<?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>IRCT20230815059155N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-15</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of mobilization with movement technique in athletes with cervicogenic headache</public_title>
      <acronym></acronym>
      <scientific_title>The effect of mobilization with movement technique on pain, disability and range of motion in athletes with chronic cervicogenic headache</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72079</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After entering the study, participants are randomly assigned to two treatment groups, mobilization with movement and control group, using block balanced randomization method. generatorslist.com system is used to determine random numbers (random allocation); This method is done with the help of four-digit blocks including even and odd numbers. For this purpose, 4-digit numbers are chosen, which have 2 even digits and 2 odd digits; Each figure represents each person participating in the study. Even numbers indicate the group of mobilization with movement and odd numbers indicate the treatment group of common exercise therapy, Blinding description: At the end of the random allocation, the numbers will be placed inside the numbered envelopes and after the initial evaluation by the examiner, the numbered envelopes corresponding to the sequential number of each person entered into the study will be given to him. Finally, after each participant enters the treatment sessions, the therapist opens the envelope related to the person in question and applies therapeutic interventions based on the numbers inside the envelope. Also, the evaluator will be unaware of which group each subject is in.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cervicogenic headache.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: This group is treated with the Mulligan cervical Sustained Natural Apophyseal Glide technique on the C2 vertebra. This technique is performed for twenty minutes in each session, three times a week for four weeks. Intervention 2: Control group: This group is trained to strengthen deep neck flexors using a pressure biofeedback device in such a way that the exercises are repeated for 3 sets, and 2 mm of mercury is added to the pressure in each set. The pressure increases from 22 to 32 mmHg during 4 weeks of treatment. Each exercise set is held for 10 seconds and repeated 10 times; 5 seconds rest between each repetition and 2 minutes rest between each set. Also, stretching of the suboccipital, scalene, upper trapezius, levator scapula and sternocleidomastoid muscles is also done for these patients. The duration of stretching for each muscle is 10 seconds and 5 seconds of rest with the number of repetitions of 10 repetitions in the form of a training set.</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:
All data collected from participants after de-identification, study protocol, statistical analysis plan, designed forms for informed consent and questionnaires, clinical report of the study, codes used in the analysis and information about data classification after can be published upon request from the researcher after the of the study.

When:
The period of access to data documentation begins 6 months after the results are published.

To whom:
These documents will be accessible to researchers related to academic and scientific institutions and physiotherapists working in other centers.

Conditions:
These data are accessible if they are not used for the purpose of analysis, conclusion and statistical review in another study (except for review and systematic studies).

Where to obtain:
Nima Mirzaaghatabar: nima.mirzaaghatabar@gmail.com
Sanaz Shanbehzadeh: sanazshanbehzadeh@gmail.com

How to obtain:
By sending a message to the given email addresses, the person must first mention the name, degree and field of study and the related center or institution and present the data he needs and what it will be used for. Then after checking and if the necessary conditions are met, the requested documents will be sent to the person within a week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sanaz Shanbehzade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation Science of Iran University, Madadkaran Alley, Shahnazari Ave, Madar Square, Mirdamad</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913487</zip>
        <telephone>+98 21 2222 8051</telephone>
        <email>sanazshanbehzadeh@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sanaz Shanbehzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation Science of Iran University, Madadkaran Alley, Shahnazari Ave, Madar Square, Mirdamad</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913487</zip>
        <telephone>+98 21 2222 8051</telephone>
        <email>sanazshanbehzadeh@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of cervicogenic headache with diagnostic index of World Headache Society
Positive flexion-rotation test
Have headaches for 3 months or more
Recreational athletes
Between 20 and 50 years old</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Have neurological disorders or neck arthritis
History of fracture, injury or surgery in the neck area
Congenital malformations
Bone infection
Cervical disc herniation or upper limb radiculopathy
Migraine
Performing other therapeutic interventions at the same time
Absence in 3 consecutive sessions or more</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G44.86</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cervicogenic headache is a medical classification as listed by WHO under the range - Diseases of the nervous system</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: This group is treated with the Mulligan cervical Sustained Natural Apophyseal Glide technique on the C2 vertebra. This technique is performed for twenty minutes in each session, three times a week for four weeks.</i_keyword>
      <i_keyword>Control group: This group is trained to strengthen deep neck flexors using a pressure biofeedback device in such a way that the exercises are repeated for 3 sets, and 2 mm of mercury is added to the pressure in each set. The pressure increases from 22 to 32 mmHg during 4 weeks of treatment. Each exercise set is held for 10 seconds and repeated 10 times; 5 seconds rest between each repetition and 2 minutes rest between each set. Also, stretching of the suboccipital, scalene, upper trapezius, levator scapula and sternocleidomastoid muscles is also done for these patients. The duration of stretching for each muscle is 10 seconds and 5 seconds of rest with the number of repetitions of 10 repetitions in the form of a training set.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Headache intensity based on Visual Analog Scale. Timepoint: Before intervention, at the end of intervention &amp; 4 weeks after the end of intervention. Method of measurement: Visual Analog Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Disability. Timepoint: Before intervention, at the end of intervention &amp; 4 weeks after the end of intervention. Method of measurement: Henry Ford Hospital Headache Disability Inventory.</sec_outcome>
      <sec_outcome>Upper cervical range of motion. Timepoint: Before intervention, at the end of intervention &amp; 4 weeks after the end of intervention. Method of measurement: Flexion-rotation test &amp; Cervical Range of Motion device.</sec_outcome>
      <sec_outcome>Headache duration. Timepoint: Before intervention, at the end of intervention &amp; 4 weeks after the end of intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Headache frequency. Timepoint: Before intervention, at the end of intervention &amp; 4 weeks after the end of intervention. Method of measurement: Questionnaire.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-08-06</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>No. 1, Shahid Asadi Alley, Haftome tir Ave., Danesh-amuz Blvd., Hafte tir Cross road, Karaj Karaj Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
