<?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>IRCT201606173220N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-09-21</date_registration>
      <primary_sponsor>Rafsanjan University of Medical sciences</primary_sponsor>
      <public_title>The effect of electroacupuncture and laser on knee osteoarthritis</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of electroacupancture and low level laser in the treatment of the knee joint osteoarthritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-06-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/3285</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: None.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Knee osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: First group will receive electroacupuncture (needle is inserted to acupuncture points of knee osteoarthritis , then electrical stimulation through simulator set, connect to patients body, Ying Di, KWD 808, made in china, 3Hz and 20 minutes). Intervention 2: Second group will receive low level laser (Ga Al As, 810nm, 100mv) 6j intensity and 10 minutes per session during 10 session on 10  acupuncture points of the knee joints). Intervention 3: Third group (placebo): the sets of electroacupuncture and laser are turn on but no radiation or electricity don't receive on knee osteoarthritis.</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>Dadollah Shahimoridi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Educational Assistant, Central Organization of Rafsanjan University of Medical Sciences, Emam Ali Blvd</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7717893591</zip>
        <telephone>+98 34 3426 2926</telephone>
        <email>d_shahimoridi@rums.ac.ir</email>
        <affiliation>Rafsanjan University of Medical sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dadollah Shahimoridi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Educational Assistant, Central Organization of Rafsanjan University of Medical Sciences, Emam Ali Blvd</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7717893591</zip>
        <telephone>+98 34 3435 5286</telephone>
        <email>d_shahimoridi@rums.ac.ir</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion: having 45-75 years, knee pain more than 3 months, ability of walking, osteophyte in knee, reduction of joint space, crepitation of knee movement, grade 2 and 3. osteoarthritis of the knee.&#13;
&#13;
Exclusion criteria are injection of corticosteroids during previous 1 month, fracture, dislocation and previous surgery of the knee, pregnancy, rheumatoid arthritis and sever knee osteoarthritis (grade 4).</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>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First group will receive electroacupuncture (needle is inserted to acupuncture points of knee osteoarthritis , then electrical stimulation through simulator set, connect to patients body, Ying Di, KWD 808, made in china, 3Hz and 20 minutes).</i_keyword>
      <i_keyword>Second group will receive low level laser (Ga Al As, 810nm, 100mv) 6j intensity and 10 minutes per session during 10 session on 10  acupuncture points of the knee joints).</i_keyword>
      <i_keyword>Third group (placebo): the sets of electroacupuncture and laser are turn on but no radiation or electricity don't receive on knee osteoarthritis.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity at rest. Timepoint: 1st, 5th, 10th session and 1 month after end of treatment. Method of measurement: By Visual Analogue Scale (VAS).</prim_outcome>
      <prim_outcome>Inflamation around knee joints. Timepoint: 1st, 5th, 10th session and 1 month after end of treatment. Method of measurement: By meter (cm).</prim_outcome>
      <prim_outcome>Knee movements. Timepoint: 1st, 5th, 10th session and 1 month after end of treatment. Method of measurement: By goniameter.</prim_outcome>
      <prim_outcome>6 minutes walking test. Timepoint: 1st, 5th, 10th session and 1 month after end of treatment. Method of measurement: By chronometer.</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>Rafsanjan University of Medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-07-20</approval_date>
        <contact_name>The ethics committee of Rafsanjan University of Medical sciences</contact_name>
        <contact_address>Centeral Organization of Rafsanjan University of Medical Sciences, Emam Ali Blvd Rafsanjan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
