<?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>IRCT2017070934969N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-08-30</date_registration>
      <primary_sponsor>Deputy of Research and Technology, Semnan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of transcranial direct current stimulation(TDCS) with postural training on balance, static and dynamic standing postural stability in the patients with chronic low back pain(CLBP)</public_title>
      <acronym></acronym>
      <scientific_title>The effect of transcranial direct current stimulation(TDCS) with postural training on balance, static and dynamic standing postural stability in the patients with chronic low back pain(CLBP)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>10</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26575</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: All participants will be requested to stand on each static and dynamic surfaces of Byodex Balance System for 30 seconds in before and after transcranial direct current stimulation. In the intervention of TDCS, the anode and cathode electrodes respectively will be placed on primary motor cortex and contralateral supraorbital area and the stimulation will be applied with 2 milliamps intensity for 20 minutes. The postural training with TDCS intervention will be performed for 3 sessions per week for 2 weeks. Intervention 2: Control group: All participants will be requested to stand on static and dynamic surfaces of Byodex Balance System for 30-second in before and after postural training with sham-TDCS intervention. In sham-TDCS intervention, anode and cathode electrodes respectively will be placed on primary motor cortex and contralateral supraorbital area. Stimulations will be applied with 2 milliamps intensity for 30 seconds. Postural training with sham-TDCS intervention will be performed for 3 sessions per week for 2 weeks. Intervention 3: Control group: All participants will be requested to stand on static and dynamic surfaces of Byodex Balance System for 30-second in before and after just postural training. Postural training alone will be performed for 3 sessions per week for 2 weeks.</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>fatemeh ehsani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Blvd Ghods, Semnan</address>
        <city>semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 23 3365 4180</telephone>
        <email>fatemehehsani59@yahoo.com; jafarzadehabbas8005@yahoo.com</email>
        <affiliation>Neuromuscular Rehabilitation Research Center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>fatemeh ehsani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Blvd Ghods, Semnan</address>
        <city>semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 23 3365 4180</telephone>
        <email>fatemehehsani59@yahoo.com; jafarzadehabbas8005@yahoo.com</email>
        <affiliation>Neuromuscular Rehabilitation Research Center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Volunteer patients with chronic low back pain (CLBP) who are between ages of 18 to 40 years and they have chronic back pain for at least 3 months (12 weeks) by medical diagnosis and physiotherapy, and as well as peoples who will be entered into study to signed the informed consent form. The exclusion criteria are include the patients with other chronic pain syndromes, spinal cord surgery in the last 6 months, neurological diseases, rheumatology and psychiatric diseases, pregnancy or getting pregnant during the study, use of pacemakers or any other instrument in the body, previous treatments with transcranial direct current stimulation (TDCS), specific pathologies in the spinal cord (fracture, neoplasm, deformity, Schuermann's disease, infection, radiculopathy, vertebral fractures or spondylolisthesis), use of medication and drug or alcohol abuse, participation in athletic activities and not athlete, vestibular disorders, use of drugs that affecting on balance and history of migraine</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Low back pain</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>Intervention group: All participants will be requested to stand on each static and dynamic surfaces of Byodex Balance System for 30 seconds in before and after transcranial direct current stimulation. In the intervention of TDCS, the anode and cathode electrodes respectively will be placed on primary motor cortex and contralateral supraorbital area and the stimulation will be applied with 2 milliamps intensity for 20 minutes. The postural training with TDCS intervention will be performed for 3 sessions per week for 2 weeks.</i_keyword>
      <i_keyword>Control group: All participants will be requested to stand on static and dynamic surfaces of Byodex Balance System for 30-second in before and after postural training with sham-TDCS intervention. In sham-TDCS intervention, anode and cathode electrodes respectively will be placed on primary motor cortex and contralateral supraorbital area. Stimulations will be applied with 2 milliamps intensity for 30 seconds. Postural training with sham-TDCS intervention will be performed for 3 sessions per week for 2 weeks.</i_keyword>
      <i_keyword>Control group: All participants will be requested to stand on static and dynamic surfaces of Byodex Balance System for 30-second in before and after just postural training. Postural training alone will be performed for 3 sessions per week for 2 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Static and dynamic stability indices. Timepoint: Before and after receiving after intervention. Method of measurement: Byodex Balance System.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Balance. Timepoint: Before and after receiving intervention. Method of measurement: Berg balance scale.</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>Deputy of Research and Technology, Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-16</approval_date>
        <contact_name>Ethics committee of Semnan university of medical science</contact_name>
        <contact_address>Semnan، University of Medical Sciences Semnan، 5 km road Damghan ،Faculty of Rehabilitation semnan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
