<?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>IRCT201010104549N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2010-10-24</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>Efficacy of laser on knee Arthrosis</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy of low level laser on knee osteoarthritis treatment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2009-09-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/4853</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Osteoarthritis of the knee joint.</hc_freetext>
      <i_freetext>Intervention 1: The standard treatment that applied to the each of two groups was 1-A 1 MHz continous mode Ultrasound with applicator cross section of 0/8 cm2 in medial and lateral aspect of joint line, duration of 5 min and intensity of 1 w/cm2 .2- TENS current with frequency of 100 Hz and pulse duration of 0/05 ms and the time of treatment of 15 min.3-Infra Red radiation with power of 250 watt and 45 cm distance from the knee4- SLR in supine position, 30 fold. In the control group A Gal-Al-As diode laser device with a power output of 30 mW and a wavelength of 830 nm was used. Probe of laser applied in pattern of cycloid grid in 5 points in antero-medial side and 5 points in the antero-lateral side of knee joint line. In Each session 3 j/per point and a total dosage of 30j/cm2 were applied. In the placebo group, the same points and the similar duration was applied while turned off the laser device. Intervention 2: The standard treatment that applied for the control group was 1-A 1 MHz continous mode  Ultrasound with applicator cross section of 0/8 cm2 in medial and lateral aspect of joint line, duration of 5 min and intensity of 1 w/cm2 .2- TENS current with frequency of 100 Hz and pulse duration of 0/05 ms and the time of treatment of 15 min.3-Infra Red radiation with power of 250 watt and 45 cm distance from the knee 4- Straight Leg Raising in supine position, 30 fold. The same Gal-Al-As diode laser device was applied on the same points as the Active laser group while turned off the laser device. Probe of laser was applied in pattern of cycloid grid in 5 points in antero-medial side and 5 points in the antero-lateral side of knee joint line. The duration of treatment on each point was 30 second.</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>Rasool Bagheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Highway of Jalal Ale Ahmad, Tarbiat Modares University, Department of Physiotherapy</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 23 1446 1580</telephone>
        <email>rasool.bagheri@ymail.com</email>
        <affiliation>Tarbiat Modares University of Tehran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rasool Bagheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jalal Ale Ahmad Highway, Tarbiat Modares University,Department of Physiotherapy</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 23 1446 1580</telephone>
        <email>rasool.bagheri@ymail.com</email>
        <affiliation>Tarbiat Modares University of Tehran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Presence of Idiopathic unilateral knee OA, age 45-75 years, ability of walking, having local pain in the knee region that was greater than 5 with regard to VAS and greater than 48 with regard to the WOMAC scale, &#13;
Exclusion criteria: having other disorders of knee, affecting hip and ankle joints, lumbar spine pathology, presence of intra-articular effusion, past history of physical therapy or injection into the joint space since 6 months ago, presence of any infection, active bleeding, past history of knee joint surgery</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</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 of other joints</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The standard treatment that applied to the each of two groups was 1-A 1 MHz continous mode Ultrasound with applicator cross section of 0/8 cm2 in medial and lateral aspect of joint line, duration of 5 min and intensity of 1 w/cm2 .2- TENS current with frequency of 100 Hz and pulse duration of 0/05 ms and the time of treatment of 15 min.3-Infra Red radiation with power of 250 watt and 45 cm distance from the knee4- SLR in supine position, 30 fold. In the control group A Gal-Al-As diode laser device with a power output of 30 mW and a wavelength of 830 nm was used. Probe of laser applied in pattern of cycloid grid in 5 points in antero-medial side and 5 points in the antero-lateral side of knee joint line. In Each session 3 j/per point and a total dosage of 30j/cm2 were applied. In the placebo group, the same points and the similar duration was applied while turned off the laser device.</i_keyword>
      <i_keyword>The standard treatment that applied for the control group was 1-A 1 MHz continous mode  Ultrasound with applicator cross section of 0/8 cm2 in medial and lateral aspect of joint line, duration of 5 min and intensity of 1 w/cm2 .2- TENS current with frequency of 100 Hz and pulse duration of 0/05 ms and the time of treatment of 15 min.3-Infra Red radiation with power of 250 watt and 45 cm distance from the knee 4- Straight Leg Raising in supine position, 30 fold. The same Gal-Al-As diode laser device was applied on the same points as the Active laser group while turned off the laser device. Probe of laser was applied in pattern of cycloid grid in 5 points in antero-medial side and 5 points in the antero-lateral side of knee joint line. The duration of treatment on each point was 30 second.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain at rest. Timepoint: before first session and after tenth session. Method of measurement: on basis of VAS.</prim_outcome>
      <prim_outcome>Duration of morning stiffness. Timepoint: in the onset of first session and after the final session. Method of measurement: recording of the duration via the patients at minute and quastion of their.</prim_outcome>
      <prim_outcome>Active Kee flexion Range of Motion. Timepoint: onset of first session and after the tenth session. Method of measurement: via the goniometer by  therapist.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: onset of first session and after the tenth session. Method of measurement: via questioning of patients on the basis of WOMAC index.</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>Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date></approval_date>
        <contact_name>Semnan University of Medical Sciences</contact_name>
        <contact_address>Kilometer 5, Damghan Road Semnan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
