<?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>IRCT2016031327036N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-05-05</date_registration>
      <primary_sponsor>Vice chancellor for research,Mashhad university of medical sciences</primary_sponsor>
      <public_title>efficacy of acupuncture on symptoms of htlv1 patients</public_title>
      <acronym></acronym>
      <scientific_title>Study of the efficacy of acupuncture in the  control of patients’ symptoms with HTLV1 Associated Myelopathy/Tropical Spastic Paraparesis (HAM/TSP(</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22261</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: HTLV1 Associated Myelopathy/Tropical Spastic Paraparesis (HAM/TSP). Condition 2: HTLV1 Associated Myelopathy/Tropical Spastic Paraparesis (HAM/TSP).</hc_freetext>
      <i_freetext>Intervention: &#13;
In this study, the intervention is semi-experimental with pretest and posttest measure design. The patients will be neurologically examined in clinic and their peripheral blood samples will be evaluated for detection of viral load. Subsequently, the patients will receive acupuncture treatment three sessions a week for four weeks. The patients will be neurologically reexamined and  for the second time the blood viral loads will be measured immediately after the intervention. Then, the same evaluation is planned to be performed three months after initial therapy using the described criteria..</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>Dr Amirali Ghahremani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Knowledge and Health City,In the end of Shahid Fakouri Blvd, Mashhad,Iran</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>99191-91778</zip>
        <telephone>+98 51 38049</telephone>
        <email>ghahremaniaa921@mums.ac.ir؛ shoeibia@gmail.com</email>
        <affiliation>Mashahd university of medical</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Ali Shoeibi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Knowledge and Health City,In the end of Shahid Fakouri Blvd, Mashhad,Iran</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9919191778</zip>
        <telephone>+98 51 38049</telephone>
        <email>shoeibia@mums.ac.ir؛ shoeibia@gmail.com</email>
        <affiliation>Mashhad university of medical</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
Informed consent, and confirmation of HAM / TSP according to World Health Organization (WHO) criteria        &#13;
 Exclusion criteria: &#13;
Patients who have contraindications for acupuncture such as wound or skin infection at the time of acupuncture therapy or bleeding diathesis; patients who suffer from other illness that may exacerbate the paraparesis such as vitamin B12 deficiency.&#13;
The intervention is acupuncture.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G04.1</hc_code>
      <hc_code>B33.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Tropical spastic paraplegia</hc_keyword>
      <hc_keyword>Retrovirus infections, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention: &#13;
In this study, the intervention is semi-experimental with pretest and posttest measure design. The patients will be neurologically examined in clinic and their peripheral blood samples will be evaluated for detection of viral load. Subsequently, the patients will receive acupuncture treatment three sessions a week for four weeks. The patients will be neurologically reexamined and  for the second time the blood viral loads will be measured immediately after the intervention. Then, the same evaluation is planned to be performed three months after initial therapy using the described criteria.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Spastic Paraparasy. Timepoint: Before the intervention and After the intervention then three months after the intervention. Method of measurement: on basis of Criterion ashworth.</prim_outcome>
      <prim_outcome>Incontinency. Timepoint: Before the intervention and After the intervention then three months after the intervention. Method of measurement: on basis of Criterion ICIQ-SF.</prim_outcome>
      <prim_outcome>Back pain. Timepoint: Before the intervention and After the intervention then three months after the intervention. Method of measurement: on basis of Criterion VAS.</prim_outcome>
      <prim_outcome>Disability. Timepoint: Before the intervention and After the intervention then three months after the intervention. Method of measurement: on basis of Criterion OMDS.</prim_outcome>
      <prim_outcome>Viral load. Timepoint: Before the intervention After the intervention, three months after the intervention. Method of measurement: DNA copy number of virus per mononuclear cells.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>-. Timepoint: -. Method of measurement: -.</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>Vice chancellor for research,Mashhad university of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-05-27</approval_date>
        <contact_name>Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Township health knowledge, Fakury boulevard,Mashhad University of Medical Sciences, Mashhad, Iran Mashhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
