<?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>IRCT20171107037306N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-12-17</date_registration>
      <primary_sponsor>Rofeideh Rehabilitation Hospital</primary_sponsor>
      <public_title>Effectiveness of attention bias modification and Trance cranial direct current stimulation on reduction of pain and  attention bias.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of  the effectiveness of attention bias modification (ABM) with/without  Trance cranial direct current stimulation  (TDCS) on reduction of attention bias and severity of perceived pain in chronic low back pain patients.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/27636</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, the subjects are randomly assigned into intervention, control, and placebo groups using random number table. Sealed non-transparent envelopes with random sequence were used to conceal random assignment. Following constructing random sequence by random table, 60 envelopes with aluminum wrappers (in order to obscure the envelopes) were prepared based on the research sample size, and each of random sequences was recorded on a card, and the cards were placed in the envelopes in order.  External surface of the envelopes are numbered in the same order for preserving random sequence. Based on the order by which the qualified subjects entered to the study, the envelopes were opened and the assigned group for the subject was specified, Blinding description: First, the physician interviewed with the patients considering inclusion and exclusion criteria. Then, individuals qualified with inclusion criteria, who were content with participation in the research, were introduced to the interviewer and he conducted the primary evaluation. The subjects were then referred to the therapist and were randomly assigned into the intervention or placebo groups. After intervention, the subjects were introduced to the examiner author, and secondary evaluation was carried out. Second examiner was unaware of assignment of subjects in intervention groups. Thus, the subjects, outcome valuator (second examiner), and clinical care provider were kept blind toward the group assignments in this study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>chronic low back pain.</hc_freetext>
      <i_freetext>Intervention 1: The second experimental group receive the attention bias modification task combined with trance cranial direct current stimulation through 5 sessions  of 20 minutes. Intervention 2: placebo group receive sham Trance cranial direct current stimulation.(TDCS). Intervention 3: One of the experimental groups receives attention bias modification task by computer through 5 sessions of 20 minutes . Intervention 4: control group answer the questionnaire and dont receive any intervention.</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></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shima Shakiba</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nematy Ave, Soleimany Ave, Gheitaerh</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1935973476</zip>
        <telephone>+98 21 2223 3017</telephone>
        <email>shimashakibash.psy@gmail.com</email>
        <affiliation>Rofeideh Rehabilitation Hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Yasaman Shiasy</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Koodakyar Ave, Daneshjo Blv, Evin, Tehan</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1993696691</zip>
        <telephone>+98 21 8803 7571</telephone>
        <email>syasaman@rocketmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 20 and 50 years.
ability for writing and reading.
low back pain more than 3 months.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Substance and addictive disorder.
Psychiatric disorder( psychosis or bipolar disorder).
Migraine or recurrent headaches.
Brain injury.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F45.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pain disorders related to psychological factors.</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Placebo</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The second experimental group receive the attention bias modification task combined with trance cranial direct current stimulation through 5 sessions  of 20 minutes.</i_keyword>
      <i_keyword>placebo group receive sham Trance cranial direct current stimulation.(TDCS)</i_keyword>
      <i_keyword>One of the experimental groups receives attention bias modification task by computer through 5 sessions of 20 minutes .</i_keyword>
      <i_keyword>control group answer the questionnaire and dont receive any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity  of perceived  pain. Timepoint: Before intervention,one week  after intervention,one month after intervention. Method of measurement: Visual analog scale-  questionnaire of severity of chronic pain questinnaire.</prim_outcome>
      <prim_outcome>Attention bais. Timepoint: Before intervention,one week  after intervention,one month after intervention. Method of measurement: Dot probe test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Depression. Timepoint: Before intervention,one week after intervention,one month after intervention. Method of measurement: DASS questionnaire.</sec_outcome>
      <sec_outcome>Disability due to pain. Timepoint: Before intervention,one week after intervention,one month after intervention. Method of measurement: Roland &amp; Moris disability questionnaire.</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>Rofeideh Rehabilitation Hospital</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-08-01</approval_date>
        <contact_name>Ethics committee of university of Social Welfare and Rehabilitation Sciences</contact_name>
        <contact_address>Koodakyar Ave, Daneshjo Blvd ,Evin, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
