<?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>IRCT20220518054910N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-31</date_registration>
      <primary_sponsor>King Edward Medical University, Mayo Hospital Lahore</primary_sponsor>
      <public_title>COMPARISON OF THE EFFECTIVENESS OF CERVICAL TRANSLATORIC MOBILIZATIONS WITH CERVICAL STABILITY TRAINING IN FEMALE PATIENTS WITH CERVICOGENIC HEADACHE: A RANDOMIZED CONTROLLED TRIAL</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of Cervical Translatoric Mobilizations with Cervical Stability Training in female patients with Cervicogenic Headache</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>82</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64465</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Other design features: Parallel groups, single blinded, single setting, Randomization description: All the participants who came to the physiotherapy department were considered and screened for cervicogenic headache with restricted neck movements. 82 patients were allotted to two groups i.e.; group A(CTM) and group B(CST) via a computer-generated randomized list, 41 in each group. Considered the inclusion and exclusion criteria before concerning them in the study. Informed consent was taken whether they were willing to participate or not in written form, Blinding description: Participants were allocated to two treatment groups named A and B. None of the participants know which of the two modes of ultrasound has been used on him/her as both modes require the ultrasound machinery and nothing else. The care provider has been giving treatment according to the protocols decided and he/she has no role in measuring the results. The outcome assessor or the investigator is involved in the outcome measurements of both groups and has no role in applying treatment protocols to the patients or the randomization. The data analyzer is involved in the analysis of data only and has no role in randomization, treatment application, or outcome measurement. None of the members of DSMB are involved in the application of randomization, treatment application, outcome measurement, or data analysis.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cervicogenic Headache.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Cervical Translatoric Mobilizations. Intervention 2: Intervention group: Cervical Stability Training.</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:
Data will be shared in the form of Excel and Microsoft Word files.

When:
6 months after publication

To whom:
Only available for people working in academic institutions

Conditions:
The person responsible for data updates will be reviewing requests for data. Data will be shared through email.

Where to obtain:
yashamafzal61@gmail.com

How to obtain:
Provide full detail of the reason you want to pursue data from my study. Then wait for a max of one month to receive it if the request for data is approved.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Yasham Afzal</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nila Gumbad Chowk, Neela Gumbad Lahore.</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 323 7888180</telephone>
        <email>yashamafzal61@gmail.com</email>
        <affiliation>King Edward Medical University, Mayo Hospital Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Yasham Afzal</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nila Gumbad Chowk, Neela Gumbad Lahore.</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 323 7888180</telephone>
        <email>yashamafzal61@gmail.com</email>
        <affiliation>King Edward Medical University, Mayo Hospital Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The study will include female patients aged 20-40 years.
A diagnosis of cervicogenic headache (pain aggravated by neck movement, sustained position or external pressure, restricted cervical range of motion, and unilateral pain starting in the neck and radiating to the frontotemporal region)
Positive cervical flexion-rotation test (FRT)</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Patients previously receiving treatment for underlying pathology.
Patients presented with red flag signs for headache.
Patients presented with migraine.
Patients in whom manual therapy is contraindicated.
Patients who are diagnosed with radiculopathy.
Patients who are taking analgesics.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G44</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other headache syndromes</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Cervical Translatoric Mobilizations</i_keyword>
      <i_keyword>Intervention group: Cervical Stability Training</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before applying Intervention and at week 3 and week 6 of intervention. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Range of Motion (Upper Cervical). Timepoint: Before applying Intervention and at week 3 and week 6 of intervention. Method of measurement: Goniometer.</prim_outcome>
      <prim_outcome>Range of Motion (General Cervical). Timepoint: Before applying Intervention and at week 3 and week 6 of intervention. Method of measurement: Goniometer.</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>King Edward Medical University, Mayo Hospital Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-05</approval_date>
        <contact_name>Advanced Studies and Research Board</contact_name>
        <contact_address>Neela Gumbad, New Anarkali, Lahore LAHORE Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
