<?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>IRCT20200101045970N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-30</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Pain Neurophysiology Education in the treatment of Cervicogenic headache</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Pain Neurophysiology Education in the treatment of Cervicogenic headache: A randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44657</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, due to the small number of samples, in consultation with a statistician, it was decided to use the random blocking method. Blocking is usually used to balance the number of samples assigned to each of the groups studied.
Statistics expert using the website
  https://www.sealedenvelope.com/simple-randomiser/v1/lists 15 blocks of 2 were designed considering that we had 2 groups.

Divides patients according to this table is unaware of the study, Blinding description: Assessments are performed by a person who is unaware of the groups. 
After completing the questionnaires, the subjects were randomly divided into two groups with block method by one person who was unaware of the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cervicogenic Headache.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Pain Neurophysiology Education: This method is taught to patients by the student. In the pain neurophysiology group, the training will be such that using simple methods such as presenting with PowerPoint slides, pain transfer methods will be explained in 4 sessions of one hour and one session per week in a simple way. Pain neurophysiology training based on the book Explain pain supercharged by G.L. Mosely and D.S. It will be Butler. This training includes explanations of the origin of acute pain in the nervous system, how to change acute pain to chronic, central sensitivity, the role of the brain in perceiving pain, psychosocial factors affecting pain and cognitive and behavioral reactions related to pain and pain management. There is no reference to the anatomy and mechanics of the neck in these sessions. Intervention 2: Control group: Conventional Physiotherapy: This method is applied by a physiotherapist in the physiotherapy department. In this group, for 10 sessions, use Conventional TENS with a frequency of 100 Hz with a duration of 100 microseconds for 20 minutes. The electrode will be placed so that two electrodes from one channel are placed on the paravertebral muscles of the neck and two electrodes from the other channel are placed on the upper trapezius muscles. The hot pack will also be used at the same time as using TENS on the electrodes. In addition, Continuous ultrasound waves with a frequency of 1 MHz and an intensity of 1 w / cm2 will be used for 5 minutes on the posterior muscles of the upper vertebrae. It also teaches the patient exercise therapy using active exercises.</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 We are not able to publish data ethically and misuse information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Ehsan Ghasemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar jreeb Ave.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3669 3089</telephone>
        <email>eghasemi@rehab.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Ehsan Ghasemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jreeb Ave.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3669 3089</telephone>
        <email>eghasemi@rehab.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Unilateral  headache that spreads to the frontotemporal region.
Pain exacerbation associated with movement or inappropriate neck postures.
Moderate to severe non-pulsatile pain based on Numeric Rating Pain Scale not lower than grade 2
Enough reading and writing skills are also a requirement for inclusion.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Neck Radiculopathy
History of neck injury
Any other neck pain agent, including osteoarthritis
History of cervical trigger point treatment by manual or dry needle treatment over the past 6 months
Cognitive disorders
Previous history of primary headache diagnosis (such as migraine and tension headache)
Use of painkillers during treatment
Previous history of neck or shoulder surgery
Failure to co-operate</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G44.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other specified headache syndromes</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Pain Neurophysiology Education: This method is taught to patients by the student. In the pain neurophysiology group, the training will be such that using simple methods such as presenting with PowerPoint slides, pain transfer methods will be explained in 4 sessions of one hour and one session per week in a simple way. Pain neurophysiology training based on the book Explain pain supercharged by G.L. Mosely and D.S. It will be Butler. This training includes explanations of the origin of acute pain in the nervous system, how to change acute pain to chronic, central sensitivity, the role of the brain in perceiving pain, psychosocial factors affecting pain and cognitive and behavioral reactions related to pain and pain management. There is no reference to the anatomy and mechanics of the neck in these sessions.</i_keyword>
      <i_keyword>Control group: Conventional Physiotherapy: This method is applied by a physiotherapist in the physiotherapy department. In this group, for 10 sessions, use Conventional TENS with a frequency of 100 Hz with a duration of 100 microseconds for 20 minutes. The electrode will be placed so that two electrodes from one channel are placed on the paravertebral muscles of the neck and two electrodes from the other channel are placed on the upper trapezius muscles. The hot pack will also be used at the same time as using TENS on the electrodes. In addition, Continuous ultrasound waves with a frequency of 1 MHz and an intensity of 1 w / cm2 will be used for 5 minutes on the posterior muscles of the upper vertebrae. It also teaches the patient exercise therapy using active exercises.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity. Timepoint: Before and after treatment and one month follow up. Method of measurement: Visual Analog Scale.</prim_outcome>
      <prim_outcome>Pain frequency. Timepoint: Before and after treatment and one month follow up. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Pain Duration. Timepoint: Before and after treatment and one month follow up. Method of measurement: Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Headache Disability Inventory. Timepoint: Before and after treatment and one month follow up. Method of measurement: Headache Disability Inventory.</sec_outcome>
      <sec_outcome>Pain Catastrophizing rate. Timepoint: Before and after treatment and one month follow up. Method of measurement: Pain Catastrophizing Scale.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-08-04</approval_date>
        <contact_name>Isfahan Medical University</contact_name>
        <contact_address>Hezar Jrib Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
