<?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>IRCT2012081410599N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-01-30</date_registration>
      <primary_sponsor>Vice chancellor for research, Iran University of Medical Sciences</primary_sponsor>
      <public_title>Upper extremity pain management with stellate ganglion block</public_title>
      <acronym></acronym>
      <scientific_title>Clinical trial of Comparison of effectiveness  of stellate ganglion block under the guidance of fluoroscopy and ultrasonography  guidance in upper extremity complex regional pain  syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>14</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11061</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>Upper Extremities Complex regional pain syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Flouroscopic guide stellate ganglion block:  After select the  patient with block randomization method, first put   the C-ARM in AP view and specify the C6 or C7 vertebra. The desired location is the junction between the transverse process and the body of C6 or C7 vertebra. Five to 10 cm Needle plug to the extension tube while contact bone occurred. The needle will be positioned at anterolateral to the vertebral body. Longus colli located at lateral to vertebral body and medial to transverse process. Be aware that needle be in contact with the bone to avoid the longus colli injection. If paresthesia will  occurred the needle withdrawn and repositioned in another place. Intervention 2: Sono guide stellate ganglion block: After select the  patient  with block randomization method,the patient is placed in supine position with little head extension to contralateral side . We used the linear high frequency transducer (6-13 mhz) at C6 cervical vertebra. we must see the cutting of the  anatomical structures such as the C6 transverse process, longus colli muscle, prevertebral fascia, thyroid gland and carotid artery . The needle might be the path lateral to the carotid artery and is the preferred path.</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>karim Hemati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of pain, 4th Floor, Rasool Akram Hospital, Niayesh “St.”, Sattarkahn “St.”, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6655 3921</telephone>
        <email>khematy@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Poupak  Rahimzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of pain, 4th Floor, Rasool Akram Hospital, Niayesh “St.”, Sattarkahn “St.”, Tehran, Iran. P.O box: 14455- 364</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6650 9059</telephone>
        <email>popak-rah@hotmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Type1 and 2 CRPS, post-herpetic neuralgia, head and neck and upper limbs cancer pain, vascular pain, hyperhydrosis, vascular vasospasm, vasculopathy related Menier disease, post traumatic syndromes which cause cyanosis, cold hydrosis and inflammation. Exclusion criteria : anticoagulant therapy, pneumothorax or pneumonectomy in other side, recent MI, glaucoma and cardiac conduction anomaly.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M79.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pain in limb</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Flouroscopic guide stellate ganglion block:  After select the  patient with block randomization method, first put   the C-ARM in AP view and specify the C6 or C7 vertebra. The desired location is the junction between the transverse process and the body of C6 or C7 vertebra. Five to 10 cm Needle plug to the extension tube while contact bone occurred. The needle will be positioned at anterolateral to the vertebral body. Longus colli located at lateral to vertebral body and medial to transverse process. Be aware that needle be in contact with the bone to avoid the longus colli injection. If paresthesia will  occurred the needle withdrawn and repositioned in another place.</i_keyword>
      <i_keyword>Sono guide stellate ganglion block: After select the  patient  with block randomization method,the patient is placed in supine position with little head extension to contralateral side . We used the linear high frequency transducer (6-13 mhz) at C6 cervical vertebra. we must see the cutting of the  anatomical structures such as the C6 transverse process, longus colli muscle, prevertebral fascia, thyroid gland and carotid artery . The needle might be the path lateral to the carotid artery and is the preferred path.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: First , 6 hours and  2-7 days after that. Method of measurement: VAS ( standard tools for pain assessment).</prim_outcome>
      <prim_outcome>Affected upper extremity temperature. Timepoint: First , 6 hours and 2-7 days after that. Method of measurement: Thermometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Conjunctival and nasal congestion. Timepoint: Immediately after injection. Method of measurement: Visual.</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, Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-07-23</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences.</contact_name>
        <contact_address>Vice chancellor for research, Iran University of Medical Sciences, beside Milad Tower, Hemat exp way Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-09-23</approval_date>
        <contact_name></contact_name>
        <contact_address>   Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
