<?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>IRCT20200814048399N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-01</date_registration>
      <primary_sponsor>Combined Military Hospital Multan</primary_sponsor>
      <public_title>Evaluation of Amplitude, Velocity and  Latency Period of Sensory Nerve Action Potential of Proximal Part of Medial Branch of Superficial Radial Nerve for Diagnosis of Cheiralgia Paresthetica in Patients vs Control: A Randomized Control Trial</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of Amplitude, Velocity and  Latency Period of Sensory Nerve Action Potential of Proximal Part of Medial Branch of Superficial Radial Nerve for Diagnosis of Cheiralgia Paresthetica in Patients vs Control: A Randomized Control Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-10-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>26</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50536</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Blinding description: Patients with abnormal and normal sensation on dorsum of the hand will be de-identified at the reception counter and will be given randomly generated numbers by the help of website (https://www.random.org/) in place of their names by the receptionist. They EMG / NCS will then be performed on these patients by a physician and Amplitude Velocity and Latency period of Sensory Nerve Action Potential (SNAP) will be written by hand on a separate paper with out mentioning the name or diagnosis of patient and enclosed in the envelop with number of patient mentioned outside the envelop. The reports of  EMG/NCS will then be segregated into two groups viz Group-I (patients with abnormal sensation) and Group-II (Control) by a separate staff member. The data of patients in each group will then be uploaded by another staff member on SPSS who do not know which group is control and which is intervention group. After that, data sheet will then be analysed by separate statistician who will not be informed regarding which group is control and which is intervention group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cheiralgia Paresthetica.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:. Intervention 2: Control group:.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Individual participant data that underlie the results reported in this article after de-identification will be shared beginning 3 months and ending 5 years following article publication with researchers who provide a methodologically sound proposal to achieve the aims mentioned in the approved proposal. Proposals should be sent to tawabkhallil2013@gmail.com. To gain access data requestors will need to sign data access agreement.

When:
Beginning 3 months and ending 5 years following article publication with researchers who provide a methodologically sound proposal to achieve the aims mentioned in the approved proposal.

To whom:
Researchers who provide a methodologically sound proposal to achieve the aims mentioned in the approved proposal.

Conditions:
For personal use only.

Where to obtain:
Proposals of request to access the data should be sent to tawabkhallil2013@gmail.com. To gain access data requestors will need to sign data access agreement.

How to obtain:
Proposals of request to access the data should be sent to tawabkhallil2013@gmail.com. To gain access data requestors will need to sign data access agreement.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Muhammad Tawab Khalil</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>AFIRM, Rawalpindi</address>
        <city>Rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>4600</zip>
        <telephone>+92 51 5418692</telephone>
        <email>tawabkhalil2013@gmail.com</email>
        <affiliation>Armed Forces of Rehabilitation Medicine, Rawalpindi</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Muhammad Tawab Khalil</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rawalpindi Cantonment</address>
        <city>Rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>46000</zip>
        <telephone>+92 51 5418692</telephone>
        <email>tawabkhalil2013@gmail.com</email>
        <affiliation>Armed Forces Institute of Rehabilitation Medicine</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Intervention Group: All individuals with symptoms of peripheral neuropathy of superficial radial nerve
Control Group: All individuals without symptoms of peripheral neuropathy of superficial radial nerve.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>All individuals with history of stroke, diabetes mellitus, hypertension, brachial plexus plexopathy, cervical radiculopathy, spinal cord injury.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G56.30</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Lesion of radial nerve, unspecified upper limb</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:</i_keyword>
      <i_keyword>Control group:</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Amplitude, Velocity and Latency period of Sensory Nerve Action Potential (SNAP). Timepoint: At the time of recruitment. Method of measurement: Nerve Conduction Study of Proximal part of Medial branch of SRN will be done anti-dromically on the affected side of participants of group-I and on both sides of participants of group-II. Stimulation electrodes will be applied 10 cm proximal to radial styloid. Recording electrode will be placed at Anatomical snuff box while Reference electrode will be place at first metacarpophalayngeal joint. Amplitude, Latency and Velocity of Sensory Nerve Action Potential(SNAP) will be recorded.</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>Combined Military Hospital Multan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-08</approval_date>
        <contact_name>CMH Multan Ethical Review Comittee</contact_name>
        <contact_address>Combined Military Hospital Multan Multan Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
