<?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>IRCT20171113037432N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-01-02</date_registration>
      <primary_sponsor>EMG-NCV institution of khatam alanba clinic</primary_sponsor>
      <public_title>The effect of corticosteroid injection in carpal tunnel syndrom</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of intraoperative local Dexamethasone injection in carpal tunnel release on symptoms and EMG-NCV.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-02-18</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/27699</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: none, Randomization description: randomization was based on a computer randomized number chart. each patient was granted a randomized number due to order of referral. the number specifies which group it belongs to, Blinding description: This is a double-blinded design study.the patient and the center taking the EMG-NCV records and the colleague gathering the information of the questionnarie from patients are blinded to which patient belongs to which group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Carpal tunnel syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Control group : The surgery begins with a 4cm volar skin incision starting from distal to the distal wrist crease in line with the third web space. then transverse carpal ligament and 2cm of distal antebrachial fascia is completely incised and the median nerve is released, the median nerve and the tunnel are explored for possible pathologies, the wound is irrigated and skin is closed. Intervention 2: Intervention group : The surgery begins with a 4cm volar incision starting from distal to the distal wrist crease in line with the third web space. then transverse carpal ligament and 2cm of distal antebrachial fascia is completely incised and the median nerve is released, the median nerve and the tunnel are explored for possible pathologies and the wound is irrigated in this step 1ml of dexamethasone with 4 mili-gram in one mili-liter concentration is injected in the flexor tendon sheath and in borders of the transverse ligament cuts and spilled around the median nerve, the difference between two study groups is just in this step and other surgical steps are the same for both groups. then the skin is closed.</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>dr. mostafa zare mehrjardi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>yazd bahonar square</address>
        <city>yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915173149</zip>
        <telephone>+353 8203410</telephone>
        <email>m.zaremehrjardi@ssu.ac.ir</email>
        <affiliation>shahid sadooghi univercity of medical siences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>dr. mostafa zare mehrjardi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bahonar square, Yazd</address>
        <city>yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915173149</zip>
        <telephone>+353 8202632</telephone>
        <email>m.zaremehrjardi@ssu.ac.ir</email>
        <affiliation>shahid sadooghi univercity of medical siences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who come to Yazd's Shahid Rahnemoon clinic, Khatam Alanbia clinic and Baghaiee poor clinic who are suspected to have carpal tunnel syndrome by symptoms. then they are diagnosed  by delay in distal motor reaction by 4.5 ms and sensory nerve conduction velocity of more than 3.5 ms in EMG-NCV.
Age of less than 65 and more than 25
Doesn't have known autoimmune or collagen vascular disease
Symptoms of no more than 2 years
No history of recent systemic corticosteroid consumption</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>median nerve pathologic condition encountered during surgery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G56.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Carpal tunnel syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group : The surgery begins with a 4cm volar skin incision starting from distal to the distal wrist crease in line with the third web space. then transverse carpal ligament and 2cm of distal antebrachial fascia is completely incised and the median nerve is released, the median nerve and the tunnel are explored for possible pathologies, the wound is irrigated and skin is closed.</i_keyword>
      <i_keyword>Intervention group : The surgery begins with a 4cm volar incision starting from distal to the distal wrist crease in line with the third web space. then transverse carpal ligament and 2cm of distal antebrachial fascia is completely incised and the median nerve is released, the median nerve and the tunnel are explored for possible pathologies and the wound is irrigated in this step 1ml of dexamethasone with 4 mili-gram in one mili-liter concentration is injected in the flexor tendon sheath and in borders of the transverse ligament cuts and spilled around the median nerve, the difference between two study groups is just in this step and other surgical steps are the same for both groups. then the skin is closed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Improvement in symptoms. Timepoint: just before surgery and 2 weeks after surgery. Method of measurement: questionnarie value is the sum of nembers given to each symptom and is a integer.</prim_outcome>
      <prim_outcome>EMG-NCV records for median nerve. Timepoint: first in one month before surgery and second time 3 month after surgery. Method of measurement: the time that impulse pass through nerve and is measured by milli-seconds.</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>EMG-NCV institution of khatam alanba clinic</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-10-04</approval_date>
        <contact_name>Ethics committee of shahid sadooghi university of medical sciences of yazd</contact_name>
        <contact_address>yazd, alam square yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
