<?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>IRCT20210813052160N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-22</date_registration>
      <primary_sponsor>Yasmin physiotherapy center</primary_sponsor>
      <public_title>Effect of cervical manipulation in posture related cervicogenic headache due to use of electronic media in COVID -19.</public_title>
      <acronym></acronym>
      <scientific_title>Effect of cervical manipulation in posture related cervicogenic headache</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58112</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Randomization is being accomplished  using simple random sampling by mean of lottery method, Blinding description: The participant will not be aware of the study groups and this will be carried out by keeping them anonymous for the study period.</study_design>
      <phase>3</phase>
      <hc_freetext>Cervicogenic headache.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group A: The participants will receive baseline treatment of hot -pack plus neck isometrics with additional treatment of  Cervical manipulation. Intervention 2: Control group B: The participants will receive only  base line treatment  (20 mints of hot pack and neck isometrics).</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is As we have signed and assured the participants that there data will not be shared any where else other than  study</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saba Riaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hunjra house verpal chattha,tehsil Wazirabad,District ,Gujranwala</address>
        <city>Gujranwala</city>
        <country1>Pakistan</country1>
        <zip>52080</zip>
        <telephone>+92 55 6706678</telephone>
        <email>sabariaz458@gmail.com</email>
        <affiliation>Sial hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saba Riaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hunjra house verpal chattha,tehsil Wazirabad,District ,Gujranwala</address>
        <city>Gujranwala</city>
        <country1>Pakistan</country1>
        <zip>52080</zip>
        <telephone>+92 55 6706678</telephone>
        <email>sabariaz458@gmail.com</email>
        <affiliation>Sial hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Male and female participants
participants of ages between 20-40 years
participants with primary complaint of headache
Frequency of at least once a week from minimum of last 3 months and Minimum Neck Disability Index (NDI) disability score of 20 % or greater
participants eligible after being diagnosed cervicogenic headache using revised diagnostic criteria established by the Cervicogenic Headache International Study Group (CHISG)
joint tenderness exhibited in at least one of the three upper cervical joints (C0-C3) on assessing through manual palpation
non-throbbing
non-lancinating pain of moderate to severe intensity were included into the study.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Participants having any other primary headaches e.g. migraine or tension headaches
presence of contraindications to cervical spinal manipulation like tumor, pregnancy, rheumatoid arthritis, fracture, metabolic diseases, infection, dislocation, osteoporosis
anticoagulant user, chronic corticosteroid user
previous 3 months history of head or neck surgery
previous history of a whiplash injury within six weeks
bilateral headaches
cervical spine stenosis
bilateral upper limb symptoms
presence of any signs showing central nervous system (CNS) involvement, presence of 2 or more nerve root compression signs, exhibiting “5 D’s” &amp; “3 N’s</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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>Intervention Group A: The participants will receive baseline treatment of hot -pack plus neck isometrics with additional treatment of  Cervical manipulation.</i_keyword>
      <i_keyword>Control group B: The participants will receive only  base line treatment  (20 mints of hot pack and neck isometrics)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cervicogenic headache. Timepoint: Before intervention, 2nd and 4th week. Method of measurement: Numerical Pain Rating Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Functional Disability. Timepoint: Before intervention and 4th week. Method of measurement: Neck Disability Index.</sec_outcome>
      <sec_outcome>Quality of life. Timepoint: Before intervention and 4th week. Method of measurement: Headache Impact Test -6.</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>Yasmin physiotherapy center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-21</approval_date>
        <contact_name>Ethics and Technical committee of The University of Faislabad</contact_name>
        <contact_address>university Town, Sargodha Road Faislabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
