<?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>IRCT20181216042010N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-25</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of transcranial direct stimulationof different brain cortex areas plus the traditional physical therapy on pain and function of subjects with knee osteoarthritis</public_title>
      <acronym>tDCS</acronym>
      <scientific_title>The Effect of transcranial direct stimulationof different brain cortex areas plus the traditional physical therapy on pain intensity and clinical functional ability of subjects with knee osteoarthritis: “A randomised controlled trial”</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36024</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: NO, Randomization description: Randomization is a simple randomization method that is performed using 4 sealed envelopes containing group names based on the type of intervention, Blinding description: The  assessor physiotherapist  and participants are blind.</study_design>
      <phase>N/A</phase>
      <hc_freetext>knee osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  traditional Physiotherapy(Ultrasound, Infra-Red, Trans- cutaneous Electrical Nerve Stimulation, Exercise therapy) with trans-cranial direct current stimulation of primary motor cortex for ten sessions. Intervention 2: Intervention group:  traditional Physiotherapy traditional Physiotherapy(Ultrasound, Infra-Red, Trans- cutaneous Electrical Nerve Stimulation, Exercise therapy)  with transcranial direct current stimulation of primary sensory cortex for ten sessions. Intervention 3: Intervention group:  traditional Physiotherapy traditional Physiotherapy(Ultrasound, Infra-Red, Trans- cutaneous Electrical Nerve Stimulation, Exercise therapy)  with transcranial direct current stimulation of dorsolateral perfrontal cortex for ten sessions. Intervention 4: Control group: traditional Physiotherapy  traditional Physiotherapy(Ultrasound, Infra-Red, Trans- cutaneous Electrical Nerve Stimulation, Exercise therapy) with  sham transcranial direct current stimulation for ten 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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Gholmhosein Nassaj</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rehabilitation school of Ahvaz Jundishapour university, Golestan highway, Ahvaz</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>33133 -61357</zip>
        <telephone>+98 613337431011162</telephone>
        <email>nassadj@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Gholamhosein Nassaj</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rehabilitation school of Jundishapour university, Golestan highway, Ahvaz</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>33133 -61357</zip>
        <telephone>+98 613337431011162</telephone>
        <email>nassadj@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Individuals aged 50-70 years
Individuals with grades 2 and 3 of OA to the diagnosis of orthopedics by System Kellgren and Lawrence
Having at least 3 signs of the 6 clinical symptoms of the American College of Rheumatology
People with dominant right leg involvement (in the case of bilateral, the right lesion is also dominant)
Minimal pain 4 according to the visual scale of pain</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having knee surgery for the last six months
Replacing the knee joint or tibia osteotomy on the affected side
Neurological conditions affecting organ function (Parkinson's disease, stroke and multiple sclerosis)
Inability to walk without help
History of another rheumatic disease that causes secondary osteoarthritis
People  with lack of sensation and epilepsy whom pain modification techniques are prohibited</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M17.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unilateral primary osteoarthritis of knee</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  traditional Physiotherapy(Ultrasound, Infra-Red, Trans- cutaneous Electrical Nerve Stimulation, Exercise therapy) with trans-cranial direct current stimulation of primary motor cortex for ten sessions</i_keyword>
      <i_keyword>Intervention group:  traditional Physiotherapy traditional Physiotherapy(Ultrasound, Infra-Red, Trans- cutaneous Electrical Nerve Stimulation, Exercise therapy)  with transcranial direct current stimulation of primary sensory cortex for ten sessions</i_keyword>
      <i_keyword>Intervention group:  traditional Physiotherapy traditional Physiotherapy(Ultrasound, Infra-Red, Trans- cutaneous Electrical Nerve Stimulation, Exercise therapy)  with transcranial direct current stimulation of dorsolateral perfrontal cortex for ten sessions</i_keyword>
      <i_keyword>Control group: traditional Physiotherapy  traditional Physiotherapy(Ultrasound, Infra-Red, Trans- cutaneous Electrical Nerve Stimulation, Exercise therapy) with  sham transcranial direct current stimulation for ten sessions</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: before initiation of treatment, 10 session, 1 month ago. Method of measurement: Visual Analogue Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Function. Timepoint: before initiation of treatment, 10 session, 1 month ago. Method of measurement: questionnaire and tests.</sec_outcome>
      <sec_outcome>Strength of muscle. Timepoint: before initiation of treatment, 10 session, 1 month ago. Method of measurement: dynamometer.</sec_outcome>
      <sec_outcome>Range of motion. Timepoint: before initiation of treatment, 10 session, 1 month ago. Method of measurement: goniameter.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-10-20</approval_date>
        <contact_name>Ethics committee of Ahvaz Jundishapour University of Medical Sciences</contact_name>
        <contact_address>Golestan high way Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
