box containing several envelopes. After opening the envelope, the patient was referred to the therapist based on the patient's group number to begin treatment. Than the covariate adaptive randomization technique was used for group assignment ensuring a balanced assignment of participants over the covariates of pain severity, the K-L score, age and body mass index, Blinding description: Results were evaluated by a person who was not involved in the study design. She was only aware of the participants' illnesses and the consequences that need to be measured. So outcome assessor were blinded to the study purpose, number of groups, and treatment differences. She was also unaware of any patient group. The data analyzer was entered into the research group after completing the study. He was blind to all aspects of the study including purpose, groups, and treatments and he identified treatment groups as groups 1, 2 and 3 without recognizing the differences.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Knee osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Patients  treated for 4 weeks and 3 sessions per week by 20 minute electrical stimulation, educational leaflet, 5 minute continuous ultrasound therapy, hot pack and 3 set yoga exercise and 20 minute medial thrust gait training. Intervention 2: Intervention group 2: Patients  treated for 4 weeks and 3 sessions per week by 20 minute electrical stimulation, educational leaflet, 5 minute continuous ultrasound therapy, hot pack and 3 set quadriceps and hamstring strength training by the resistance flexion and extension knee exercise. Intervention 3: Intervention group: Patients will be treated for 4 weeks and 3 sessions per week by 20 minute electrical stimulation, educational leaflet, 5 minute continuous ultrasound therapy, hot pack and 20 minute walking exercise on treadmill.</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 I need to consult with the research team.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Zahednejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Jundishapur University of Medical Sciences, Esfand Avenue, Golestan</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15794-61357</zip>
        <telephone>+98 61 3161</telephone>
        <email>dr.shzahed@gmail.com</email>
        <affiliation>Ahvaz Jundishapur University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Zahednejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Jundishapur University of Medical Sciences, Esfand Avenue, Golestan</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15794-61357</zip>
        <telephone>+98 61 3161</telephone>
        <email>dr.shzahed@gmail.com</email>
        <affiliation>Ahvaz Jundishapur University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>having mild to moderate chronic osteoarthritis of unilaterally or bilaterally tibiofemoral joint according to the method of Kellgren and Lawrance
45-76 years old
a history of symptoms more than a month
being able to walk without assistant devices
having the recent anterior and lateral x-ray image of knee</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>76 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Reporting other diseases such as: diabetes, diseases of musculoskeletal, neuromuscular and uncontrolled diseases of cardiovascular, respiratory and uncontrolled hypertension
the use of injections or other invasive treatments (such as surgery) in the lower extremities during the last three months
having an artificial hip or knee joints
taking painkiller
history of trauma to knee joint during last week
performing regular professional exercise
extreme physical weakness</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M17</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Primary gonarthrosis, bilateral</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Patients  treated for 4 weeks and 3 sessions per week by 20 minute electrical stimulation, educational leaflet, 5 minute continuous ultrasound therapy, hot pack and 3 set yoga exercise and 20 minute medial thrust gait training.</i_keyword>
      <i_keyword>Intervention group 2: Patients  treated for 4 weeks and 3 sessions per week by 20 minute electrical stimulation, educational leaflet, 5 minute continuous ultrasound therapy, hot pack and 3 set quadriceps and hamstring strength training by the resistance flexion and extension knee exercise.</i_keyword>
      <i_keyword>Intervention group: Patients will be treated for 4 weeks and 3 sessions per week by 20 minute electrical stimulation, educational leaflet, 5 minute continuous ultrasound therapy, hot pack and 20 minute walking exercise on treadmill.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Knee joint loading. Timepoint: pre and post treatment and 1 month after treatment. Method of measurement: assesment of knee aduction moment by 3D motion analysis and force plate.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Functional activity. Timepoint: pre and post intervention and one month after intervention. Method of measurement: using of 2 minute walking test.</sec_outcome>
      <sec_outcome>Pain. Timepoint: study pre and post intervention and one month after intervention. Method of measurement: using of visual analogue scale and the short WOMAC scale.</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>Vice chancellor for research of Ahvaz Jundishapur University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-06-17</approval_date>
        <contact_name>Ahvaz Jundishapur University of Medical Sciences Ethics Committee</contact_name>
        <contact_address>Ahvaz Jundishapur University of Medical Sciences, Esfand Avenue, Golestan Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
