<?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>IRCT201111214738N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-12-28</date_registration>
      <primary_sponsor>Shahid Bbeheshti University of Medical Sciences,  Vice Chancellor for Research</primary_sponsor>
      <public_title>the effect of distraction in the treatment of knee arthrosis</public_title>
      <acronym></acronym>
      <scientific_title>The effect of knee joint distraction on the pain and function of patients with severe knee osteoarthritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-07-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/5075</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>knee osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: Control group :    US, TENS, HOTPACK and EXERCISEUS is applied for 5 minutes to anterior, posterior knee in each session for ten sessions Conventional TENS is applies for 20 minutes in each session for 10 sessions2 hot packs are applied to anterior and posterior knee for 20 minutes in each session and for 10 sessions.2 exercises are trained to patients in 1st session. Intervention 2: case group interventions:    US, TENS, HOTPACK and EXERCISE + distractionUS is applied for 5 minutes to anterior, posterior knee in each session for ten sessionsConventional TENS is applies for 20 minutes in each session for 10 sessions2 hot packs are applied to anterior and posterior knee for 20 minutes in each session and for 10 sessions.2 exercises are trained to patients in 1st sessionSustain joint distraction is applied for 20 minutes in each session for 10 sessions.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Somaye Mahmoodi Aghdam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Damavand Ave, Faculty of rehabilitation</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 7756 1411</telephone>
        <email>smahmoodiaghdam@gmail.com</email>
        <affiliation>Faculty of rehabilitation, Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Khosro Khademi Kalantari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Damavand Ave, Faculty of Rehabilitation</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 7756 1411</telephone>
        <email>k_khademi@sbmu.ac.irkhosro_khademi@yahoo.co.uk</email>
        <affiliation>Faculty of Rehabilitation, Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
Female patients with sever knee OA (grade 3&amp;4 Kalgren Lawrence scale) with the age range between 45 and 75.&#13;
Exclusion criteria :&#13;
malignancy in knee joint, infection around the knee joint, metabolic disease, endocrine disorders, vascular disease, injection of corticosteroid in the last 30 days, recent start of use of anti-inflammatory medicine (in the last 30 days), open injuries in the knee, secondary osteoarthritis, history of knee fractures, surgery in the knee joint in the last 6 months, pain duration less than 1 year, knee joint hypermobility and ligamentus laxity, sever edema around the knee joint and psychological disorders. &#13;
- Feel of pain in the chest, breathlessness, leg cramps, tumbling, sever perspiration and pale appearance and inability for finishing the 6 minute walking test.&#13;
-Absence in two successive treatment sessions.</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>75 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M19.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Primary arthrosis NOS</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group :    US, TENS, HOTPACK and EXERCISEUS is applied for 5 minutes to anterior, posterior knee in each session for ten sessions Conventional TENS is applies for 20 minutes in each session for 10 sessions2 hot packs are applied to anterior and posterior knee for 20 minutes in each session and for 10 sessions.2 exercises are trained to patients in 1st session</i_keyword>
      <i_keyword>case group interventions:    US, TENS, HOTPACK and EXERCISE + distractionUS is applied for 5 minutes to anterior, posterior knee in each session for ten sessionsConventional TENS is applies for 20 minutes in each session for 10 sessions2 hot packs are applied to anterior and posterior knee for 20 minutes in each session and for 10 sessions.2 exercises are trained to patients in 1st sessionSustain joint distraction is applied for 20 minutes in each session for 10 sessions</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Functional ability. Timepoint: in the 1st session, 10th session and 1 month after treatment ends. Method of measurement: by 6 minute walking test.</prim_outcome>
      <prim_outcome>Amount of pain. Timepoint: in 1st to 10th session and 1 month after treatment ends. Method of measurement: by VAS measurement.</prim_outcome>
      <prim_outcome>Amount of joint effusion. Timepoint: in 1st to 10th session and 1 month after treatment ends. Method of measurement: by measurement tape over and 10 cm above and bellow knee joint line.</prim_outcome>
      <prim_outcome>Knee joint mobility. Timepoint: in 1st to 10th session and 1 month after treatment ends. Method of measurement: by goniometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life. Timepoint: in 1st and 10th session and 1 month after treatment ends. Method of measurement: 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>Shahid Bbeheshti University of Medical Sciences,  Vice Chancellor for Research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-10-30</approval_date>
        <contact_name>shahid Beheshti university of medical sciences</contact_name>
        <contact_address>Daneshjoo Ave, Evin Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
