<?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>IRCT2015072016532N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-04-21</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of intermittent vacuum in knee osteoarthritis</public_title>
      <acronym></acronym>
      <scientific_title>The comparison of the effect of intermittent vacuum in combination with conventional physical  therapy and conventional physical  therapy on pain intensity , knee range of motion and functional disability in patients with knee osteoarthritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>26</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15453</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization based on block randomization method.</study_design>
      <phase>N/A</phase>
      <hc_freetext>knee osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group will be received conventional physical treatment (including TENS, US, hot pack) and intermittent vacuum for 10 sessions in two weeks. The patients will perform quadriceps setting exercise. Other knee exercises as an exercise program will be taught to patients in tenth session.&#13;
For vacuum therapy, the cups of devices will be located on medial and lateral sides of knee joint. The pressure of vacuum is 150 milibar with duty cycle of 2 seconds. The total time of vacuum therapy is 10 minutes. The frequency and duration of TENS are 2 Hz and 200 milliseconds respectively. The intensity of TENS will be set by patient`s tolerance. The total time of treatment by TENS is 20 minutes. The one MHz ultrasound with intensity of 0.8w/cm² will be used by 5 minutes.Hot pack will be used by 20 minutes. Intervention 2: The control group will be received conventional physical treatment (including TENS, US, hot pack) for 10 sessions in two weeks. The patients will perform quadriceps setting exercise. Other knee exercises as an exercise program will be taught to patients in tenth session.&#13;
 The frequency and duration of TENS are 2 Hz and 200 milliseconds respectively. The intensity of TENS will be set by patient`s tolerance. The total time of treatment by TENS is 20 minutes. The one MHz ultrasound with intensity of 0.8w/cm² will be used by 5 minutes.Hot pack will be used by 20 minutes.</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>Sara Abolahrari Shirazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>POBox: 71345-1733, Rehabilitation Sciences Faculty, Abiverdi 1 street, Chamran Blvd., Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71947-33669</zip>
        <telephone>+98 71 3627 1552</telephone>
        <email>sa_ahrari@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences, Rehabilitation Sciences Faculty</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>farahnaz ghafarinejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>POBox: 71345-1733, Rehabilitation Sciences Faculty, Abiverdi 1 street, Chamran Blvd., Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71947-33669</zip>
        <telephone>+98 71 3627 1552</telephone>
        <email>ghafarif@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences, Rehabilitation Sciences Faculty</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:patients aged between 45 to 65  years old with knee osteoarthritis that are diagnosed by physician and knee knee osteoarthritis grade 1 to3 according to the Kellgren . Lawrence classification; without any cupping treatment until present; the presence of knee pain more than 3 months.&#13;
Exclusion criteria:The history of fracture or surgery on knee joint; history of  systemic inflammatory disease; Low back pain;  neuropathy;  myopathy; knee deformity, the usage of anticoagulant drugs;  platelet deficiency;  history of corticosteroid injection in knee joint during the past 6 months</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M17.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Gonarthrosis, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group will be received conventional physical treatment (including TENS, US, hot pack) and intermittent vacuum for 10 sessions in two weeks. The patients will perform quadriceps setting exercise. Other knee exercises as an exercise program will be taught to patients in tenth session.&#13;
For vacuum therapy, the cups of devices will be located on medial and lateral sides of knee joint. The pressure of vacuum is 150 milibar with duty cycle of 2 seconds. The total time of vacuum therapy is 10 minutes. The frequency and duration of TENS are 2 Hz and 200 milliseconds respectively. The intensity of TENS will be set by patient`s tolerance. The total time of treatment by TENS is 20 minutes. The one MHz ultrasound with intensity of 0.8w/cm² will be used by 5 minutes.Hot pack will be used by 20 minutes.</i_keyword>
      <i_keyword>The control group will be received conventional physical treatment (including TENS, US, hot pack) for 10 sessions in two weeks. The patients will perform quadriceps setting exercise. Other knee exercises as an exercise program will be taught to patients in tenth session.&#13;
 The frequency and duration of TENS are 2 Hz and 200 milliseconds respectively. The intensity of TENS will be set by patient`s tolerance. The total time of treatment by TENS is 20 minutes. The one MHz ultrasound with intensity of 0.8w/cm² will be used by 5 minutes.Hot pack will be used by 20 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity. Timepoint: Before and after intervention. Method of measurement: Using visual analog scale.</prim_outcome>
      <prim_outcome>Disability. Timepoint: Before and after intervention. Method of measurement: Using WOMAC questionnaire.</prim_outcome>
      <prim_outcome>Knee range of motion. Timepoint: Before and after intervention. Method of measurement: Using digital camera, marker and image j software.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-06-30</approval_date>
        <contact_name>Shiraz University of Medical Sciences</contact_name>
        <contact_address>Zand Blv. Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
