<?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>IRCT201608044641N12</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-02-06</date_registration>
      <primary_sponsor>Physical Medicine and Rehabilitation Research Center of Tabriz</primary_sponsor>
      <public_title>Effectiveness of Extra corporal Shock Wave therapy in the treatment of Knee Arthritis</public_title>
      <acronym></acronym>
      <scientific_title>Clinical Trial to comparison the effectiveness of Extra Corporal Shock Wave Therapy and other conventional physiotherapy interventions on the amount of  knee pain in patients With Moderate knee Osteoarthritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/4977</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Moderate knee osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: The control group will receive just exercise programs. Exercise program consists of strengthening exercise for quadriceps muscle, Isometric exercise with and without weight, weight bearing exercise inside and outside the water. Intervention 2: Intervention group 1: The patients will receive Shock Wave Therapy for the affected knee at the site with maximum pain amount in sitting position, flexion of knee joint and abduction and external rotation of hip joint, during 3 weeks; 2000 shock/session;  5 session; energy level 2-4; pulse rate 160/min; 6-10 Hz; density 0.18 mj/mm2; with zimmer shokwave device, made in Germany. Intervention 3: Group intervention 2:The patients will receive conventional physiotherapy interventions for 10 sessions which is consisted of 1) Hot Pack at 74.5 degrees centigrade for 20 minutes, at the knee region with maximum pain; and 2) TENS: pulse duration 20-100 Microsecond; 50% duty cycle; continuous amplitude  at the maximum pain region of affected knee; frequency&lt;200pps, and 3) Ultra Sound: 1MHz Frequency; intensity of 2.5 W/cm2; pulse at duty cycle of 25%; for 10 minute.</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>Dr Razieh Ahmadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emam Reza Hospital, Golgasht street,Tabriz .</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614756</zip>
        <telephone>+98 41 3337 3967</telephone>
        <email>ahmadi.dr62@gmail.com</email>
        <affiliation>Tabriz University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Bina Eftekhar Sadat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emam Reza Hospital, Golgasht street, Tabriz.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614756</zip>
        <telephone>+98 41 3337 3967</telephone>
        <email>binasadat@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: patients with moderate knee osteoarthritis grade 2 and 3, based on kellegren &amp;Lawrence scale; patients at the age of 50-70 years.&#13;
Exclusion criteria: patients with rheumatologic disorders such as rheumatoid arthritis; past medical history of surgery on knee joints; past medical history of fracture in lower limbs with involvement of articular surface of knees; mild and sever knee osteoarthritis ( 1 and 4 radiological scale); patients with electrical implants such as pace makers; past medical history of conduction block cardiac disease; patients with epileptic disorders; patients with pregnancy; patients with deep vein thrombosis; past medical history of intra-articular injections since 6 month ago and systemic corticosteroid drugs consumption since 1 month ago; patients with balance disturbance; patients with neuropathy and sensory impairments; existence of any skin lesions around the knee joints; BMI above 30; patients who are unable to complete the questionnaire and procedures.</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M17</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Gonarthrosis [arthrosis of knee]</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The control group will receive just exercise programs. Exercise program consists of strengthening exercise for quadriceps muscle, Isometric exercise with and without weight, weight bearing exercise inside and outside the water.</i_keyword>
      <i_keyword>Intervention group 1: The patients will receive Shock Wave Therapy for the affected knee at the site with maximum pain amount in sitting position, flexion of knee joint and abduction and external rotation of hip joint, during 3 weeks; 2000 shock/session;  5 session; energy level 2-4; pulse rate 160/min; 6-10 Hz; density 0.18 mj/mm2; with zimmer shokwave device, made in Germany</i_keyword>
      <i_keyword>Group intervention 2:The patients will receive conventional physiotherapy interventions for 10 sessions which is consisted of 1) Hot Pack at 74.5 degrees centigrade for 20 minutes, at the knee region with maximum pain; and 2) TENS: pulse duration 20-100 Microsecond; 50% duty cycle; continuous amplitude  at the maximum pain region of affected knee; frequency&lt;200pps, and 3) Ultra Sound: 1MHz Frequency; intensity of 2.5 W/cm2; pulse at duty cycle of 25%; for 10 minute.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The amount of Pain. Timepoint: Time zero(baseline), 3weeks later,7 weeks later. Method of measurement: Visual Analog Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Knee range of motin. Timepoint: Time zero (baseline),3weeks later,7 weeks later. Method of measurement: Goniometer.</sec_outcome>
      <sec_outcome>Knee function. Timepoint: Time zero (baseline),3weeks later,7 weeks later. Method of measurement: WOMAC questionnaire.</sec_outcome>
      <sec_outcome>HSCRP level. Timepoint: Time zero (baseline),final evaluation at week 7. Method of measurement: laberatory kit.</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>Physical Medicine and Rehabilitation Research Center of Tabriz</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-07-04</approval_date>
        <contact_name>Ethics comittee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Central building number2 (third floor), Tabriz University of Medical Sciences, Golgasgt street,Tabriz. Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
